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Procedure

TOGA for Obesity (TOGA® Trial)

Phase 3

Waitlist Available

Research Sponsored by Satiety, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of failure with non-surgical weight loss methods

Be between 18 and 65 years old

Must not have

Clinically severe cervical spinal disease, including cervical disc disease, vertebral osteophytes

History of cancer other than localized basal cell carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is designed to see if the TOGA System is a safe and effective treatment for morbid obesity and its associated health risks.

Who is the study for?

This trial is for adults aged 18-60 with a BMI of ≥40 and <55, or ≥35 with obesity-related health issues. Participants must have struggled with obesity for over 2.5 years, tried non-surgical weight loss without success, be willing to commit to lifestyle changes and dietary restrictions post-procedure, and live within 100 miles of the study center.

What is being tested?

The TOGA System's safety and effectiveness in treating morbid obesity are being tested against a sham (fake) procedure. Participants won't know which group they're in until after one year when those in the sham group can choose to receive the actual TOGA treatment.

What are the potential side effects?

While specific side effects aren't listed here, potential risks generally include those associated with bariatric surgery such as nausea, abdominal pain, nutritional deficiencies due to altered digestion, and possible need for reoperation if complications occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tried losing weight without surgery and it didn't work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe neck spine problems, like disc disease or bone spurs.

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I have had cancer before, but it was not just skin cancer.

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I have not had a heart attack or stroke in the last year.

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I have TMJ or am at risk for developing it.

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I have been diagnosed with gastroparesis.

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I have an autoimmune disease like lupus or scleroderma.

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I am currently taking prescription or over-the-counter diet drugs.

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I do not have serious esophagus problems like severe reflux or esophageal cancer.

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My obesity is due to hormonal or genetic reasons.

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I have a history of severe inflammatory bowel disease.

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I have an active stomach ulcer.

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I have chest pain due to heart problems.

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I have chronic pancreatitis.

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I have severe acid reflux.

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I have lesions that could bleed easily.

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I have a hiatal hernia that is at least 2cm large.

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I do not have severe liver disease like cirrhosis.

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I have structural issues in my digestive system, like diverticulum.

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I do not have severe heart/lung disease, HIV, or another serious illness.

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I am on long-term medication with aspirin, NSAIDs, or blood thinners.

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I do not have an infection affecting my whole body.

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My condition is advanced rheumatoid arthritis.

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I have had surgery on my stomach, esophagus, pancreas, or weight loss surgery.

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My thyroid condition is not controlled by medication.

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I cannot fully open my mouth or extend my neck.

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I have been diagnosed with congestive heart failure.

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I have a bleeding condition in my upper digestive tract.

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I have birth defects or blockages in my digestive system.

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I cannot walk by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TOGAExperimental Treatment1 Intervention

The TOGA procedure is an incision-free treatment using a set of flexible staplers introduced into the mouth and esophagus to create a sleeve in the stomach (transoral formation of a gastric sleeve). The TOGA sleeve limits the amount of food that can be eaten and gives the patient a feeling of fullness after a small meal.

Group II: ControlPlacebo Group1 Intervention

A gastric sleeve is not formed.

0 / 30Eligibility criteria met

Find a Location

Who is running the clinical trial?

Satiety, Inc.Lead Sponsor

1 Previous Clinical Trials

200 Total Patients Enrolled

1 Trials studying Obesity

200 Patients Enrolled for Obesity

Media Library

Transoral Gastroplasty (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT00661245 — Phase 3

Obesity Research Study Groups: TOGA, Control

Transoral Gastroplasty (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00661245 — Phase 3

Obesity Clinical Trial 2023: Transoral Gastroplasty Highlights & Side Effects. Trial Name: NCT00661245 — Phase 3

Obesity Patient Testimony for trial: Trial Name: NCT00661245 — Phase 3

~16 spots leftby Sep 2025

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