ObesityPhase 1TOGA®NCT01067625
Endoscopic Bariatric Stapling Pilot Study
A Phase 1 study testing TOGA® System in people with Obesity, run by Satiety, Inc. at 2 sites in 2 countries.
Trial summary
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. 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® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2006to Dec 2015
- Phase
- Phase 1
- 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 years - 60 years
- 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]
- History of obesity for at least 2.5 years
- History of failure with non-surgical weight loss methods.
- Agree to comply with the substantial dietary restrictions required by the procedure.
- 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.
Who cannot join
- Patient history of inflammatory disease of the gastrointestinal tract including Crohn's disease or ulcerative colitis.
- Significant known esophageal disease including grade 3-4 esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, nutcracker esophagus, achalasia, esophageal dysmotility.
- Severe coagulopathy, upper GI bleeding conditions such as esophageal or gastric varices, congenital or acquired telangiectasia.
- Congenital or acquired anomalies of the GI tract such as atresias or stenoses.
- Hiatal hernia ≥2cm
- Severe cardiopulmonary disease or other serious organic disease including HIV or cancer.
Show all 15Show fewer
- 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.
- Current alcohol or drug addiction.
- 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.
- Previous gastric, esophageal, pancreatic, or bariatric surgery.
- Infection anywhere in the body at the time of the procedure.
- Patient history of scleroderma.
- Thyroid disease which is not controlled with medication.
- Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
- Known active H-pylori infection.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site
ULB (Universite Libre de Bruxelles) - Erasme Hospital
Brussels, 1070
About this study
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.
- Conditions
- Obesity
- Being tested
- TOGA® System
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOGA® SystemDevice
Formation of restrictive sleeve via transoral gastric stapling for treatment of obesity
| Study group | Role | What they receive |
|---|---|---|
| TOGA subjects | Experimental | Not described Receives: Device: TOGA® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent excess weight loss (%EWL)
Measured: up to 60 months
Adverse events, including serious adverse events, will be recorded to determine safety
Measured: up to 60 months
Secondary outcomes (2)
Improvement in Co-morbidities
Measured: up to 60 months
Improvements in other Obesity Measures and Change in Quality Of Life Measures
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startFeb 2006
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Satiety, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067625
- Sponsor's protocol ID
- TR-0009 Rev F
- Acronym
- TOGA®
- Status last verified
- Feb 2010
- First submitted
- 10 Feb 2010
- Last updated
- 11 Feb 2010
- Results posted
- No
Publications
Familiari P, Costamagna G, Blero D, Le Moine O, Perri V, Boskoski I, Coppens E, Barea M, Iaconelli A, Mingrone G, Moreno C, Deviere J. Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome. Gastrointest Endosc. 2011 Dec;74(6):1248-58. doi: 10.1016/j.gie.2011.08.046.
PubMed 22136774
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Bariatric Stapling Pilot Study
- ClinicalTrials.gov ID
- NCT01067625
- Acronym / sponsor ID
- TOGA® / TR-0009 Rev F
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Satiety, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Dec 2015 (estimated)
- First posted
- 11 Feb 2010 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOGA subjects | Experimental | Device: TOGA® System |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 years - 60 years
- 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]
- History of obesity for at least 2.5 years
- History of failure with non-surgical weight loss methods.
- Agree to comply with the substantial dietary restrictions required by the procedure.
Key exclusion criteria (15 listed)
- Patient history of inflammatory disease of the gastrointestinal tract including Crohn's disease or ulcerative colitis.
- Significant known esophageal disease including grade 3-4 esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, nutcracker esophagus, achalasia, esophageal dysmotility.
- Severe coagulopathy, upper GI bleeding conditions such as esophageal or gastric varices, congenital or acquired telangiectasia.
- Congenital or acquired anomalies of the GI tract such as atresias or stenoses.
- Hiatal hernia ≥2cm
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 |
|---|---|---|
| TOGA® SystemFormation of restrictive sleeve via transoral gastric stapling for treatment of obesity | Device | TOGA subjects |
Primary outcome
Percent excess weight loss (%EWL)
Time frame: up to 60 months
Adverse events, including serious adverse events, will be recorded to determine safety
Time frame: up to 60 months
2 secondary outcomes
Improvement in Co-morbidities
Time frame: up to 60 months
Improvements in other Obesity Measures and Change in Quality Of Life Measures
Time frame: up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2010.
- Derived from this study: PubMed 22136774Familiari P, Costamagna G, Blero D, Le Moine O, Perri V, Boskoski I, Coppens E, Barea M, Iaconelli A, Mingrone G, Moreno C, Deviere J. Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome. Gastrointest Endosc. 2011 Dec;74(6):1248-58. doi: 10.1016/j.gie.2011.08.046.
Related trials for Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Recruiting
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
RecruitingPhase 1
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Valid MeSH Conditiongs
Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Skin Laxity, Localized Adiposity
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TOGA® System in people with Obesity, run by Satiety, Inc. at 2 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 6 inclusion and 15 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 11 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Italy. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percent excess weight loss (%EWL) (time frame: up to 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01067625, which also lists 1 linked publication.
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 11 Feb 2010.