The USGI Medical ESSENTIAL Study for Weight Loss

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
USGI Medical
ClinicalTrials.gov Identifier:
NCT01958385
First received: October 4, 2013
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Obesity
Device: placement of g-Cath EZ suture anchors
Procedure: Sham procedure
Behavioral: Diet and Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS

Resource links provided by NLM:


Further study details as provided by USGI Medical:

Primary Outcome Measures:
  • Total Body Weight Loss [ Time Frame: Enrollment to 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Quality of Life scores (IWQOL) [ Time Frame: enrollment to 12 months ] [ Designated as safety issue: No ]
    Assessment of changes

  • Comorbid status [ Time Frame: Enrollment to 12 months ] [ Designated as safety issue: No ]
    Assessment of changes from baseline at 12 months in hypertension, diabetes, and hyperlipidemia

  • Eating Behavior changes [ Time Frame: Enrollment to 12 months ] [ Designated as safety issue: No ]
    assessment of changes from baseline at 12 months in eating behavior scores (TFEQ) and subjective changes in food capacity, hunger, and satiety in both study groups


Estimated Enrollment: 377
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment group
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
Other Name: g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical)
Behavioral: Diet and Exercise
A structured diet and exercise plan
Sham Comparator: Sham Group
The treatment of obese patients with the sham procedure along with Diet and Exercise
Procedure: Sham procedure Behavioral: Diet and Exercise
A structured diet and exercise plan

  Eligibility

Ages Eligible for Study:   22 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent.
  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:

  1. History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958385

Locations
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Florida
DeWitt Daughtry Family Department of Surgery University of Miami Miller School of Medicine
Miami, Florida, United States, 33166
United States, Georgia
Hamilton Medical Center
Dalton, Georgia, United States, 30722
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
United States, Louisiana
Crescent City Surgical Centre
Covington, Louisiana, United States, 70433
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02120
United States, Minnesota
University of MN, Fairview Health Services
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, South Carolina
Lexington Medical Center
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Baptist Memorial
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
USGI Medical
Investigators
Principal Investigator: Tom Lavin, Dr. Crescent City Surgical Center
  More Information

No publications provided

Responsible Party: USGI Medical
ClinicalTrials.gov Identifier: NCT01958385     History of Changes
Other Study ID Numbers: G130163
Study First Received: October 4, 2013
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by USGI Medical:
Total Body Weight Loss

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 26, 2014