Safety and Preliminary Effectiveness of the BaroSense Articulating Circular Endoscopic (ACE) Stapler for Plication of Dilated Post-surgical Gastric Anatomy

Open Prospective Study to Evaluate the Safety and Preliminary Effectiveness of the BaroSense ACE Stapler for Plication of Dilated Post-surgical Gastric Anatomy

The BaroSense Articulating Circular Endoscopic (ACE) Stapler is an investigational instrument indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract. This study explores the specific application of tissue apposition in dilated post-surgical gastric anatomy such as observed in a dilated Roux-en-Y Gastric Bypass (RYGB) pouch.

The primary objective of this study is to perform an evaluation of the safety of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy.

The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy over a 12 month follow-up period.

Study Overview

• Status: Withdrawn
• Conditions: Obese
• Intervention / Treatment: Procedure: BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject, male or female, is age 18 to 60 years of age.
2. Subject must be able to understand and be willing to sign an informed consent document.
3. Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
4. Subject must be > 2 years post RYGB surgery.
5. Subject must have documented records indicating an initial achievement of > 60% EWL (based on an ideal weight of 25 BMI) at some point after RYGB surgery.
6. Subject has a BMI at baseline of > 30 and < 50.
7. At time of enrollment, subject must have regained at least 35% of the maximum weight lost following RYGB, and the weight regain must have occurred over a period of not less than 3 months from the point of maximum weight loss.
8. Subject must have a stoma diameter of at least 18 mm.
9. Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.

Exclusion Criteria:

1. Subject has a severe eating disorder.
2. Investigator determines that there is another causal factor for the subject's weight regain other than dilated gastric anatomy.
3. Subject has previously undergone an endoscopic or surgical repair of dilated pouch or stoma (including sclerotherapy treatments).
4. Subject had irreversible or life threatening complications following initial RYGB procedure (cardio or respiratory).
5. Subject has an ongoing severe complication from their initial RYGB procedure (recurrent ventral hernia, pain syndrome, etc.).
6. Subject has an intragastric fistula, anastomotic leak, or staple/suture line disruption.
7. Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
8. Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
9. Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACE Stapler procedure; ACE Stapler procedure for the treatment of dilated post-surgical gastric anatomy	Procedure: BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy; The ACE Stapler is used endoscopically, an incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with adverse events	The primary safety analysis will assess the occurrence of adverse events through 12 months following procedures. Included in this assessment will be the proportion of subjects with any of the following outcomes between enrollment and completion of the 12 month follow-up evaluation: Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).	Post-procedure through 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent excess weight loss in participants relative to preop weight	Efficacy measurements will be analyzed relative to the surgery visit. The collected measures will include: Percent Excess Weight Loss (%EWL) defined as: (preop weight-current weight)/ (preop weight - ideal weight) *100, where ideal weight is calculated from a BMI of 25 based on the subject's height.; Total weight lost (kg); Change in body mass index (BMI); Change in waist circumference; Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values	Through 12 months post-procedure

Collaborators and Investigators

• Sponsor: BaroSense Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): February 1, 2013

Study Registration Dates

• First Submitted: July 1, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 7, 2011

Study Record Updates

• Last Update Posted (Estimate): February 8, 2012
• Last Update Submitted That Met QC Criteria: February 7, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: prior RYGB procedure; regained weight over time; dilated pouch and/or stoma
• Other Study ID Numbers: Protocol 11-02