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Obesity, PrimaryNCT05939973

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

A study testing g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors in people with Obesity, Primary, run by USGI Medical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Cross-over arm of the pilot study evaluating a treatment for obesity. Read more about this study

Who is it for?
Ages 22 to 60 years
Conditions the study is for
Obesity, Primary
What is being tested?
g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
19 Jan 2023to 14 Jun 2024
Phase
Interventional
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 22 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.
  • Dyslipidemia - Triglycerides > 250 mg/dl or cholesterol > 220 mg/dl or HDL < 35 mg/dl or LDL > 200 or use of lipid lowering medications.
  • Sleep Apnea - A formal sleep study test consistent with this diagnosis; Epworth sleepiness scale ≥ 6; Polysomnography with respiratory disturbance index ≥ 10 hyponeic and/or apneic episodes per hour of sleep.
  • Venous Stasis Disease - Presence or history of pretibial venous stasis ulcers.
  • Chronic Joint Disease - Deterioration of joint cartilage and the formation of new bone (bone spurs) at the margins of the joints.
  • Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease).
  • Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
  • Have not taken any prescription or over the counter weight loss medications OR those that can suppress appetite/induce weight loss for at least 6 months and agrees not to utilize for 12 months following study enrollment (including all stimulant medication).
  • Subjects must be willing to possibly forego any future weight loss procedures (i.e. Vertical Sleeve Gastrectomy) given the unknown long-term effects.
  • Residing within a reasonable distance from the Investigator's treating office (~50 miles) and willing and able to travel to the Investigator's office to complete all routine follow-up visits.

Who cannot join

  • History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
  • Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
  • Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
  • Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.
  • Pancreatic insufficiency/disease.
  • History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g. esophago-gastric motility issues and lower esophageal sphincter abnormalities).
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  • Pregnancy or plans of pregnancy in the next 12 months.
  • History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
  • Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1. Intranasal/inhaled steroids are acceptable.
  • Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.
  • History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.
  • Active gastric erosion, lesion, or gastric/duodenal ulcer.
  • History of or current platelet or coagulation dysfunction, such as hemophilia.
  • History or present use of insulin or insulin derivatives for treatment of diabetes.
  • Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 11 years at the time of enrollment.
  • If smoker, plans to quit smoking in the year after enrollment.
  • Portal hypertension and/or varices.
  • Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
  • Patient is currently using marijuana/cannabis for either medicinal or recreational use, or has plans to start using over the next 12 months.
  • Present or history of psychosis, bipolar disease, or obsessive-compulsive disorder after pre-enrollment history and medical /psychological assessment.
  • Beck Depression Inventory (Short) Score ≥ 12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment. 1
  • Patient score >2 in any of the 9 identified symptoms on the Gastroparesis Cardinal Symptom Index (GCSI)
  • Patient with a 13C-Spirulina Gastric Emptying Breath Test (GEBT) result that is less than a kPCD/min of 34.4 at 120 minutes or 43 at 180 minutes
  • Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30 minutes).
  • Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
  • Participating in another clinical study that would conflict with the requirements of the study protocol as described.
  • Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
  • Physician's assessment that the subject is not an appropriate candidate.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Feasibility Study Examining Safety and Preliminary Effectiveness of a Procedural Technique Using an Endoscopic Suturing Device (g-Cath EZ Delivery Catheter With Snowshoe Suture Anchors) and Associated Devices for the Treatment of Primary Obesity

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

Read the detailed description

This is a multi-center, open-label, cross-over arm from the 2-group randomized pilot study evaluating a treatment for obesity. The intent is to evaluate the safety and preliminary efficacy of a new Snowshoe suture placement pattern, POSE2.0 (sutures placed in the mid + distal body without fundus), with a moderate intensity diet and exercise program. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP). Efficacy will be evaluated based on changes in weight loss through 12 months. Adverse events will be recorded throughout the duration of the study.

Being tested
g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • g-Cath EZ Delivery Catheter with Snowshoe Suture AnchorsDevice

    The intent is to evaluate the safety and preliminary efficacy of a new Snowshoe suture placement pattern, POSE2.0 (sutures placed in the mid + distal body without fundus), with a moderate intensity diet and exercise program.

Study groups in NCT05939973
Study groupRoleWhat they receive
CrossoverOtherContinuation of POSE2.0 expansion study evaluating the safety and preliminary effectiveness of the Pose 2 procedure using the g-Cath EZ Suture Anchor Delivery Catheter as a primary weight loss intervention in the control arm, defined as crossover subjects from POSE2.0 Expansion Study.
Receives: Device: g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Percent TBWL at 3 months

    Mean Percent TBWL at 3 months.

    Measured: 3 months.

  2. Mean Percent TBWL at 12 months

    Mean Percent TBWL at 12 months.

    Measured: 12 months.

  3. Percentage of subjects with ≥5% TBWL at 3 months

    Percentage of subjects with ≥5% TBWL at 3 months.

    Measured: 3 months.

  4. Percentage of subjects with ≥5% TBWL at 12 months

    Percentage of subjects with ≥5% TBWL at 12 months.

    Measured: 12 months.

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

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

    Measured: 12 months

Secondary outcomes (11)

  1. To investigate observational efficacy objectives of the POSE2.0 procedure

    Change from baseline at 3 months in Percent EWL

    Measured: Change from baseline at 3 months

  2. To investigate observational efficacy objectives of the POSE2.0 procedure

    Change from baseline at 12 months in Percent EWL

    Measured: Change from baseline at 12 months

  3. To investigate observational efficacy objectives of the POSE2.0 procedure

    Change from baseline at 3 months in BMI reduction

    Measured: Change from baseline at 3 months

  4. To investigate observational efficacy objectives of the POSE2.0 procedure

    Change from baseline at 12 months in BMI reduction

    Measured: Change from baseline at 12 months

  5. To investigate observational efficacy objectives of the POSE2.0 procedure

    Change from baseline at 3 months in weight loss (lb/kg)

    Measured: Change from baseline at 3 months

  6. To investigate observational efficacy objectives of the POSE2.0 procedure

    Change from baseline at 12 months in weight loss (lb/kg)

    Measured: Change from baseline at 12 months

  7. To investigate observational efficacy objectives of the POSE2.0 procedure

    Change from baseline at 3 months in waist circumference

    Measured: Change from baseline at 3 months

  8. To investigate observational efficacy objectives of the POSE2.0 procedure

    Change from baseline at 12 months in waist circumference

    Measured: Change from baseline at 12 months

  9. Change from baseline at 12 months in Quality of Life Scores

    The IWQOL-Lite questionnaire is a validated, 31-item, self-report measure of obesity-specific quality of life. In addition to a total score, there are scores on five domains: Physical function; Self-esteem; Sexual life; Public distress; Work.

    Measured: Change from baseline at 12 months

  10. Change from baseline at 12 months in Co-morbidities

    Change from baseline at 12 months in Co-morbidities.

    Measured: Change from baseline at 12 months

  11. Change from baseline at 12 months in liver function

    Liver function panel will be administered at baseline and at 12 months to assess change in liver function.

    Measured: Change from baseline at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2023
  2. Study start19 Jan 2023
  3. Primary completion14 Jun 2024
  4. Study completion14 Jun 2024

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a multi-center, open-label, cross-over arm from the 2-group randomized pilot study evaluating a treatment for obesity.
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05939973
Sponsor's protocol ID
50598 TPR
Status last verified
May 2026
First submitted
23 Jun 2023
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors in people with Obesity, Primary, run by USGI Medical at 1 site in United States.

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 17 inclusion and 28 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: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean Percent TBWL at 3 months (time frame: 3 months.). The study lists 5 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 NCT05939973.

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 15 May 2026.

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