Open prospective study to evaluate the safety and preliminary effectiveness of the BaroSense ACE(TM) Stapler for plication of dilated post-surgical gastric anatomy

Withdrawn

Conditions: gastric bypass requiring revision
Obesity
10017998

Registration Number: NL-OMON35914

Lead Sponsor: BaroSense Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

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. (for this protocol)
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 (at the site the jejunum attaches to the pouch).
9.Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
10.Subject can undergo general anesthesia, as evaluated by the Principal Investigator.
11.Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator.
12.Subject*s general practitioner will be informed about the subject*s participation in this study. 13.Subject agrees to refrain from any type of reconstructive surgery that may affect body weight such as mammoplasty or abdominal lipoplasty or liposuction, during the trial.
14.Subject agrees to follow the post procedure aftercare program.

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.
10.Subject has significant esophageal disease including Zenker*s diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett*s esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility.
11.Subject has renal and/or hepatic insufficiency.
12.Subject has thyroid disease which is not controlled with medication.
13.Subject has a history of intestinal strictures or adhesions.
14.Subject has systemic infection in the body at the time of procedure.
15.Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to the procedure), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
16.Female subject who started birth control pills less than 3 months before enrollment, or who plans to start taking birth control pills during the study
17.Subject has had previous esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis.
18.Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation.
19.Subject is observed at baseline EGD to have malignant or poor quality/friable tissue in areas where the plications are likely to be placed.
20.Subjects who are unable to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to a procedure and continuing for 14 days post-procedure.
21.Subjects undergoing chronic steroid therapy.
22.Subjects undergoing immunosuppressive therapy.
23.Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the procedure as well as during the trial period.
24.Subjects who have cardiac pacemakers or other electronic implantable devices.
25.Subjects who have hiatal hernias greater than 2 cm.
26.Subjects who have current or potential neck masses that in the opinion of the investigator, may interfere with study-related procedures, or who have a Mallampati (intubation) score greater than 3.
27.Subjects who have poorly controlled psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>All subjects for whom the dilated tissue procedure is initiated (defined as<br /><br>introduction of the ACE stapler and the attempt made, whether or not<br /><br>successful, to place a plication) will be included in the safety analysis.<br /><br>Subjects for whom the dilated tissue procedure with the ACE Stapler was<br /><br>completed (defined as at least 1 plication formed) will be included in the<br /><br>intent to treat population.<br /><br>The primary safety analysis will assess the occurrence of adverse events<br /><br>through 12 months following procedures. Included in this assessment will be the<br /><br>proportion of subjects with any of the following outcomes between enrollment<br /><br>and completion of the 12 month follow-up evaluation: Adverse Events (AE),<br /><br>Adverse Device Effects (ADE), Serious Adverse Events (SAE) and Unanticipated<br /><br>Adverse Device Effects (UADE). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Efficacy<br /><br>Efficacy outcome measures (variables) will be analyzed relative to the surgery<br /><br>visit and include:<br /><br>• Percent of plications still visible at the 12 month endoscopy<br /><br>• Percent Excess Weight Loss (%EWL) defined as: (preop weight-current<br /><br>weight)/(preop weight - ideal weight) 100, where ideal weight is calculated<br /><br>from a BMI of 25 based on the subjects height.<br /><br>• Total weight lost (kg)<br /><br>• Change in body mass index (BMI)<br /><br>• Change in waist circumference<br /><br>• Improvement in co-morbid disease(s) including, but not limited to,<br /><br>improvement in vital signs and/or laboratory values<br /><br>• Improvement of dumping syndrome for subjects who have this complication post<br /><br>RYGB<br /><br>• Improvement in quality of life as indicated by the SF-36 Quality of Life<br /><br>questionnaire evaluated relative to baseline</p><br>