Endoscopic Bariatric Stapling Pilot Study

NCT ID: NCT01067625

Last Updated: 2010-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TOGA subjects

Group Type: EXPERIMENTAL

TOGA® System

Intervention Type: DEVICE

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

Interventions

TOGA® System

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 18 years - 60 years

2. 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]

3. History of obesity for at least 2.5 years

4. History of failure with non-surgical weight loss methods.

5. Agree to comply with the substantial dietary restrictions required by the procedure.

6. 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.

Exclusion Criteria

1. Patient history of inflammatory disease of the gastrointestinal tract including Crohn's disease or ulcerative colitis.

2. Significant known esophageal disease including grade 3-4 esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, nutcracker esophagus, achalasia, esophageal dysmotility.

3. Severe coagulopathy, upper GI bleeding conditions such as esophageal or gastric varices, congenital or acquired telangiectasia.

4. Congenital or acquired anomalies of the GI tract such as atresias or stenoses.

5. Hiatal hernia ≥2cm

6. Severe cardiopulmonary disease or other serious organic disease including HIV or cancer.

7. 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.

8. Current alcohol or drug addiction.

9. 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.

10. Previous gastric, esophageal, pancreatic, or bariatric surgery.

11. Infection anywhere in the body at the time of the procedure.

12. Patient history of scleroderma.

13. Thyroid disease which is not controlled with medication.

14. Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.

15. Known active H-pylori infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satiety, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Satiety, Inc.

Locations

ULB (Universite Libre de Bruxelles) - Erasme Hospital

Brussels, , Belgium

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Rome, , Italy

Countries

Belgium; Italy

References

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.

Reference Type: DERIVED

PMID: 22136774 (View on PubMed)

Other Identifiers

TR-0009 Rev F

Identifier Type: -

Identifier Source: org_study_id