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ObesityNCT03837691

A Feasibility Study for the Treatment of Primary Obesity

A study testing Placement of Snowshoe Suture Anchors and Moderate Intensity Diet & Exercise Program in people with Obesity, run by USGI Medical at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study has been expanded to a four center, open-label, 2-group randomized 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
What is being tested?
Placement of Snowshoe Suture Anchors and Moderate Intensity Diet & Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesUnited States
Study dates
10 Oct 2019to 15 Oct 2023
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.
  • Have 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 hypopneic 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.
  • 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.
  • 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.
  • 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. If significant findings for depression and/or suicidal ideation are identified, the psychologist(s) assigned to the study will be contacted and arrangement will be made for immediate intervention according to the Institution's standard procedure.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Memorial Hermann-Texas Medical Center

    Houston, Texas, 77030

  • University of Miami, Miller School of Medicine

    Miami, Florida, 33166

  • 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 and Associated Devices for the Treatment of Primary Obesity

This study has been expanded to a four center, open-label, 2-group randomized pilot study evaluating a treatment for obesity.

Read the detailed description

This study has been expanded to a four center, open-label, 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, Pose 2 (sutures placed in the mid + distal body without fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. 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 for all subjects through 12 months. Adverse events will be recorded throughout the duration of the study.

Conditions
Obesity
Being tested
Placement of Snowshoe Suture Anchors, Moderate Intensity Diet & Exercise Program
Medical subject headings
Obesity

What participants receive

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

  • Placement of Snowshoe Suture AnchorsDevice

    Snowshoe suture anchors from g-Cath EZ Delivery Catheters are placed in the stomach with the aid of a Transport, g-Lix and g-Prox device

  • Moderate Intensity Diet & Exercise ProgramBehavioural

    After placement of the snowshoe suture anchors in the stomach, subjects are asked to follow a moderate intensity diet and exercise program

Study groups in NCT03837691
Study groupRoleWhat they receive
g-Cath EZExperimentalPlacement of Snowshoe suture anchors from g-Cath EZ Delivery Catheters, in a defined pattern in the mid and distal portions of the stomach, along with a moderate intensity diet \& exercise program, to treat primary obesity.
Receives: Device: Placement of Snowshoe Suture Anchors; Behavioral: Moderate Intensity Diet & Exercise Program
Diet and ExerciseNo interventionA moderate intensity diet \& exercise program to treat primary obesity

What is being measured

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

  1. Primary weight loss intervention

    To evaluate 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.

    Measured: 12 months

Secondary outcomes (1)

  1. Changes in gastric emptying

    To gather information on changes in gastric emptying breath test findings in order to correlate changes with weight loss outcomes.

    Measured: 2 & 6 months

Timeline

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

  1. First posted12 Feb 2019
  2. Study start10 Oct 2019
  3. Primary completion15 Jun 2023 (estimated)
  4. Study completion15 Oct 2023 (estimated)

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
Randomised
Intervention model
Single group
Model description
Forty Patient Study
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03837691
Sponsor's protocol ID
50527 TPR
Status last verified
May 2023
First submitted
8 Feb 2019
Last updated
19 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Placement of Snowshoe Suture Anchors and Moderate Intensity Diet & Exercise Program in people with Obesity, run by USGI Medical at 4 sites 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 27 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 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

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?

Primary weight loss intervention (time frame: 12 months). 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 NCT03837691.

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 19 May 2023.

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