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

NCT01388673 | Withdrawn

• 1 other identifier: Protocol 11-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obese

Keywords

prior RYGB procedure; regained weight over time; dilated pouch and/or stoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percent excess weight loss in participants relative to preop weight

  Through 12 months post-procedure

Study Arms (1)

ACE Stapler procedure

EXPERIMENTAL

ACE Stapler procedure for the treatment of dilated post-surgical gastric anatomy

Procedure: BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy

Interventions

BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy PROCEDURE

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.

ACE Stapler procedure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject, male or female, is age 18 to 60 years of age.
• Subject must be able to understand and be willing to sign an informed consent document.
• 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.
• Subject must be \> 2 years post RYGB surgery.
• 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.
• Subject has a BMI at baseline of \> 30 and \< 50.
• 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.
• Subject must have a stoma diameter of at least 18 mm.
• Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.

You may not qualify if:

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

Sponsors & Collaborators

• BaroSense Inc.: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 7, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 8, 2012

Record last verified: 2012-02