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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
TOGA® Trial 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.
TOGA® Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried losing weight without surgery and it didn't work.
TOGA® Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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
TOGA® 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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your weight has not changed by more than 10% in the past year.I have severe neck spine problems, like disc disease or bone spurs.I have been obese for over 2.5 years.I have had cancer before, but it was not just skin cancer.I have not had a heart attack or stroke in the last year.I have TMJ or am at risk for developing it.I have been diagnosed with gastroparesis.I have an autoimmune disease like lupus or scleroderma.I have been obese for over 2.5 years.I am currently taking prescription or over-the-counter diet drugs.I do not have serious esophagus problems like severe reflux or esophageal cancer.I am between 18 and 60 years old.I have tried losing weight without surgery but it didn't work.My obesity is due to hormonal or genetic reasons.I have a history of severe inflammatory bowel disease.I have an active stomach ulcer.I have chest pain due to heart problems.I have chronic pancreatitis.I have severe acid reflux.I have lesions that could bleed easily.I have a hiatal hernia that is at least 2cm large.I do not have severe liver disease like cirrhosis.I have structural issues in my digestive system, like diverticulum.I do not have severe heart/lung disease, HIV, or another serious illness.I am on long-term medication with aspirin, NSAIDs, or blood thinners.I do not have an infection affecting my whole body.My health is too poor to safely undergo surgery if needed.I have tried losing weight without surgery and it didn't work.I am considered fit for weight loss surgery by my doctors.My condition is advanced rheumatoid arthritis.I have had surgery on my stomach, esophagus, pancreas, or weight loss surgery.My thyroid condition is not controlled by medication.My BMI is between 35 and 55, and I may have significant health issues if it's below 40.I am considered fit for weight loss surgery by my doctors.I cannot fully open my mouth or extend my neck.I have been diagnosed with congestive heart failure.I have a bleeding condition in my upper digestive tract.I have birth defects or blockages in my digestive system.I cannot walk by myself.
Research Study Groups:
This trial has the following groups:- Group 1: TOGA
- Group 2: Control
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Obesity Patient Testimony for trial: Trial Name: NCT00661245 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I participate in this research project?
"The ideal participants for this study are obese individuals aged 18 to 60. Currently, the trial is looking to recruit 275 people in total."
Answered by AI
What are some known risks associated with TOGA?
"On a scale from 1 to 3, our team at Power estimates the safety of TOGA to be a 3 because this is a Phase 3 trial. This means that there is some data supporting efficacy and multiple rounds of data supporting safety."
Answered by AI
Are elderly patients welcome in this clinical trial?
"The ideal candidate for this study is someone who is over 18 but less than 60 years old."
Answered by AI
Is this particular clinical trial being conducted in several hospitals around the city?
"There are 10 total sites for this trial, which include locations in Columbia, New york and Cleveland. There may be a location near you to reduce travel if enrolling."
Answered by AI
Are we still able to enroll subjects for this research?
"According to the most recent update on clinicaltrials.gov, this study is not looking for participants at this time. This particular trial was first posted on July 1st, 2008 but hasn't been updated since May 4th, 2009. There are other opportunities available though; 998 other studies are currently recruiting patients."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Other
California
Texas
How old are they?
65+
18 - 65
What site did they apply to?
University of California, San Francisco
Columbia University Medical Center
Other
University of Texas Medical School at Houston
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
0
3+
What questions have other patients asked about this trial?
If I am picked how soon can I start ? How long does screening take? What's the process?
PatientReceived 1 prior treatment
How long does it last and will there be any monetary compensation?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I’ve been obese for 13 years. I have tried few times to loose weight. I have tried 3 other times loose weight.
PatientReceived no prior treatments
I have tried several drugs that do not work. I have tried all kinds of methods for weight loss and failed.
PatientReceived 2+ prior treatments
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