Clinical Trial: AXIOS Stent & Delivery System Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Multi-center, Non-blinded, Single-arm (Nonrandomized) Study of the AXIOS Stent and Delivery System
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 Summary:
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: pl
Sponsor: Xlumena, Inc.
Current Primary Outcome:
- Safety - Freedom From Major Complications: Access Site-related Bleeding [ Time Frame: Through the duration of the 1-week post-stent removal study period ]Subjects are free of access site-related bleeding requiring transfusion
- Safety - Freedom From Major Complications: Access Site-related Infection [ Time Frame: Through the duration of the 1-week post-stent removal study period ]Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
- Safety - Freedom From Major Complications: Perforation [ Time Frame: Through the duration of the 1-week post-stent removal study period ]Subjects are free of surgery for access-site related perforation
- Safety - Freedom From Major Complications: Stent Migration/Dislodement [ Time Frame: Through the duration of the 1-week post-stent removal study period ]Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen
- Safety - Freedom From Major Complications: Tissue Injury [ Time Frame: Through the duration of the 1-week post-stent removal study period ]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 [ Time Frame: Through the duration of the 1-week post-stent removal study period ]
- Absence of access site-related bleeding requiring transfusion
- Absence of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
- Absence of tissue injury, defined as ulceration to the submucosa at the site of stent implant.
- No surgery for access-site related perforation required
- No stent migration/dislodgement into the pseudocyst or enteral lumen.
- No serious adverse event classified as implant-associated or implant/surgical procedure-associated;
Current Secondary Outcome:
- Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days [ Time Frame: Up to 60 days ]Stent lumen patency at 30 days and/or 60 days.
- Effectiveness: Stent Removability at 30 Days and/or 60 Days [ Time Frame: Up to 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 [ Time Frame: Up to 60 days ]Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare.
- Clinical Success [ Time Frame: Up to 60 days ]Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.
Original Secondary Outcome: Effectiveness [ Time Frame: @ 30 days and/or 60 days post-procedure follow-up ]
- Stent lumen patency at 30 days and/or 60 days.
- Stent removability at 30 days and/or 60 days.
- Technical Success: Successful placement of the AXIOS stent using the AXIOS delivery system and successful removal of the AXIOS stent using a standard endoscopic snare.
- Clinical Success: At least 50% decrease in pseudocyst size, based on radiographic analysis at 30 days and/or 60 days.
Information By: Xlumena, Inc.
Dates:
Date Received: August 15, 2011
Date Started: August 2011
Date Completion:
Last Updated: September 2, 2015
Last Verified: September 2015
- Safety - Freedom From Major Complications: Access Site-related Bleeding [ Time Frame: Through the duration of the 1-week post-stent removal study period ]
