The USGI Medical ESSENTIAL Study for Weight Loss

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity

In brief

This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.

Key facts

Study ID

NCT01958385

Run by

USGI Medical

People needed

377

Starts

2013-12-01

Expected to finish

2016-08-01

Last updated by the study team

2017-04-04

Who can join

Age: 22 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent.
• Be male or female 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 and baseline.
• Have a Body Mass Index (BMI) of ≥30 and <35 with at least one non-severe co-morbid obesity related condition or a BMI ≥ 35 and < 40 with or without a non-severe obesity related co-morbid condition, where a severe co-morbid condition is defined as severe if symptoms cause severe discomfort, performance of daily activities is compromised, and/or condition is not entirely controlled with prescription drug therapy.
• Have had no significant weight change (+/- 5% of total body weight) in last 6 months.
• Have an American Society Anesthesiologists-PS score ≤ 2 (Appendix III).
• Agrees not to have any additional weight loss interventional procedures, liposuction, or take any over the counter or prescription weight loss medication for 24 months following study enrollment.
• Have not taken any prescription or over the counter weight loss medications for at least 6 months and agrees not to utilize for 12 months following study enrollment.
• Be willing to cooperate with post-operative dietary recommendations and assessment tests.
• Reside within a reasonable distance from the Investigator's treating office (\~50 miles) and able and willing to travel to the Investigator's office to complete all routine follow-up visits.

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 endolumenal instruments.
• Severe 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 prescription drug therapy.
• Large hiatal hernia (>3 cm) by history or as determined by pre-randomization endoscopy.
• Pancreatic insufficiency/disease.
• Active gastric erosions or gastric/duodenal ulcer.
• History of gastroparesis or symptoms that would be suggestive of gastroparesis.
• Pregnancy or plans of pregnancy in the next 12 months.
• Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
• History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
• 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 10 years at the time of enrollment
• Quit smoking within the last 6 months at time of enrollment or plans to quit smoking in the year after enrollment
• Portal hypertension and/or varices.
• Gastric outlet obstruction or stenosis.
• Significant abnormality identified during Visit 2 (randomization visit) with endoscopy revealing large hiatal hernia, gastric ulcer, gastric erosions, etc.
• Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
• Beck Depression Inventory (Short) Score ≥12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment.
• Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment.
• Non-ambulatory or has significant impairment of mobility.
• Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.
• Participating in another clinical study.
• Is a relative of investigator or his/her staff, or is employed by investigator or institution involved in the 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.

Where it is running

• Scottsdale Healthcare — Scottsdale, Arizona, United States
• DeWitt Daughtry Family Department of Surgery University of Miami Miller School of Medicine — Miami, Florida, United States
• Hamilton Medical Center — Dalton, Georgia, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Crescent City Surgical Centre — Covington, Louisiana, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• University of MN, Fairview Health Services — Minneapolis, Minnesota, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Lexington Medical Center — West Columbia, South Carolina, United States
• Baptist Memorial — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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