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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 12 months
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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness: The proportion of subjects with ≥ 25% EWL (excess weight loss); Safety: Pre-defined objective performance criteria (OPC)
Secondary outcome measures
Improvement in Co-morbidities; Improvements in other Obesity Measures and in Quality of Life Measures

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.

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 Jul 2025