A Feasibility Study for the Treatment of Primary Obesity

NCT03837691 | Unknown DMC FDA Device

• 1 other identifier: 50527 TPR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (1)

• Changes in gastric emptying

  2 & 6 months

Study Arms (2)

g-Cath EZ

EXPERIMENTAL

Placement 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.

Device: Placement of Snowshoe Suture Anchors; Behavioral: Moderate Intensity Diet & Exercise Program

Diet and Exercise

NO INTERVENTION

A moderate intensity diet \& exercise program to treat primary obesity

Interventions

Placement of Snowshoe Suture Anchors DEVICE

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

g-Cath EZ

Moderate Intensity Diet & Exercise Program BEHAVIORAL

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

g-Cath EZ

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.
• 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.
• 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).

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 (4)

University of Miami, Miller School of Medicine

Miami, Florida, 33166, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Hermann-Texas Medical Center

Houston, Texas, 77030, 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

  Mayo

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Forty Patient Study

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: October 10, 2019
• Primary Completion: June 15, 2023
• Study Completion: October 15, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

US (4)