Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
377 participants
INTERVENTIONAL
2013-12-01
2016-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment group
The treatment of obese patients with the placement of g-Cath EZ suture anchors along with Diet and Exercise
placement of g-Cath EZ suture anchors
Diet and Exercise
A structured diet and exercise plan
Sham Group
The treatment of obese patients with the sham procedure along with Diet and Exercise
Sham procedure
Diet and Exercise
A structured diet and exercise plan
Interventions
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placement of g-Cath EZ suture anchors
Sham procedure
Diet and Exercise
A structured diet and exercise plan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Be male or female subjects between the ages of 22-60 years.
3. 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.
4. 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.
5. Have had no significant weight change (+/- 5% of total body weight) in last 6 months.
6. Have an American Society Anesthesiologists-PS score ≤ 2 (Appendix III).
7. 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.
8. 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.
9. Be willing to cooperate with post-operative dietary recommendations and assessment tests.
10. 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.
Exclusion Criteria
2. Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments.
3. 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.
4. Large hiatal hernia (\>3 cm) by history or as determined by pre-randomization endoscopy.
5. Pancreatic insufficiency/disease.
6. Active gastric erosions or gastric/duodenal ulcer.
7. History of gastroparesis or symptoms that would be suggestive of gastroparesis.
8. Pregnancy or plans of pregnancy in the next 12 months.
9. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
10. History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
11. History or present use of insulin or insulin derivatives for treatment of diabetes
12. Type II Diabetes Mellitus (as defined by HgbA1c \>6.5%) for greater than 10 years at the time of enrollment
13. Quit smoking within the last 6 months at time of enrollment or plans to quit smoking in the year after enrollment
14. Portal hypertension and/or varices.
15. Gastric outlet obstruction or stenosis.
16. Significant abnormality identified during Visit 2 (randomization visit) with endoscopy revealing large hiatal hernia, gastric ulcer, gastric erosions, etc.
17. Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
18. Beck Depression Inventory (Short) Score ≥12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment.
19. Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment.
20. Non-ambulatory or has significant impairment of mobility.
21. Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.
22. Participating in another clinical study.
23. Is a relative of investigator or his/her staff, or is employed by investigator or institution involved in the study.
24. Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
22 Years
60 Years
ALL
No
Sponsors
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USGI Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Tom Lavin, MD
Role: PRINCIPAL_INVESTIGATOR
Crescent City Surgical Center
Locations
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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
Countries
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References
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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.
Other Identifiers
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G130163
Identifier Type: -
Identifier Source: org_study_id
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