A Phase 3 interventional study of PROPEL Mini Sinus Implant. and Sinus Surgery alone in Chronic Sinusitis, sponsored by Intersect ENT. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-15.
Sponsored by Intersect ENT · Phase 3, Interventional, and Treatment
The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening following frontal sinus surgery in patients with chronic sinusitis.
This is a prospective, randomized, blinded, controlled, multicenter study enrolling two consecutive cohorts of up to 80 patients each (Propel Mini cohort followed by Propel Nova cohort). The study patients will undergo implant placement on one side following ESS that includes bilateral frontal sinus surgery by traditional surgical technique or balloon dilation.
415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.
This study's enrollment of 160 is above the median of 60 across 313 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →Intersect ENT is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Propel Mini placed in frontal sinus opening following ESS
Device: PROPEL Mini Sinus Implant.
Sinus Surgery only: cohort 1: ESS with standard post-operative care.
Procedure: Sinus Surgery alone
Propel Nova placed in frontal sinus opening following ESS
Device: Propel Nova Sinus Implant
Sinus Surgery only: cohort 2: ESS with standard post-operative care.
Procedure: Sinus Surgery alone
Placement of sinus implant following frontal sinus surgery
Sinus surgery only, without implant placement
Placement of sinus implant following frontal sinus surgery
Also known as: PROPEL contour Sinus Implant
Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)
The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
Time frame: Day 30
Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)
The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
Time frame: Day 30
Need for Post-operative Interventions (Propel Mini Cohort)
Need for post-operative interventions by clinical investigators at Day 30 Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
Time frame: Day 30
Need for Surgical Interventions (Propel Mini Cohort)
Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO 1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) 2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) 3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)
Time frame: Day 30
Inflammation (Propel Mini Cohort)
The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.
Time frame: Day 30
Occlusion/Restenosis (Propel Mini Cohort)
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent 1. Restenosed/Partially Occluded 2. Occluded
Time frame: Day 30
Need for Post-operative Interventions (Propel Nova Cohort)
Need for post-operative interventions by clinical investigators at Day 30. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
Time frame: Day 30
Need for Surgical Interventions (Propel Nova Cohort)
Need for Surgical Interventions by clinical investigators at Day 30 Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO 1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) 2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) 3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)
Time frame: Day 30
Inflammation (Propel Nova Cohort)
The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.
Time frame: Day 30
Occlusion/Restenosis (Propel Nova Cohort)
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent 1. Restenosed/Partially Occluded 2. Occluded
Time frame: Day 30
| Milestone | PROPEL Mini Sinus Implant | PROPEL Nova Sinus Implant |
|---|---|---|
| Started | 80 | 80 |
| Completed | 79 | 79 |
| Not completed | 1 | 1 |
The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
| percent sinuses requiring intervention | PROPEL Mini Sinus Implant | Sinus Surgery Only: Cohort 1 |
|---|---|---|
| Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort) | 38.8 (27.1 to 51.5) | 62.7 (50.0 to 74.2) |
The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
| percentage sinus requiring intervention | PROPEL Nova Sinus Implant | Sinus Surgery Only: Cohort 2 |
|---|---|---|
| Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort) | 11.5 (4.7 to 22.2) | 32.8 (21.3 to 46.0) |
Need for post-operative interventions by clinical investigators at Day 30 Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
| percentage of evaluable sinuses | PROPEL Mini Sinus Implant | Sinus Surgery Only: Cohort 1 |
|---|---|---|
| Need for Post-operative Interventions (Propel Mini Cohort) | 16.5 (9.1 to 26.5) | 41.8 (30.8 to 53.4) |
Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO 1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) 2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) 3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)
| percentage of evaluable sinuses | PROPEL Mini Sinus Implant | Sinus Surgery Only: Cohort 1 |
|---|---|---|
| Need for Surgical Interventions (Propel Mini Cohort) | 4.0 | 16.0 |
The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.
| 100-mm VAS | PROPEL Mini Sinus Implant | Sinus Surgery Alone: Cohort 1 |
|---|---|---|
| Inflammation (Propel Mini Cohort) | 24.7 ± 27.02 | 41.3 ± 29.34 |
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent 1. Restenosed/Partially Occluded 2. Occluded
| percentage of evaluable sinuses | PROPEL Mini Sinus Implant | Sinus Surgery Only: Cohort 1 |
|---|---|---|
| Occlusion/Restenosis (Propel Mini Cohort) | 21.1 (12.5 to 31.9) | 46.1 (34.5 to 57.9) |
Need for post-operative interventions by clinical investigators at Day 30. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
| percentage of evaluable sinuses | PROPEL Nova Sinus Implant | Sinus Surgery Only: Cohort 2 |
|---|---|---|
| Need for Post-operative Interventions (Propel Nova Cohort) | 16.0 (8.6 to 26.3) | 33.3 (22.9 to 45.2) |
Need for Surgical Interventions by clinical investigators at Day 30 Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO 1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) 2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) 3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)
| percentage of evaluable sinuses | PROPEL Nova Sinus Implant | Sinus Surgery Only: Cohort 2 |
|---|---|---|
| Need for Surgical Interventions (Propel Nova Cohort) | 4.0 | 14.7 |
The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.
| 100-mm VAS | PROPEL Nova Sinus Implant | Sinus Surgery Alone: Cohort 2 |
|---|---|---|
| Inflammation (Propel Nova Cohort) | 23.1 ± 24.23 | 35.6 ± 31.12 |
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent 1. Restenosed/Partially Occluded 2. Occluded
| percentage of evaluable sinuses | PROPEL Nova Sinus Implant | Sinus Surgery Only: Cohort 2 |
|---|---|---|
| Occlusion/Restenosis (Propel Nova Cohort) | 13.3 (6.6 to 23.2) | 36.0 (25.2 to 47.9) |
Collected over Propel Mini cohort: 90 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PROPEL Mini Sinus Implant | — | 3/80 (3.8%) | 43/80 (53.8%) |
| PROPEL Nova Sinus Implant | — | 1/80 (1.3%) | 36/80 (45%) |
| Event | PROPEL Mini Sinus Implant | PROPEL Nova Sinus Implant |
|---|---|---|
| Cerebrovascular AccidentVascular disorders | 0/80 | 1/80 |
| DiverticulitisInfections and infestations | 1/80 | 0/80 |
| Respiratory tract infection fungalInfections and infestations | 1/80 | 0/80 |
| deep vein thrombosisVascular disorders | 1/80 | 0/80 |
| Event | PROPEL Mini Sinus Implant | PROPEL Nova Sinus Implant |
|---|---|---|
| acute sinusitisInfections and infestations | 12/80 | 16/80 |
| chronic sinusitisInfections and infestations | 9/80 | 4/80 |
| headacheNervous system disorders | 9/80 | 5/80 |
| asthmaRespiratory, thoracic and mediastinal disorders | 0/80 | 6/80 |
| upper respiratory tract infectionInfections and infestations | 5/80 | 4/80 |
| presyncopeNervous system disorders | 4/80 | 0/80 |
| epistaxisRespiratory, thoracic and mediastinal disorders | 4/80 | 1/80 |
This is an intra-patient design where one sinus side of the patient is randomized to receive the treatment while the contralateral sinus side acts as the control.
| Age, Continuous(years) | PROPEL Mini Sinus Implant and No Implant Cohort 1 | PROPEL Nova Sinus Implant and No Implant Cohort 2 | Total |
|---|---|---|---|
| Mean | 49.9 ± 13.91 | 49.5 ± 13.36 | 49.7 ± 13.6 |
| Sex: Female, Male(Participants) | PROPEL Mini Sinus Implant and No Implant Cohort 1 | PROPEL Nova Sinus Implant and No Implant Cohort 2 | Total |
|---|---|---|---|
| Female | 34 | 27 | 61 |
| Male | 46 | 53 | 99 |
| Ethnicity (NIH/OMB)(Participants) | PROPEL Mini Sinus Implant and No Implant Cohort 1 | PROPEL Nova Sinus Implant and No Implant Cohort 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 3 |
| Not Hispanic or Latino | 80 | 77 | 157 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | PROPEL Mini Sinus Implant and No Implant Cohort 1 | PROPEL Nova Sinus Implant and No Implant Cohort 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 2 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 9 | 21 |
| White | 62 | 68 | 130 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | PROPEL Mini Sinus Implant and No Implant Cohort 1 | PROPEL Nova Sinus Implant and No Implant Cohort 2 | Total |
|---|---|---|---|
| United States | 80 | 80 | 160 |
Plan to share: No
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Intersect ENT