Endoscopic Bariatric Stapling Pilot Study

NCT01067625 | Unknown Phase 1

• 1 other identifier: TR-0009 Rev F
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief Summary

This study is a prospective single-arm, multicenter study to evaluate the safety and effectiveness of the TOGA® Procedure for the treatment of morbid obesity.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Percent excess weight loss (%EWL)

  up to 60 months

• Adverse events, including serious adverse events, will be recorded to determine safety

  up to 60 months

Secondary Outcomes (2)

• Improvement in Co-morbidities

  up to 60 months

• Improvements in other Obesity Measures and Change in Quality Of Life Measures

  up to 60 months

Study Arms (1)

TOGA subjects

EXPERIMENTAL

Device: TOGA® System

Interventions

TOGA® System DEVICE

Formation of restrictive sleeve via transoral gastric stapling for treatment of obesity

TOGA subjects

Eligibility Criteria

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

You may qualify if:

• Age 18 years - 60 years
• Eligible for bariatric surgery per US National Institute of Health (NIH) guidelines BMI ≥ 40 kg/m2 and \< 55 kg/m2, or BMI ≥ 35 kg/m2 with one or more comorbidities. Comorbidities are defined as diabetes, pulmonary disease, cardiac disease, or hypertension \[systolic blood pressure of ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg (or both) or on treatment for hypertension\]
• History of obesity for at least 2.5 years
• History of failure with non-surgical weight loss methods.
• Agree to comply with the substantial dietary restrictions required by the procedure.
• Understands risks of procedures, agree to follow protocol requirements, including signing informed consent, returning for follow-up visits and completing all required testing, completing diet and behavior modification counseling.

You may not qualify if:

• Patient history of inflammatory disease of the gastrointestinal tract including Crohn's disease or ulcerative colitis.
• Significant known esophageal disease including grade 3-4 esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, nutcracker esophagus, achalasia, esophageal dysmotility.
• Severe coagulopathy, upper GI bleeding conditions such as esophageal or gastric varices, congenital or acquired telangiectasia.
• Congenital or acquired anomalies of the GI tract such as atresias or stenoses.
• Hiatal hernia ≥2cm
• Severe cardiopulmonary disease or other serious organic disease including HIV or cancer.
• Currently pregnant or nursing. Potentially childbearing (i.e not post-menopausal or surgically sterilized) and not willing to use an effective method of contraception for the next 12 months.
• Current alcohol or drug addiction.
• Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator or psychologist/psychiatrist, make the subject a poor candidate for this procedure.
• Previous gastric, esophageal, pancreatic, or bariatric surgery.
• Infection anywhere in the body at the time of the procedure.
• Patient history of scleroderma.
• Thyroid disease which is not controlled with medication.
• Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
• Known active H-pylori infection.

Sponsors & Collaborators

• Satiety, Inc.: lead

Study Sites (2)

ULB (Universite Libre de Bruxelles) - Erasme Hospital

Brussels, 1070, Belgium

Location

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Rome, Italy

Location

Related Publications (1)

• Familiari P, Costamagna G, Blero D, Le Moine O, Perri V, Boskoski I, Coppens E, Barea M, Iaconelli A, Mingrone G, Moreno C, Deviere J. Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome. Gastrointest Endosc. 2011 Dec;74(6):1248-58. doi: 10.1016/j.gie.2011.08.046.

  PMID: 22136774 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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 11, 2010
• Study Start: February 1, 2006
• Primary Completion: December 1, 2015
• Last Updated: February 11, 2010

Record last verified: 2010-02

Locations

IT (1); BE (1)