Multi-Center Feasibility Study of Trans-oral Endoscopic Restrictive Implant System (TERIS) for Treatment of Obesity

NCT00707720 | Completed Phase 1

• 1 other identifier: BSI 07-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The Barosense Trans-oral Endoscopic Restrictive Implant System (TERIS) is an investigational system being evaluated for safety The system uses endoscopic guidance to trans-orally implant a restrictive reservoir for food entering the stomach in obese and morbidly obese subjects to induce early and prolonged satiety. The Intended Use of the system is for the treatment of obesity.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Adverse Events relating to the procedure and device

  6 months

Secondary Outcomes (1)

• Weight loss, Excess weight loss

  6 months

Study Arms (1)

TERIS procedure

EXPERIMENTAL

TERIS procedure for the treatment of obesity

Device: TERIS procedure

Interventions

TERIS procedure DEVICE

The implantation of the restrictive implant

TERIS procedure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All of the following criteria must be met for study participation/device implantation:
• Subject, male or female, is age 18 to 50 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 has a BMI of 40.0-49.0 or has a BMI of 35.0-39.9 plus one or more co-morbid diseases expected to improve with weight loss (e.g. hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus).
• Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
• Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator.
• Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study.
• Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination.
• 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.

You may not qualify if:

• A subject is ineligible to participate in this study if they meet any of the following criteria:
• Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
• Subject has an A1C ≥ 7.0%, or other indicator of poorly controlled diabetes.
• 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.
• 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.
• Subject has renal and/or hepatic insufficiency.
• Subject has thyroid disease which is not controlled with medication.
• Subject has a history of intestinal strictures or adhesions.
• Subject has systemic infection in the body at the time of TERIS procedure.
• Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to device implant), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
• Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis.
• 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.
• Subjects who are unable to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to a device implant or device removal procedure and continuing for 14 days post-procedure(s).
• Subjects undergoing chronic steroid therapy.

Sponsors & Collaborators

• BaroSense Inc.: lead

Study Sites (1)

Hopital Laval

Québec, Quebec, G1V4GS, Canada

Location

Related Publications (1)

• Biertho L, Hould FS, Lebel S, Biron S. Transoral endoscopic restrictive implant system: a new endoscopic technique for the treatment of obesity. Surg Obes Relat Dis. 2010 Mar 4;6(2):203-5. doi: 10.1016/j.soard.2009.08.006. Epub 2009 Aug 28. No abstract available.

  PMID: 19796996 DERIVED

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 Officials

• Kathy Stecco, MD

  Medical Consultant

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 1, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

CA (1)