Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT01419769
Status:
COMPLETED
Last Update Posted:
2015-09-21
First Post:
2011-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
AXIOS Stent & Delivery System Study
Sponsor:
Xlumena, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multi-center, Non-blinded, Single-arm (Nonrandomized) Study of the AXIOS Stent and Delivery System
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
1. Access site-related bleeding requiring transfusion;
2. Access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization;
3. Surgery for access-site related perforation;
4. Stent migration/dislodgement into the pseudocyst or enteral lumen;
5. Tissue injury, defined as ulceration to the submucosa at site of stent implant as observed to persist through 1-week post-stent removal.
6. Serious adverse event classified as implant-associated or implant/endoscopic procedure-associated;
Effectiveness:
1. Stent lumen patency at 30 days and/or 60 days
2. Stent removability at 30 days and/ or 60 days.
3. 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.
4. 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.
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:
1. Access site-related bleeding requiring transfusion;
2. Access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization;
3. Surgery for access-site related perforation;
4. Stent migration/dislodgement into the pseudocyst or enteral lumen;
5. Tissue injury, defined as ulceration to the submucosa at site of stent implant as observed to persist through 1-week post-stent removal.
6. Serious adverse event classified as implant-associated or implant/endoscopic procedure-associated;
Effectiveness:
1. Stent lumen patency at 30 days and/or 60 days
2. Stent removability at 30 days and/ or 60 days.
3. 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.
4. 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: