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CompletedNCT02146352Updated Oct 2, 2015Results posted

AXIOS Stent With Electrocautery Enhanced Delivery System

An interventional study of AXIOS Stent with Electrocautery Enhanced Delivery System in Pancreatic Pseudocyst(s), sponsored by Xlumena, Inc.. Completed at 8 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-10-02.

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

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of pancreatic pseudocysts.

02

Conditions studied

  • Pancreatic Pseudocyst(s)

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Keywords

  • Pancreatic pseudocyst
03

In context

Pancreatic Pseudocyst

30 studies on the registry are indexed under Pancreatic Pseudocyst; 9 are open to participants now.

This study's enrollment of 30 is below the median of 45 across 21 interventional studies indexed under Pancreatic Pseudocyst.

Browse Pancreatic Pseudocyst studies →

Lead sponsor

Xlumena, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age between 18 and 75 years old, male or female
  2. Eligible for endoscopic intervention
  3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage

  4. Symptomatic pancreatic pseudocyst having the following characteristics:

    • Greater or equal to 6 cm in diameter (based upon the maximum cross-sectional area in the CT scan or transabdominal ultrasound).
    • Adherent to bowel wall, and
    • ≥70% fluid content
  5. Patient understands the study requirements and the treatment procedures and provides written Informed Consent.
  6. Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.

Exclusion criteria

Exclusion Criteria:

  1. The fluid collection to be drained is an immature pseudocyst
  2. The fluid collection to be drained is a cystic neoplasm
  3. The fluid collection to be drained is a pseudoaneurysm
  4. The fluid collection to be drained is a duplication cyst
  5. The fluid collection to be drained is a non-inflammatory fluid collection
  6. There is more than one pseudocyst requiring drainage

  7. Abnormal coagulation:

    • INR > 1.5 and not correctable
    • presence of a bleeding disorder
    • platelets \< 50,000/mm3
  8. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
  9. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
  10. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
  11. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
  12. Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
05

Study design

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

Study arms

  • Experimental
    Treatment

    AXIOS Stent with Electrocautery Enhanced Delivery System

    Device: AXIOS Stent with Electrocautery Enhanced Delivery System

Interventions

  • DeviceAXIOS Stent with Electrocautery Enhanced Delivery System

    Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.

06

What researchers measure

Primary outcomes

  1. Safety/Adverse Event Outcome Measure 1

    Freedom from access site-related bleeding requiring transfusion

    Time frame: Index procedure through 1-week post-stent removal

  2. Safety/Adverse Event Outcome Measure 2

    Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization

    Time frame: Index procedure through 1-week post-stent removal

  3. Safety/Adverse Event Outcome Measure 3

    Freedom from surgery for access-site related perforation

    Time frame: Index procedure through 1-week post-stent removal

  4. Safety/Adverse Event Outcome 4

    Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen

    Time frame: Index procedure through 1-week post-stent removal

  5. Safety/Adverse Event Outcome Measure 5

    Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal

    Time frame: Index procedure through 1-week post-stent removal

  6. Safety/Adverse Event Outcome Measure 6

    Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure

    Time frame: Index procedure through 1-week post-stent removal

Secondary outcomes

  1. Stent Retention Outcome Measure

    Stent Retention: The stent must remain in place for up to 60 days

    Time frame: 30 or 60 days post-procedure

  2. Lumen Patency Outcome Measure

    Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.

    Time frame: 30 and/or 60 days post-procedure

  3. Technical Success Outcome Measure 1

    Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System

    Time frame: Index Procedure

  4. Clinical Success Outcome Measure

    Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days

    Time frame: 30 or 60 days post-procedure

  5. Technical Success Outcome Measure 2

    Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps

    Time frame: 30 or 60 Day Post-procedure

07

Results

Posted Oct 2, 2015

Participant flow

Participant flow — Overall Study
MilestoneTreatment
Started30
30 or 60 days post-procedure30
7 days post-stent removal28
Completed28
Not completed2
Withdrew: Death1
Withdrew: Patient entered hospice care1

Outcome measures

PrimarySafety/Adverse Event Outcome Measure 1

Freedom from access site-related bleeding requiring transfusion

Time frame:
Index procedure through 1-week post-stent removal
Reported as:
Number · percentage of patients
Safety/Adverse Event Outcome Measure 1
percentage of patientsTreatment
Safety/Adverse Event Outcome Measure 1100
SecondaryStent Retention Outcome Measure

Stent Retention: The stent must remain in place for up to 60 days

Time frame:
30 or 60 days post-procedure
Reported as:
Number · percentage of patients
Stent Retention Outcome Measure
percentage of patientsTreatment
Stent Retention Outcome Measure100
SecondaryLumen Patency Outcome Measure

Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.

Time frame:
30 and/or 60 days post-procedure
Reported as:
Number · percentage of patients
Lumen Patency Outcome Measure
percentage of patientsTreatment
Lumen Patency Outcome Measure86.7
SecondaryTechnical Success Outcome Measure 1

Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System

Time frame:
Index Procedure
Reported as:
Number · percentage of patients
Technical Success Outcome Measure 1
percentage of patientsTreatment
Technical Success Outcome Measure 1100
SecondaryClinical Success Outcome Measure

Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days

Time frame:
30 or 60 days post-procedure
Reported as:
Number · percentage of patients
Clinical Success Outcome Measure
percentage of patientsTreatment
Clinical Success Outcome Measure83.3
PrimarySafety/Adverse Event Outcome Measure 2

Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization

Time frame:
Index procedure through 1-week post-stent removal
Reported as:
Number · percentage of patients
Safety/Adverse Event Outcome Measure 2
percentage of patientsTreatment
Safety/Adverse Event Outcome Measure 2100
PrimarySafety/Adverse Event Outcome Measure 3

Freedom from surgery for access-site related perforation

Time frame:
Index procedure through 1-week post-stent removal
Reported as:
Number · percentage of patients
Safety/Adverse Event Outcome Measure 3
percentage of patientsTreatment
Safety/Adverse Event Outcome Measure 3100
PrimarySafety/Adverse Event Outcome 4

Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen

Time frame:
Index procedure through 1-week post-stent removal
Reported as:
Number · percentage of patients
Safety/Adverse Event Outcome 4
percentage of patientsTreatment
Safety/Adverse Event Outcome 496.4
PrimarySafety/Adverse Event Outcome Measure 5

Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal

Time frame:
Index procedure through 1-week post-stent removal
Reported as:
Number · percentage of patients
Safety/Adverse Event Outcome Measure 5
percentage of patientsTreatment
Safety/Adverse Event Outcome Measure 5100
PrimarySafety/Adverse Event Outcome Measure 6

Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure

Time frame:
Index procedure through 1-week post-stent removal
Reported as:
Number · percentage of patients
Safety/Adverse Event Outcome Measure 6
percentage of patientsTreatment
Safety/Adverse Event Outcome Measure 693.3
SecondaryTechnical Success Outcome Measure 2

Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps

Time frame:
30 or 60 Day Post-procedure
Reported as:
Number · percentage of patients
Technical Success Outcome Measure 2
percentage of patientsTreatment
Technical Success Outcome Measure 2100

Adverse events

Collected over Index procedure through 1-week post-stent removal. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment—13/30 (43.3%)10/30 (33.3%)
Most frequent serious events
Most frequent serious events
EventTreatment
PancreatitisGastrointestinal disorders9/30
BronchitisInfections and infestations1/30
Biliary StrictureHepatobiliary disorders1/30
Bleeding post-AXIOS stent removalSurgical and medical procedures1/30
CellulitisInfections and infestations1/30
Pleural EffusionRespiratory, thoracic and mediastinal disorders1/30
SepsisInfections and infestations1/30
Chest pain/shortness of breathCardiac disorders1/30
Most frequent other events
Showing 10 of 14
Most frequent other events
EventTreatment
Abdominal PainGastrointestinal disorders3/30
Pancreatic duct leakEndocrine disorders2/30
AscitesGastrointestinal disorders1/30
Bleeding post-AXIOS stent removalSurgical and medical procedures1/30
Blood in urineRenal and urinary disorders1/30
Chest painCardiac disorders1/30
ConcussionInjury, poisoning and procedural complications1/30
FeverInfections and infestations1/30
Lightheadedness/ dizzinessGeneral disorders1/30
NauseaGastrointestinal disorders1/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment
Mean52.0 ± 14.9
Sex: Female, Male
Sex: Female, Male(Participants)Treatment
Female13
Male17
Region of Enrollment
Region of Enrollment(participants)Treatment
United States30
Height
Height(inches)Treatment
Mean67.3 ± 4.3
Weight
Weight(pounds)Treatment
Mean172.9 ± 36.8
08

Study locations

8 sites
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
  • Baptist Medical Center
    Jacksonville, Florida 32256, United States
  • Florida Hospital
    Orlando, Florida 32803, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
  • Washington University in St. Louis
    St. Louis, Missouri 63110, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02146352
Lead sponsor
Xlumena, Inc.
Responsible party
Sponsor
First posted
May 23, 2014
Start date
Jun 2014
Primary completion
Jan 2015
Completion
Mar 2015
Results posted
Oct 2, 2015
Last update
Oct 2, 2015

Study contacts

Steven A Edmundowicz, MD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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