The USGI Medical ESSENTIAL Study for Weight Loss

NCT01958385 | Completed FDA Device

• 1 other identifier: G130163
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Obesity

Keywords

Total Body Weight Loss

Outcome Measures

Primary Outcomes (1)

• Total Body Weight Loss

  Evaluate the effectiveness of the g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical, San Clemente, CA, USA) with diet and exercise as an early weight loss intervention for Class I obesity subjects with at least one non-severe obesity related co-morbid condition or Class II obesity subjects with or without a non-severe obesity related co-morbid condition compared to a sham procedure, diet and exercise group.

  Enrollment to 12 months

Secondary Outcomes (3)

• Quality of Life scores (IWQOL)

  enrollment to 12 months

• Comorbid status

  Enrollment to 12 months

• Eating Behavior changes

  Enrollment to 12 months

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

The treatment of obese patients with the placement of g-Cath EZ suture anchors along with Diet and Exercise

Device: placement of g-Cath EZ suture anchors; Behavioral: Diet and Exercise

Sham Group

SHAM COMPARATOR

The treatment of obese patients with the sham procedure along with Diet and Exercise

Procedure: Sham procedure; Behavioral: Diet and Exercise

Interventions

placement of g-Cath EZ suture anchors DEVICE

Also known as: g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical)

Treatment group

Sham procedure PROCEDURE

Sham Group

Diet and Exercise BEHAVIORAL

A structured diet and exercise plan

Sham Group; Treatment group

Eligibility Criteria

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

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.

Sponsors & Collaborators

• USGI Medical: lead

Study Sites (11)

Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

DeWitt Daughtry Family Department of Surgery University of Miami Miller School of Medicine

Miami, Florida, 33166, United States

Location

Hamilton Medical Center

Dalton, Georgia, 30722, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Crescent City Surgical Centre

Covington, Louisiana, 70433, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02120, United States

Location

University of MN, Fairview Health Services

Minneapolis, Minnesota, 55455, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Lexington Medical Center

West Columbia, South Carolina, 29169, United States

Location

Baptist Memorial

Memphis, Tennessee, 38120, United States

Location

Related Publications (1)

• Sullivan S, Swain JM, Woodman G, Antonetti M, De La Cruz-Munoz N, Jonnalagadda SS, Ujiki M, Ikramuddin S, Ponce J, Ryou M, Reynoso J, Chhabra R, Sorenson GB, Clarkston WK, Edmundowicz SA, Eagon JC, Mullady DK, Leslie D, Lavin TE, Thompson CC. Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial. Obesity (Silver Spring). 2017 Feb;25(2):294-301. doi: 10.1002/oby.21702. Epub 2016 Dec 21.

  PMID: 28000425 RESULT

MeSH Terms

Conditions

Obesity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tom Lavin, MD

  Crescent City Surgical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 9, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)