ClinicalTrials.Veeva

Menu

Endoscopic Bariatric Stapling Pilot Study (TOGA®)

S

Satiety, Inc.

Status and phase

Unknown
Phase 1

Conditions

Obesity

Treatments

Device: TOGA® System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01067625
TR-0009 Rev F

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

TOGA subjects
Experimental group
Treatment:
Device: TOGA® System

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems