CompletedNot Applicable

A Feasibility Study for the Treatment of Primary Obesity Cross-over Arm

United States3 participantsStarted 2023-01-19

Plain-language summary

Cross-over arm of the pilot study evaluating a treatment for obesity.

Who can participate

Age range

22 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of signed and dated informed consent form.
. Subject agrees to be compliant with study requirements and adhere to post-operative dietary \& exercise recommendations for the duration of the study.
. Subjects between the ages of 22-60 years.
. If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
. Met BMI inclusion criteria when enrolled in the study as defined by a Body Mass Index (BMI) of ≥ 35 and \< 40 with one or more obesity related co-morbid conditions (defined by 1991 NIH Guidelines (Appropriateness Criteria for Bariatric Surgery: Beyond the NIH Guidelines).
. Pre-diabetes - Fasting plasma glucose test \>100 mg/dl but ≤125 or oral glucose tolerance test ≥140 mg/dl but \<200.
. Diabetes - Individuals taking insulin and/or oral hypoglycemic medications or have a fasting glucose \>126 mg/dl.
. Hypertension - SBP\>140 or DBP\>90 or the use of an antihypertensive medication.

Exclusion criteria

. History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Percent TBWL at 3 months

Timeframe: 3 months.

Mean Percent TBWL at 12 months

Timeframe: 12 months.

Percentage of subjects with ≥5% TBWL at 3 months

Timeframe: 3 months.

Percentage of subjects with ≥5% TBWL at 12 months

Timeframe: 12 months.

Overall incidence of device and procedure related adverse events through 12 months

Timeframe: 12 months

Trial details

NCT IDNCT05939973

SponsorUSGI Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-14

View on ClinicalTrials.gov More Obesity, Primary trials

Who can participate

Age range

22 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of signed and dated informed consent form.
. Subject agrees to be compliant with study requirements and adhere to post-operative dietary \& exercise recommendations for the duration of the study.
. Subjects between the ages of 22-60 years.
. If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
. Met BMI inclusion criteria when enrolled in the study as defined by a Body Mass Index (BMI) of ≥ 35 and \< 40 with one or more obesity related co-morbid conditions (defined by 1991 NIH Guidelines (Appropriateness Criteria for Bariatric Surgery: Beyond the NIH Guidelines).
. Pre-diabetes - Fasting plasma glucose test \>100 mg/dl but ≤125 or oral glucose tolerance test ≥140 mg/dl but \<200.
. Diabetes - Individuals taking insulin and/or oral hypoglycemic medications or have a fasting glucose \>126 mg/dl.
. Hypertension - SBP\>140 or DBP\>90 or the use of an antihypertensive medication.

Exclusion criteria

. History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.

What they're measuring

Mean Percent TBWL at 3 months

Timeframe: 3 months.

Mean Percent TBWL at 12 months

Timeframe: 12 months.

Percentage of subjects with ≥5% TBWL at 3 months

Timeframe: 3 months.

Percentage of subjects with ≥5% TBWL at 12 months

Timeframe: 12 months.

Overall incidence of device and procedure related adverse events through 12 months

Timeframe: 12 months