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

NCT05939973 | Unknown DMC FDA Device

• 1 other identifier: 50598 TPR
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity, Primary

Outcome Measures

Primary Outcomes (5)

• Mean Percent TBWL at 3 months

  Mean Percent TBWL at 3 months.

  3 months.

• Mean Percent TBWL at 12 months

  Mean Percent TBWL at 12 months.

  12 months.

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

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

  3 months.

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

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

  12 months.

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

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

  12 months

Secondary Outcomes (11)

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

  Change from baseline at 3 months

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

  Change from baseline at 12 months

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

  Change from baseline at 3 months

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

  Change from baseline at 12 months

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

  Change from baseline at 3 months

Study Arms (1)

Crossover

OTHER

Continuation 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.

Device: g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors

Interventions

g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors DEVICE

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.

Crossover

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• USGI Medical: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barham Abu Dayyeh, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multi-center, open-label, cross-over arm from the 2-group randomized pilot study evaluating a treatment for obesity.

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 11, 2023
• Study Start: January 19, 2023
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 11, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)