The ACE Follow-up Study
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)."|
- Safety [ Time Frame: Enrollment through 24 months post-procedure. ] [ Designated as safety issue: Yes ]
The primary safety analysis will assess the occurrence and procedure relatedness of the following events:
- Adverse Events (AE)
- Adverse Device Effects (ADE)
- Serious Adverse Events (SAE)
- Unanticipated Adverse Device Effects (UADE)
- Percent excess weight loss [ Time Frame: Procedure through 24 months post-procedure ] [ Designated as safety issue: No ]
Percent excess weight loss (%EWL), defined as: (preoperative weight-current weight)/(preoperative weight - ideal weight) *100, where ideal weight is the weight that would correspond to a BMI of 25 based on the subject's height.
Relative to weight at the procedure visit.
- Total weight lost (kg) and percent weight lost [ Time Frame: Procedure through 24 months post-procedure ] [ Designated as safety issue: No ]Relative to weight at the procedure visit.
- Change in Body Mass Index (BMI) and percent change in BMI [ Time Frame: Procedure through 24 months post-procedure ] [ Designated as safety issue: No ]Relative to BMI at the procedure visit.
- Change in waist circumference [ Time Frame: Procedure through 24 months post-procedure ] [ Designated as safety issue: No ]Relative to to waist circumference at the procedure visit.
- Improvement in co-morbid disease(s) [ Time Frame: Enrollment through 24 months post-procedure ] [ Designated as safety issue: No ]Including but not limited to, improvement in vital signs and/or laboratory values.
- Changes in Quality of Life [ Time Frame: Enrollment through 24 months post-procedure ] [ Designated as safety issue: No ]As reported on the SF-36 Quality of LIfe Questionnaire.
- Changes in Feelings of Satiety [ Time Frame: Enrollment through 24 months post-procedure ] [ Designated as safety issue: No ]As reported on the TFEQ-R18 Three Factor Eating Questionnaire.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: ACE procedure
ACE procedure for the treatment of obesity
Procedure: ACE Stapler
The ACE Stapler is used endoscopically, and incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach.
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 BaroSense's 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429194
|Hospital Aleman / Programa de Unidades Bariátricas|
|Autonoma de Bueno Aires, Argentina, CP 1118|
|Hospital Italiano de Mendoza / Clinica Quirugica S. A.|
|Mendoza, Argentina, 290|
|University Institute of Cardiology and Pulmonary Medicine of Quebec|
|Quebec, Canada, G1V 4G5|
|Tel-Aviv Sourasky Medical Center|
|Tel-Aviv, Israel, 64234|
|Amsterdam Medical Center|
|Amsterdam, Netherlands, 110AZ|
|University Hospital Maastricht|
|Maastricht, Netherlands, 6202|
|Principal Investigator:||Simon Biron, MD||University Institute of Cardiology and Pulmonary Medicine of Quebec|