Endoscopic Bariatric Stapling Pilot Study

Obesity Clinical Trial

— TOGA®  

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01067625
• Other study ID #: TR-0009 Rev F
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: February 10, 2010
• Last updated: February 10, 2010
• Start date: February 2006

Study information

• Verified date: February 2010
• Source: Satiety, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• TOGA® System
Formation of restrictive sleeve via transoral gastric stapling for treatment of obesity

Locations

Country	Name	City	State
Belgium	ULB (Universite Libre de Bruxelles) - Erasme Hospital	Bruxelles
Italy	Università Cattolica del Sacro Cuore - Policlinico A. Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Satiety, Inc.

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent excess weight loss (%EWL)		up to 60 months	Yes
Primary	Adverse events, including serious adverse events, will be recorded to determine safety		up to 60 months	Yes
Secondary	Improvement in Co-morbidities		up to 60 months	Yes
Secondary	Improvements in other Obesity Measures and Change in Quality Of Life Measures		up to 60 months	Yes