An interventional study of ACE Stapler in Obesity, sponsored by Boston Scientific Corporation. Completed at 6 sites in 4 countries. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-06-16.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 69 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Safety
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)
Time frame: Enrollment through 24 months post-procedure.
Percent excess weight loss
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.
Time frame: Procedure through 24 months post-procedure
Total weight lost (kg) and percent weight lost
Relative to weight at the procedure visit.
Time frame: Procedure through 24 months post-procedure
Change in Body Mass Index (BMI) and percent change in BMI
Relative to BMI at the procedure visit.
Time frame: Procedure through 24 months post-procedure
Change in waist circumference
Relative to to waist circumference at the procedure visit.
Time frame: Procedure through 24 months post-procedure
Improvement in co-morbid disease(s)
Including but not limited to, improvement in vital signs and/or laboratory values.
Time frame: Enrollment through 24 months post-procedure
Changes in Quality of Life
As reported on the SF-36 Quality of LIfe Questionnaire.
Time frame: Enrollment through 24 months post-procedure
Changes in Feelings of Satiety
As reported on the TFEQ-R18 Three Factor Eating Questionnaire.
Time frame: Enrollment through 24 months post-procedure
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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