Endoscopic Bariatric Stapling Pilot Study (TOGA®)

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Device: TOGA® System

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • ULB (Universite Libre de Bruxelles) - Erasme Hospital
• Italy
  • Rome, Italy
    • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TOGA subjects	Device: TOGA® System; Formation of restrictive sleeve via transoral gastric stapling for treatment of obesity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Improvement in Co-morbidities	up to 60 months
Improvements in other Obesity Measures and Change in Quality Of Life Measures	up to 60 months

Collaborators and Investigators

• Sponsor: Satiety, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: February 10, 2010
• First Submitted That Met QC Criteria: February 10, 2010
• First Posted (ESTIMATE): February 11, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 11, 2010
• Last Update Submitted That Met QC Criteria: February 10, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: TR-0009 Rev F