Back to resultsAXIOS Stent & Delivery System Study
Primary Purpose
Pancreatic Pseudocyst(s)
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AXIOS Stent & Delivery System
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Pseudocyst(s) focused on measuring symptomatic pancreatic pseudocyst, pancreatic pseudocyst, transluminal drainage, minimally invasive, Nitinol stent, transmural endoscopic drainage, catheter based
Eligibility Criteria
Inclusion Criteria:
(patients must meet all criteria)
- 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 than or equal to 6 cm in size (based upon the maximum crosssectional area in the CT scan),
- Adherent to bowel wall, and
- ≥70% fluid content
- Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.
- Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.
Exclusion Criteria:
(patients meeting any of the below criteria will be excluded from study)
- <18 or >75 years of age
Pancreatic pseudocysts having the following characteristics:
- Require nasocystic drainage,
- < 69% fluid content
- 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
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.
Sites / Locations
- California Pacific Medical Center (CPMC)
- Unversity of Colorado Denver
- Borland-Groover Clinic
- University of Chicago Medical Center (UCMC)
- Cornell University
- Thomas Jefferson University
- Hospital Costa del Sol
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AXIOS Stent and Delivery System
Arm Description
Outcomes
Primary Outcome Measures
Safety - Freedom From Major Complications: Access Site-related Bleeding
Subjects are free of access site-related bleeding requiring transfusion
Safety - Freedom From Major Complications: Access Site-related Infection
Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
Safety - Freedom From Major Complications: Perforation
Subjects are free of surgery for access-site related perforation
Safety - Freedom From Major Complications: Stent Migration/Dislodement
Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen
Safety - Freedom From Major Complications: Tissue Injury
Subjects are free of tissue injury (ulceration to the submucosa) at stent site persisting through 1-week post-stent removal.
Safety - Freedom From Major Complications: SAE's
Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated.
Secondary Outcome Measures
Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days
Stent lumen patency at 30 days and/or 60 days.
Effectiveness: Stent Removability at 30 Days and/or 60 Days
AXIOS stent removal was indicated at the time of pseudocyst resolution (≤ 3 cm diameter) or at 60 the day post procedure visit. Scheduled examination for pseudocyst resolution was designated at 30 days for removal if the pseudocyst resolution criterion was met. Otherwise, the stent was left in place for removal at the 60 day visit.
Effectiveness: Technical Success
Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare.
Clinical Success
Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01419769
Brief Title
AXIOS Stent & Delivery System Study
Official Title
A Prospective, Multi-center, Non-blinded, Single-arm (Nonrandomized) Study of the AXIOS Stent and Delivery System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xlumena, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA).
The study design is prospective, multi-center, non-blinded, single-arm (nonrandomized) study. Up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients will be followed at (approximately) 30 days and/or 60 days depending upon pseudocyst resolution confirmation, at 1-week post-stent removal,and possibly at 3 and 6 month post-stent removal.
Detailed Description
OBJECTIVE:
To demonstrate the safety and effectiveness of the Xlumena AXIOS Stent and Delivery System for endoscopic drainage of pancreatic pseudocysts in patients with symptomatic pancreatic pseudocysts that are greater than or equal to 6 cm (≥6cm) in diameter, have ≥ 70% fluid contents and are adherent to the bowel wall.
STUDY DESIGN:
Prospective, multi-center, non-blinded, single-arm (nonrandomized) study
KEY ENDPOINTS:
Safety: The safety endpoint is freedom from major complications through the duration of the 1-week post-stent removal study period, defined as:
Access site-related bleeding requiring transfusion;
Access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization;
Surgery for access-site related perforation;
Stent migration/dislodgement into the pseudocyst or enteral lumen;
Tissue injury, defined as ulceration to the submucosa at site of stent implant as observed to persist through 1-week post-stent removal.
Serious adverse event classified as implant-associated or implant/endoscopic procedure-associated;
Effectiveness:
Stent lumen patency at 30 days and/or 60 days
Stent removability at 30 days and/ or 60 days.
Technical success, defined as: placement of the AXIOS stent using the AXIOS delivery system and removal of the AXIOS stent using a standard endoscopic snare.
Clinical success, defined as: at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.
PATIENT POPULATION:
Patients between 18 and 75 years of age, suitable for transluminal drainage of symptomatic pancreatic pseudocysts that are greater than or equal to 6 cm in diameter and adherent to the bowel wall are candidates for study treatment.
FOLLOW-UP SCHEDULE:
Clinical follow-up evaluations of study endpoints will be conducted at 30 days and/or 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
PLANNED NUMBER OF PATIENTS, SITES & REGIONS:
The target enrollment for the study is 24 subjects. Study will be conducted at up to 10 investigational sites in the United States, Japan and/or the European Community. A majority of the patients will be enrolled in the United States.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Pseudocyst(s)
Keywords
symptomatic pancreatic pseudocyst, pancreatic pseudocyst, transluminal drainage, minimally invasive, Nitinol stent, transmural endoscopic drainage, catheter based
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AXIOS Stent and Delivery System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AXIOS Stent & Delivery System
Intervention Description
The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
Primary Outcome Measure Information:
Title
Safety - Freedom From Major Complications: Access Site-related Bleeding
Description
Subjects are free of access site-related bleeding requiring transfusion
Time Frame
Through the duration of the 1-week post-stent removal study period
Title
Safety - Freedom From Major Complications: Access Site-related Infection
Description
Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
Time Frame
Through the duration of the 1-week post-stent removal study period
Title
Safety - Freedom From Major Complications: Perforation
Description
Subjects are free of surgery for access-site related perforation
Time Frame
Through the duration of the 1-week post-stent removal study period
Title
Safety - Freedom From Major Complications: Stent Migration/Dislodement
Description
Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen
Time Frame
Through the duration of the 1-week post-stent removal study period
Title
Safety - Freedom From Major Complications: Tissue Injury
Description
Subjects are free of tissue injury (ulceration to the submucosa) at stent site persisting through 1-week post-stent removal.
Time Frame
Through the duration of the 1-week post-stent removal study period
Title
Safety - Freedom From Major Complications: SAE's
Description
Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated.
Time Frame
Through the duration of the 1-week post-stent removal study period
Secondary Outcome Measure Information:
Title
Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days
Description
Stent lumen patency at 30 days and/or 60 days.
Time Frame
Up to 60 days
Title
Effectiveness: Stent Removability at 30 Days and/or 60 Days
Description
AXIOS stent removal was indicated at the time of pseudocyst resolution (≤ 3 cm diameter) or at 60 the day post procedure visit. Scheduled examination for pseudocyst resolution was designated at 30 days for removal if the pseudocyst resolution criterion was met. Otherwise, the stent was left in place for removal at the 60 day visit.
Time Frame
Up to 60 days
Title
Effectiveness: Technical Success
Description
Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare.
Time Frame
Up to 60 days
Title
Clinical Success
Description
Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.
Time Frame
Up to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(patients must meet all criteria)
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 than or equal to 6 cm in size (based upon the maximum crosssectional area in the CT scan),
Adherent to bowel wall, and
≥70% fluid content
Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.
Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.
Exclusion Criteria:
(patients meeting any of the below criteria will be excluded from study)
<18 or >75 years of age
Pancreatic pseudocysts having the following characteristics:
Require nasocystic drainage,
< 69% fluid content
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
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.
Facility Information:
Facility Name
California Pacific Medical Center (CPMC)
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Unversity of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
University of Chicago Medical Center (UCMC)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Hospital Costa del Sol
City
Marbella
ZIP/Postal Code
951976669
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25290534
Citation
Shah RJ, Shah JN, Waxman I, Kowalski TE, Sanchez-Yague A, Nieto J, Brauer BC, Gaidhane M, Kahaleh M. Safety and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with lumen-apposing covered self-expanding metal stents. Clin Gastroenterol Hepatol. 2015 Apr;13(4):747-52. doi: 10.1016/j.cgh.2014.09.047. Epub 2014 Oct 5.
Results Reference
derived
Links:
URL
http://www.xlumena.com/
Description
click here for more information about the Sponsor
Learn more about this trial
AXIOS Stent & Delivery System Study
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