Clinical trial NCT01067625: Endoscopic Bariatric Stapling Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Satiety, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percent excess weight loss (%EWL)
timeFrame: up to 60 months
measure: Adverse events, including serious adverse events, will be recorded to determine safety
timeFrame: up to 60 months
Secondary outcomes:
measure: Improvement in Co-morbidities
timeFrame: up to 60 months
measure: Improvements in other Obesity Measures and Change in Quality Of Life Measures
timeFrame: up to 60 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: ULB (Universite Libre de Bruxelles) - Erasme Hospital
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Study officials:
References:
citation: 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.