TerminatedNCT03216005INFINITE-OUSUpdated Apr 23, 2026Results posted

Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

An interventional study of BlueLeaf System in Chronic Venous Insufficiency, sponsored by Intervene, Inc.. Terminated at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Intervene, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated

Project suspended by sponsor

Phase: Not applicable
Study type: Interventional
Enrollment: 14
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).

Read the detailed description

Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity. The BlueLeaf System is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of CVI. Subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment.

Conditions studied

Chronic Venous Insufficiency

In context

Lead sponsor

Intervene, Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6;
Failed compression therapy of at least 6 months' duration;
Deep system venous reflux characterized by >1 second reflux time;
Presence of at least one target site within the target vessel.

Exclusion criteria

Exclusion Criteria:

Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms;
Deep venous intervention in the target limb or outflow vessels within 6 months of consent;
Significant peripheral arterial disease with an ankle-brachial index of \<0.50 or with incompressible vessels;
Acute deep venous thrombosis (DVT) within 3 months of consent;
History of stroke within the last 6 months;
Flow-limiting venous outflow obstruction central to the intended target sites;
Insufficient inflow through the treatment vein upon manual augmentation;
Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites;
Chronic renal insufficiency with creatinine level of ≥2mg/dL;
Hemoglobin level \<9.0 mg/dL;
Platelet count \<50,000 or >1,000,000 per mm3;
Total white blood cell count \<3,000/mm3;
Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested;
Non-ambulatory patients;

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 14 participants (actual)

Study arms

Experimental
BlueLeaf System
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.
Device: BlueLeaf System

Interventions

DeviceBlueLeaf System
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

What researchers measure

Primary outcomes

Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment
Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up
Time frame: Baseline, 7-day, 30-day
Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT)
Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit
Time frame: 30-day post-procedure

Secondary outcomes

Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment
Rates (count) of participants with DVTs in the target vessel at the 90-day and 210-day follow-up assessed by follow-up imaging
Time frame: 90-day, 210-day
Change in Reflux Time (RT) in the Primary Treated Vein Segment
Assessment of the reflux time in the primary treated vein segment. Change in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 90-day and 210-day follow-up visits were assessed; the outcome is reported as the % change in the reflux time from Baseline
Time frame: 90-day, 210-day

Other outcomes

Procedure Technical Success
Procedure technical success is defined as delivery of the system to the target vessel and formation of at least one mobile autogenous valve (as measured with intravascular ultrasound (IVUS) or venography following valve formation) without target vessel occlusion at the conclusion of the index procedure
Time frame: Procedure
Average Revised Venous Clinical Severity Score (rVCSS)
Assessment of the average (mean) rVCSS at Baseline, 30D and 90D. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, \>/=3), duration of ulcers (\<3 months, \>3 months but \<1 year, not healed for \>1 year), active ulcer size (diameter \<2cm, diameter 2-6cm, and diameter \>6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). A higher total score would indicate a worse outcome (total score can range from 0 to 30); the outcome is reported as the average (mean) scores at Baseline, 30D and 90D.
Time frame: Baseline, 30-day, 90-day
Change in Revised Venous Clinical Severity Score (rVCSS)
Assessment of the average (mean) change in rVCSS at 30D and 90D compared to Baseline. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, \>/=3), duration of ulcers (\<3 months, \>3 months but \<1 year, not healed for \>1 year), active ulcer size (diameter \<2cm, diameter 2-6cm, and diameter \>6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). An increase in total score over time would indicate a worse outcome; the outcome is reported as the average (mean) numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Revised Venous Clinical Severity Score").
Time frame: 30-day, 90-day
Average Villalta Scale Score
Assessment of the average (mean) Villalta Scale Score at Baseline, 30D, and 90D. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average (mean) scores at Baseline, 30D and 90D. A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease.
Time frame: Baseline, 30-day, 90-day
Change in Villalta Scale Score
Assessment of average (mean) change in Villalta Scale Score at 30D and 90D compared to Baseline. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Villalta Scale Score"). A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease.
Time frame: 30-day, 90-day
Average VEINES-QoL/Sym Score
Assessment of the average (mean) VEINES-QoL/Sym Score at Baseline, 30D, 90D and 210D. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). VEINES-QoL/Sym scores can range from 0-100, where higher scores indicate better outcomes (higher quality of life and less severe symptoms). The calculated mean VEINES-QoL/Sym scores at 30D, 90D and 210D post-procedure are provided.
Time frame: Baseline, 30-day, 90-day, 210-day
Change in VEINES-QoL/Sym Score
Assessment of the change in the median (min, max) VEINES-QoL/Sym Score at 30D, 90D and 210D compared to Baseline. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). The outcome is reported as the change in median (min, max) score at 30D, 90D and 210D compared to the Baseline score (for Baseline scores refer to outcome measure "Average VEINES-QoL/Sym Score").
Time frame: 30-day, 90-day, 210-day

Results

Posted Apr 23, 2026

Limitations and caveats

The trial was terminated early leading to a limited number of subjects analyzed. Specifically, there was limited data available for reporting purposes.

Participant flow

Participant flow — Overall Study
Milestone	BlueLeaf System
Started	14
Completed	0
Not completed	14
Withdrew: Underwent investigational procedure, but trial was terminated early by sponsor	11
Withdrew: Unknown (information not available/status unknown)	3

Outcome measures

PrimaryPrimary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment

Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up

Time frame:: Baseline, 7-day, 30-day
Reported as:: Mean · percentage change from Baseline

Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment
percentage change from Baseline	BlueLeaf System - Proximal Femoral Vein (FV) Segment	BlueLeaf System - Distal Femoral Vein (FV) Segment	BlueLeaf System - Mid Popliteal Segment
7-day % change from Baseline	32.0 ± 72.5	41.2 ± 54.3	59.1 ± 67.6
30-day % change from Baseline	18.8 ± 85.3	39.3 ± 80.6	65.1 ± 94.3

PrimaryPrimary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT)

Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit

Time frame:: 30-day post-procedure
Reported as:: Count of participants · Participants

Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT)
Participants	BlueLeaf System - Proximal Femoral Vein (FV) Segment	BlueLeaf System - Distal Femoral Vein (FV) Segment	BlueLeaf System - Mid Popliteal Segment
Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT)	0	0	0

SecondaryNumber of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment

Rates (count) of participants with DVTs in the target vessel at the 90-day and 210-day follow-up assessed by follow-up imaging

Time frame:: 90-day, 210-day
Reported as:: Number · participants

Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment
participants	BlueLeaf System - Proximal Femoral Vein (FV) Segment	BlueLeaf System - Distal Femoral Vein (FV) Segment	BlueLeaf System - Mid Popliteal Segment
90-day	0	0	0
210-day	0	0	0

SecondaryChange in Reflux Time (RT) in the Primary Treated Vein Segment

Assessment of the reflux time in the primary treated vein segment. Change in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 90-day and 210-day follow-up visits were assessed; the outcome is reported as the % change in the reflux time from Baseline

Time frame:: 90-day, 210-day
Reported as:: Mean · percent change from baseline values

Change in Reflux Time (RT) in the Primary Treated Vein Segment
percent change from baseline values	BlueLeaf System - Proximal Femoral Vein (FV) Segment	BlueLeaf System - Distal Femoral Vein (FV) Segment	BlueLeaf System - Mid-Popliteal Segment
90-day % change from Baseline	40.9 ± 79.3	16.9 ± 53.4	50.8 ± 107.7
210-day % change from Baseline	45.2 ± 60.5	75.6 ± 11.6	122.4 ± 83.3

Other pre-specifiedProcedure Technical Success

Procedure technical success is defined as delivery of the system to the target vessel and formation of at least one mobile autogenous valve (as measured with intravascular ultrasound (IVUS) or venography following valve formation) without target vessel occlusion at the conclusion of the index procedure

Time frame:: Procedure
Reported as:: Count of participants · Participants

Procedure Technical Success
Participants	BlueLeaf System
Procedure Technical Success	10

Other pre-specifiedAverage Revised Venous Clinical Severity Score (rVCSS)

Assessment of the average (mean) rVCSS at Baseline, 30D and 90D. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, \>/=3), duration of ulcers (\<3 months, \>3 months but \<1 year, not healed for \>1 year), active ulcer size (diameter \<2cm, diameter 2-6cm, and diameter \>6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). A higher total score would indicate a worse outcome (total score can range from 0 to 30); the outcome is reported as the average (mean) scores at Baseline, 30D and 90D.

Time frame:: Baseline, 30-day, 90-day
Reported as:: Mean · score on a scale

Average Revised Venous Clinical Severity Score (rVCSS)
score on a scale	BlueLeaf System
Baseline	18.0 ± 4.0
30-day	13.0 ± 5.0
90-day	13.0 ± 5.0

Other pre-specifiedChange in Revised Venous Clinical Severity Score (rVCSS)

Assessment of the average (mean) change in rVCSS at 30D and 90D compared to Baseline. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, \>/=3), duration of ulcers (\<3 months, \>3 months but \<1 year, not healed for \>1 year), active ulcer size (diameter \<2cm, diameter 2-6cm, and diameter \>6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). An increase in total score over time would indicate a worse outcome; the outcome is reported as the average (mean) numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Revised Venous Clinical Severity Score").

Time frame:: 30-day, 90-day
Reported as:: Mean · score on a scale

Change in Revised Venous Clinical Severity Score (rVCSS)
score on a scale	BlueLeaf System
30-day mean change in score from Baseline	-5.0 ± 3.0
90-day mean change in score from Baseline	-5.0 ± 4.0

Other pre-specifiedAverage Villalta Scale Score

Assessment of the average (mean) Villalta Scale Score at Baseline, 30D, and 90D. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average (mean) scores at Baseline, 30D and 90D. A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease.

Time frame:: Baseline, 30-day, 90-day
Reported as:: Mean · score on a scale

Average Villalta Scale Score
score on a scale	BlueLeaf System
Baseline	6.0 ± 5.0
30-day	3.0 ± 3.0
90-day	3.0 ± 4.0

Other pre-specifiedChange in Villalta Scale Score

Assessment of average (mean) change in Villalta Scale Score at 30D and 90D compared to Baseline. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Villalta Scale Score"). A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease.

Time frame:: 30-day, 90-day
Reported as:: Mean · score on a scale

Change in Villalta Scale Score
score on a scale	BlueLeaf System
30-day change in score from Baseline	-4.0 ± 4.0
90-day change in score from Baseline	-3.0 ± 3.0

Other pre-specifiedAverage VEINES-QoL/Sym Score

Assessment of the average (mean) VEINES-QoL/Sym Score at Baseline, 30D, 90D and 210D. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). VEINES-QoL/Sym scores can range from 0-100, where higher scores indicate better outcomes (higher quality of life and less severe symptoms). The calculated mean VEINES-QoL/Sym scores at 30D, 90D and 210D post-procedure are provided.

Time frame:: Baseline, 30-day, 90-day, 210-day
Reported as:: Mean · score on a scale

Average VEINES-QoL/Sym Score
score on a scale	BlueLeaf System
VEINES-Sym: Baseline	50.0 ± 6.7
VEINES-Sym: 30-day	50.0 ± 6.9
VEINES-Sym: 90-day	50.0 ± 7.6
VEINES-Sym: 210-day	50.0 ± 4.0
VEINES-QoL: Baseline	50.0 ± 6.7
VEINES-QoL: 30-day	50.0 ± 6.9
VEINES-QoL: 90-day	50.0 ± 6.8
VEINES-QoL: 210-day	50.0 ± 2.9

Other pre-specifiedChange in VEINES-QoL/Sym Score

Assessment of the change in the median (min, max) VEINES-QoL/Sym Score at 30D, 90D and 210D compared to Baseline. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). The outcome is reported as the change in median (min, max) score at 30D, 90D and 210D compared to the Baseline score (for Baseline scores refer to outcome measure "Average VEINES-QoL/Sym Score").

Time frame:: 30-day, 90-day, 210-day
Reported as:: Median · score on a scale

Change in VEINES-QoL/Sym Score
score on a scale	BlueLeaf System
VEINES-Sym: 30-day change in median score from Baseline	2.4 (-9.1 to 7.2)
VEINES-Sym: 90-day change in median score from Baseline	1.8 (-8.8 to 9.4)
VEINES-Sym: 210-day change in median score from Baseline	-5.2 (-11.2 to 0.8)
VEINES-QoL: 30-day change in median score from Baseline	0.8 (-5.9 to 6.4)
VEINES-QoL: 90-day change in median score from Baseline	1.8 (-4.4 to 4.8)
VEINES-QoL: 210-day change in median score from Baseline	-5.1 (-11.1 to 0.9)

Adverse events

Collected over Up to 210-days post-procedure (longest follow-up available at the time of trial termination). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BlueLeaf System	0/11 (0%)	3/11 (27.3%)	11/11 (100%)

Most frequent serious events

Most frequent serious events
Event	BlueLeaf System
HematomaInjury, poisoning and procedural complications	1/11
Access site injuryInjury, poisoning and procedural complications	1/11
Respiratory arrestInjury, poisoning and procedural complications	1/11

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	BlueLeaf System
Autogenous Valve Formation RelatedSurgical and medical procedures	7/11
Access Site RelatedInjury, poisoning and procedural complications	5/11
NauseaInjury, poisoning and procedural complications	1/11
Bruising of hand and wristInjury, poisoning and procedural complications	1/11
PainInjury, poisoning and procedural complications	1/11
HypotensionInjury, poisoning and procedural complications	1/11
BradycardiaCardiac disorders	1/11
Urinary Tract InfectionInfections and infestations	1/11
Bleeding at biopsy siteInjury, poisoning and procedural complications	1/11
Infection of pre-existing ulcerInfections and infestations	1/11

Baseline characteristics

Clinical investigation was terminated prematurely by the Sponsor; the data is available for 11 subjects (which is the analysis cohort).

Age, Continuous
Age, Continuous(years)	BlueLeaf System
Mean	67.0 ± 7.0

Sex: Female, Male
Sex: Female, Male(Participants)	BlueLeaf System
Female	5
Male	6

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	BlueLeaf System

Study Limb
Study Limb(Participants)	BlueLeaf System
Right	6
Left	5

Duration of Chronic Venous Insufficiency (CVI)
Duration of Chronic Venous Insufficiency (CVI)(years)	BlueLeaf System
Mean	12.2 ± 14.2

Prior Deep Vein Thrombosis (DVT)
Prior Deep Vein Thrombosis (DVT)(Participants)	BlueLeaf System
Yes	3
No	8

Anticoagulant Use at Baseline
Anticoagulant Use at Baseline(Participants)	BlueLeaf System
Yes	5
No	6

Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) Classification(Participants)	BlueLeaf System
C3 - edema	0
C4 - changes in skin and subcutaneous tissue secondary to chronic venous disease	3
C5 - healed	3
C6 - active venous ulcer	5

Study locations

5 sites

Royal Prince Alfred
Camperdown, New South Wales 2050, Australia
Prince of Wales
Randwick, New South Wales 2031, Australia
Vancouver Coastal Health Research Institute
Vancouver, British Columbia V5Z 1M9, Canada
Auckland City Hospital
Auckland, New Zealand
Clinical Trials New Zealand Ltd
Hamilton, New Zealand

References and documents

Study documents

Protocol and statistical analysis plan · Nov 3, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03216005
Lead sponsor: Intervene, Inc.
Responsible party: Sponsor
First posted: Jul 12, 2017
Start date: Nov 2, 2017
Primary completion: Oct 30, 2023
Completion: Oct 30, 2023
Results posted: Apr 23, 2026
Last update: Apr 23, 2026

Study contacts

Jeff Elkins

study director · Intervene, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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