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Endoscopic Bariatric Stapling Pilot Study (TOGA®)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067625
Recruitment Status : Unknown
Verified February 2010 by Satiety, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : February 11, 2010
Last Update Posted : February 11, 2010
Information provided by:
Satiety, Inc.

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.

Condition or disease Intervention/treatment Phase
Obesity Device: TOGA® System Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2006
Estimated Primary Completion Date : December 2015

Arm Intervention/treatment
Experimental: TOGA subjects Device: TOGA® System
Formation of restrictive sleeve via transoral gastric stapling for treatment of obesity

Primary Outcome Measures :
  1. Percent excess weight loss (%EWL) [ Time Frame: up to 60 months ]
  2. Adverse events, including serious adverse events, will be recorded to determine safety [ Time Frame: up to 60 months ]

Secondary Outcome Measures :
  1. Improvement in Co-morbidities [ Time Frame: up to 60 months ]
  2. Improvements in other Obesity Measures and Change in Quality Of Life Measures [ Time Frame: up to 60 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01067625

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ULB (Universite Libre de Bruxelles) - Erasme Hospital
Bruxelles, Belgium, 1070
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Rome, Italy
Sponsors and Collaborators
Satiety, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Allan L. Abati, Ph.D., VP, RA/QA and Clinical Programs, Satiety, Inc. Identifier: NCT01067625    
Other Study ID Numbers: TR-0009 Rev F
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: February 11, 2010
Last Verified: February 2010