Endoscopic Bariatric Stapling Pilot Study (TOGA®)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Satiety, Inc.
ClinicalTrials.gov Identifier:
NCT01067625
First received: February 10, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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 Intervention Phase
Obesity
Device: TOGA® System
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Satiety, Inc.:

Primary Outcome Measures:
  • Percent excess weight loss (%EWL) [ Time Frame: up to 60 months ] [ Designated as safety issue: Yes ]
  • Adverse events, including serious adverse events, will be recorded to determine safety [ Time Frame: up to 60 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in Co-morbidities [ Time Frame: up to 60 months ] [ Designated as safety issue: Yes ]
  • Improvements in other Obesity Measures and Change in Quality Of Life Measures [ Time Frame: up to 60 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: February 2006
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOGA subjects Device: TOGA® System
Formation of restrictive sleeve via transoral gastric stapling for treatment of obesity

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067625

Locations
Belgium
ULB (Universite Libre de Bruxelles) - Erasme Hospital
Bruxelles, Belgium, 1070
Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Rome, Italy
Sponsors and Collaborators
Satiety, Inc.
  More Information

No publications provided by Satiety, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allan L. Abati, Ph.D., VP, RA/QA and Clinical Programs, Satiety, Inc.
ClinicalTrials.gov Identifier: NCT01067625     History of Changes
Other Study ID Numbers: TR-0009 Rev F
Study First Received: February 10, 2010
Last Updated: February 10, 2010
Health Authority: Belgium: Institutional Review Board
Italy: Ethics Committee

ClinicalTrials.gov processed this record on October 22, 2014