ObesityPhase 3TOGA®NCT00661245
Transoral Gastroplasty for the Treatment of Morbid Obesity
A Phase 3 study testing TOGA in people with Obesity, run by Satiety, Inc. at 11 sites in 2 countries.
Trial summary
The TOGA® trial is a prospective, multi-center, randomized sham-controlled trial designed to determine the safety and effectiveness of the TOGA System for the treatment of morbid obesity. The study will also determine the effect of the treatment on co-morbidities and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- TOGA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Jul 2008to Oct 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60
- BMI ≥ 40 kg/m2 and < 55 kg/m2, or BMI ≥ 35 kg/m2 with one or more significant co morbidities
- History of obesity for at least 2.5 years.
- History of stable weight (defined as a < 10% change in excess weight) for one year prior to the screening visit.
- History of failure with non-surgical weight loss methods.
- Suitable candidate for bariatric surgery based on the results of their psychological and physical evaluations.
- Understands risks of procedure, agrees to follow protocol requirements, including signing informed consent, returning for follow-up visits, completing all required testing, completing diet and behavior modification counseling, committing to prolonged lifestyle changes, and agrees to comply with the substantial dietary restrictions required by the procedure.
- Subject lives, and intends to remain, within a 100 mile radius of the study center for 5 years.
Who cannot join
- Hormonal or genetic cause for the obese state.
- History of cancer other than localized basal cell carcinoma.
- History of inflammatory disease of the gastrointestinal tract including Crohn's disease, ulcerative colitis, severe intractable esophagitis, gastric ulceration, or esophageal or duodenal ulceration.
- Active peptic ulcer disease.
- Significant known esophageal disease, including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, diffuse esophageal spasm, and symptoms of dysmotility.
- Myocardial infarction or cerebrovascular accident within past year.
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- Angina pectoris.
- Inability to extend neck or fully open mouth.
- Clinically severe cervical spinal disease, including cervical disc disease, vertebral osteophytes.
- Critically loose teeth.
- Temporomandibular joint syndrome (TMJ) or patients at risk for developing TMJ.
- Severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000)
- Gastroparesis
- Upper GI bleeding conditions such as esophageal or gastric varices, portal hypertensive gastropathy, congenital or acquired intestinal telangiectasis.
- Congenital or acquired anomalies of the GI tract such as atresias or stenoses.
- Structural abnormalities of the GI tract such as diverticulum.
- Lesions with increased risk of bleeding.
- Hiatal hernia ≥ 2cm.
- Severe cardiopulmonary disease or other serious organic disease, including HIV or cancer.
- Congestive heart failure.
- Uncontrolled hypertension (systolic >150 or diastolic > 100).
- Advanced rheumatoid arthritis.
- Severe or advanced liver disease (such as cirrhosis, chronic hepatitis, portal hypertension, etc.).
- Chronic pancreatitis.
- Any contraindication to endoscopy.
- Severe reflux disease.
- 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 24 months.
- Alcohol (> 80 gm/day of ethanol) or illicit drug use within the last 3 years.
- Prior gastric, esophageal, pancreatic or bariatric surgery.
- Currently on prescription or over the counter diet drugs.
- Chronic therapy with aspirin, NSAID or anticoagulants.
- Systemic infection at the time of the procedure.
- Patient with a known diagnosis or pre-existing symptoms of autoimmune connective tissue disease (i.e., systemic lupus erythematosus or scleroderma).
- Thyroid disease which is not controlled with medication
- Unacceptable medical risk (general health status would preclude surgery should a complication occur).
- Not ambulatory.
- Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
University Hospitals Geauga Medical Center
Chardon, Ohio, 44024
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
University of Missouri Health Care
Columbia, Missouri, 65212
University of Texas Medical School at Houston
Houston, Texas, 77056
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Columbia University Medical Center
New York, New York, 10032
University of California, San Francisco
San Francisco, California, 94110
Washington University in St. Louis - School of Medicine
St Louis, Missouri, 63110
UMass Memorial Medical Center (University of Massachusetts)
Worcester, Massachusetts, 01655
About this study
The TOGA® trial is a prospective, multi-center, randomized sham-controlled trial designed to determine the safety and effectiveness of the TOGA System for the treatment of morbid obesity. The study will also determine the effect of the treatment on co-morbidities and quality of life.
Subjects will be blinded to treatment or sham. Sham arm may crossover to TOGA treatment at 12 months.
- Conditions
- Obesity
- Being tested
- TOGA, Control
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOGADevice
Transoral Gastroplasty (TOGA®) System for gastric stapling.
ControlDevice
The control device (bougie dilator) is a FDA-cleared (Class II) device.
| Study group | Role | What they receive |
|---|---|---|
| TOGA | Experimental | 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. Receives: Device: TOGA |
| Control | Sham comparator | A gastric sleeve is not formed. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: The proportion of subjects with ≥ 25% EWL (excess weight loss); Safety: Pre-defined objective performance criteria (OPC)
Measured: 12 months
Secondary outcomes (1)
Improvement in Co-morbidities; Improvements in other Obesity Measures and in Quality of Life Measures
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Satiety, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661245
- Sponsor's protocol ID
- S107
- Acronym
- TOGA®
- Status last verified
- May 2009
- First submitted
- 15 Apr 2008
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoral Gastroplasty for the Treatment of Morbid Obesity
- ClinicalTrials.gov ID
- NCT00661245
- Acronym / sponsor ID
- TOGA® / S107
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Satiety, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2010 (estimated)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TOGA® trial is a prospective, multi-center, randomized sham-controlled trial designed to determine the safety and effectiveness of the TOGA System for the treatment of morbid obesity. The study will also determine the effect of the treatment on co-morbidities and quality of life.
Subjects will be blinded to treatment or sham. Sham arm may crossover to TOGA treatment at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOGA | Experimental | Device: TOGAThe 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. |
| Control | Sham comparator | Device: ControlA gastric sleeve is not formed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-60
- BMI ≥ 40 kg/m2 and < 55 kg/m2, or BMI ≥ 35 kg/m2 with one or more significant co morbidities
- History of obesity for at least 2.5 years.
- History of stable weight (defined as a < 10% change in excess weight) for one year prior to the screening visit.
- History of failure with non-surgical weight loss methods.
Key exclusion criteria (38 listed)
- Hormonal or genetic cause for the obese state.
- History of cancer other than localized basal cell carcinoma.
- History of inflammatory disease of the gastrointestinal tract including Crohn's disease, ulcerative colitis, severe intractable esophagitis, gastric ulceration, or esophageal or duodenal ulceration.
- Active peptic ulcer disease.
- Significant known esophageal disease, including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, diffuse esophageal spasm, and symptoms of dysmotility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOGATransoral Gastroplasty (TOGA®) System for gastric stapling. | Device | TOGA |
| ControlThe control device (bougie dilator) is a FDA-cleared (Class II) device. | Device | Control |
Primary outcome
Effectiveness: The proportion of subjects with ≥ 25% EWL (excess weight loss); Safety: Pre-defined objective performance criteria (OPC)
Time frame: 12 months
1 secondary outcome
Improvement in Co-morbidities; Improvements in other Obesity Measures and in Quality of Life Measures
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TOGA in people with Obesity, run by Satiety, Inc. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: The proportion of subjects with ≥ 25% EWL (excess weight loss); Safety: Pre-defined objective performance criteria (OPC) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2009.