Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01429194
Status:
COMPLETED
Last Update Posted:
2015-06-16
First Post:
2011-09-02
Brief Title:
The ACE Follow-up Study
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Continuation of Follow-up for Patients Who Were Previously Enrolled in the Clinical Study Open Prospective Study to Evaluate the Safety and Preliminary Effectiveness of the BaroSense ACE Stapler for the Treatment of Obesity - Protocol 11-03
Status:
COMPLETED
Status Verified Date:
2015-06
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 Articulating Circular Endoscopic ACE Stapler is an investigational system using endoscopic guidance to trans-orally place plications in the stomach in obese subjects to reduce volume and expansion of the fundus and greater curve to abate hunger as part of a supervised weight reduction program
The primary objective of this study is to perform an evaluation of the safety of the plication procedure
The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of obesity over a 24 month follow-up period
The primary objective of this study is to perform an evaluation of the safety of the plication procedure
The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of obesity over a 24 month follow-up period
Detailed Description:
This study was originally sponsored by BaroSense Inc protocol 11-03 69 subjects were enrolled and treated as part of the study at 6 centers in 4 countries outside the United States On April 30 2013 BaroSense Inc went out of business and the study was terminated with all participating centers Ethics Committees At the point of study termination all patients were in the middle of post procedure follow-up
Boston Scientific has since acquired the technology and study and will re-initiate follow-up to 24 months in order to collect data to support the original safety and efficacy endpoints of the protocol Only the 69 subjects previously enrolled and treated in BaroSenses protocol 11-03 will be eligible for participation in the Boston Scientific continued follow-up study The ACE Follow-up Study protocol 90891629 The Boston Scientific protocol will be approved by participating centers Ethics Committees and patients who choose to participate in The ACE Follow-up Study will need to sign a new Ethics Committee Approved informed consent form
Boston Scientific has since acquired the technology and study and will re-initiate follow-up to 24 months in order to collect data to support the original safety and efficacy endpoints of the protocol Only the 69 subjects previously enrolled and treated in BaroSenses protocol 11-03 will be eligible for participation in the Boston Scientific continued follow-up study The ACE Follow-up Study protocol 90891629 The Boston Scientific protocol will be approved by participating centers Ethics Committees and patients who choose to participate in The ACE Follow-up Study will need to sign a new Ethics Committee Approved informed consent form
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 90891629 | OTHER | Boston Scientific Corporation | None |