Pancreatic Pseudocyst(s)NCT02146352

AXIOS Stent With Electrocautery Enhanced Delivery System

A study testing AXIOS Stent with Electrocautery Enhanced Delivery System in people with Pancreatic Pseudocyst(s), run by Xlumena, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pancreatic Pseudocyst(s)
What is being tested?: AXIOS Stent with Electrocautery Enhanced Delivery System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 8 sitesUnited States
Study dates: Jun 2014to Mar 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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≥70% fluid content
Patient understands the study requirements and the treatment procedures and provides written Informed Consent.
Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.

Who cannot join

The fluid collection to be drained is an immature pseudocyst
The fluid collection to be drained is a cystic neoplasm
The fluid collection to be drained is a pseudoaneurysm
The fluid collection to be drained is a duplication cyst
The fluid collection to be drained is a non-inflammatory fluid collection
There is more than one pseudocyst requiring drainage

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Abnormal coagulation:
INR > 1.5 and not correctable
presence of a bleeding disorder
platelets < 50,000/mm3
Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

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

Other trials in United States

About this study

Conditions: Pancreatic Pseudocyst(s)
Being tested: AXIOS Stent with Electrocautery Enhanced Delivery System
Keywords: Pancreatic pseudocyst
Medical subject headings: Pancreatic Pseudocyst

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AXIOS Stent with Electrocautery Enhanced Delivery SystemDevice
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.

Study groups in NCT02146352
Study group	Role	What they receive
Treatment	Experimental	AXIOS Stent with Electrocautery Enhanced Delivery System Receives: Device: AXIOS Stent with Electrocautery Enhanced Delivery System

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety/Adverse Event Outcome Measure 1
Freedom from access site-related bleeding requiring transfusion
Measured: Index procedure through 1-week post-stent removal
Safety/Adverse Event Outcome Measure 2
Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
Measured: Index procedure through 1-week post-stent removal
Safety/Adverse Event Outcome Measure 3
Freedom from surgery for access-site related perforation
Measured: Index procedure through 1-week post-stent removal
Safety/Adverse Event Outcome 4
Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen
Measured: Index procedure through 1-week post-stent removal
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
Measured: Index procedure through 1-week post-stent removal
Safety/Adverse Event Outcome Measure 6
Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure
Measured: Index procedure through 1-week post-stent removal

Secondary outcomes (5)

Stent Retention Outcome Measure
Stent Retention: The stent must remain in place for up to 60 days
Measured: 30 or 60 days post-procedure
Lumen Patency Outcome Measure
Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.
Measured: 30 and/or 60 days post-procedure
Technical Success Outcome Measure 1
Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System
Measured: Index Procedure
Clinical Success Outcome Measure
Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days
Measured: 30 or 60 days post-procedure
Technical Success Outcome Measure 2
Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps
Measured: 30 or 60 Day Post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Mar 2015

First posted23 May 2014 (estimated)
Study startJun 2014
Primary completionJan 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pancreatic Pseudocyst(s)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02146352
Sponsor's protocol ID: CP201303
Status last verified: Sep 2015
First submitted: 13 May 2014
Last updated: 2 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AXIOS Stent With Electrocautery Enhanced Delivery System
ClinicalTrials.gov ID: NCT02146352
Acronym / sponsor ID: CP201303
Conditions: Pancreatic Pseudocyst(s)
Keywords: Pancreatic pseudocyst
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Xlumena, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Jan 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 23 May 2014 (estimated)
Results: Posted 2 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Device: AXIOS Stent with Electrocautery Enhanced Delivery SystemAXIOS Stent with Electrocautery Enhanced Delivery System

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age between 18 and 75 years old, male or female
Eligible for endoscopic intervention
Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
Symptomatic pancreatic pseudocyst having the following characteristics:
Patient understands the study requirements and the treatment procedures and provides written Informed Consent.

Key exclusion criteria (15 listed)

The fluid collection to be drained is an immature pseudocyst
The fluid collection to be drained is a cystic neoplasm
The fluid collection to be drained is a pseudoaneurysm
The fluid collection to be drained is a duplication cyst
The fluid collection to be drained is a non-inflammatory fluid collection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AXIOS Stent with Electrocautery Enhanced Delivery SystemEndoscopy 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.	Device	Treatment

Primary outcome

Safety/Adverse Event Outcome Measure 1
Time frame: Index procedure through 1-week post-stent removal
Freedom from access site-related bleeding requiring transfusion
Safety/Adverse Event Outcome Measure 2
Time frame: Index procedure through 1-week post-stent removal
Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
Safety/Adverse Event Outcome Measure 3
Time frame: Index procedure through 1-week post-stent removal
Freedom from surgery for access-site related perforation
Safety/Adverse Event Outcome 4
Time frame: Index procedure through 1-week post-stent removal
Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen
Safety/Adverse Event Outcome Measure 5
Time frame: Index procedure through 1-week post-stent removal
Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal
Safety/Adverse Event Outcome Measure 6
Time frame: Index procedure through 1-week post-stent removal
Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure

5 secondary outcomes

Stent Retention Outcome Measure
Time frame: 30 or 60 days post-procedure
Lumen Patency Outcome Measure
Time frame: 30 and/or 60 days post-procedure
Technical Success Outcome Measure 1
Time frame: Index Procedure
Clinical Success Outcome Measure
Time frame: 30 or 60 days post-procedure
Technical Success Outcome Measure 2
Time frame: 30 or 60 Day Post-procedure

Results and safety

Results posted to the registry on 2 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	30	28

Primary outcome: Safety/Adverse Event Outcome Measure 1

Time frame: Index procedure through 1-week post-stent removal. Number. Unit: percentage of patients

Measure	Treatment n = 30
Value	100

Population analysed: Entire patient cohort

Primary outcome: Safety/Adverse Event Outcome Measure 2

Time frame: Index procedure through 1-week post-stent removal. Number. Unit: percentage of patients

Measure	Treatment n = 30
Value	100

Population analysed: Entire patient cohort

Primary outcome: Safety/Adverse Event Outcome Measure 3

Time frame: Index procedure through 1-week post-stent removal. Number. Unit: percentage of patients

Measure	Treatment n = 30
Value	100

Population analysed: Entire patient cohort

Primary outcome: Safety/Adverse Event Outcome 4

Time frame: Index procedure through 1-week post-stent removal. Number. Unit: percentage of patients

Measure	Treatment n = 28
Value	96.4

Population analysed: Patients for which AXIOS stent migration/dislodgement could be assessed

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Index procedure through 1-week post-stent removal. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	13 of 30 (43.3%)	10 of 30 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven A Edmundowicz, MD principal investigator

Washington University School of Medicine

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AXIOS Stent with Electrocautery Enhanced Delivery System in people with Pancreatic Pseudocyst(s), run by Xlumena, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety/Adverse Event Outcome Measure 1 (time frame: Index procedure through 1-week post-stent removal). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02146352.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.