Status:
COMPLETED
ESSENTIAL Trial™ Sham Cross-over
Lead Sponsor:
USGI Medical
Conditions:
Obesity
Eligibility:
All Genders
23-61 years
Phase:
NA
Brief Summary
This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE...
Detailed Description
This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE...
Eligibility Criteria
Inclusion
- Provide written informed consent.
- Potential subject was sham participant in the Essential pivotal trial
- Potential subject agrees to be compliant with study and has a documented history of compliance in pivotal study.
- Subjects between the ages of 23-61 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 ≥30 and \<35 with at least one non-severe co-morbid obesity related condition or a BMI ≥ 35 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 (See Section 14)
- 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.
- Agrees not to utilize any prescription or over the counter weight loss medications OR those that can suppress appetite/induce weight loss for 12 months following study enrollment (including all stimulant medication).
- Be willing to cooperate with post-operative dietary recommendations and assessment tests.
- Residing 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
- 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 or procedure execution.
- 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 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.
- 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 11 years at the time of enrollment
- If smoker, plans to quit smoking in the year after enrollment
- Portal hypertension and/or varices.
- Significant abnormality identified during Visit 2 (enrollment visit) with endoscopy revealing large hiatal hernia, gastric/duodenal ulcer, gastric erosions, gastric outlet obstruction or stenosis, etc.
- Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
- 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 including untreated hypothyroidism (TSH \>5.0 U/ml).
- Participating in another clinical study except for Essential 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.
Key Trial Info
Start Date :
January 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2016
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT02279420
Start Date
January 5 2015
End Date
September 30 2016
Last Update
May 12 2017
Active Locations (11)
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1
Shea Campus -Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
2
University of Miami Hospital
Miami, Florida, United States, 33166
3
Hamilton Medical Center
Dalton, Georgia, United States, 30720
4
Northshore/Evanston Hospital
Evanston, Illinois, United States, 60201