Status:
COMPLETED
Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Obesity
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief Summary
This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention.
Detailed Description
The overall plan for all subjects consists of the following elements: * Subject will be informed about the nature of the research, given the Informed Consent Document (ICD) to read, and if the subjec...
Eligibility Criteria
Inclusion
- Subjects are considered appropriate candidates for the study if they fulfill the following criteria:
- Subject is willing to give consent and comply with evaluation and treatment schedule;
- 21 to 60 years of age (inclusive);
- BMI \> 35 kg/m2 and \< 50 kg/m2 (BMI 35-40 kg/m2 allowable with one or more significant medical conditions related to obesity, including co-morbid conditions of hyperlipidemia, mild obstructive sleep apnea (per Investigators discretion), hypertension, or osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated, and which are generally expected to be improved, reversed, or resolved by weight loss);
- Candidate for surgical weight loss intervention (i.e., meets ASMBS24 and NIH criteria);
- Absence of significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, per site standard of care (SOC); and
- Agree to refrain from any type of elective procedures that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for the duration of the trial.
Exclusion
- Subjects will be excluded from the study for any of the following:
- Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
- Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
- Previous mal-absorptive or restrictive procedures performed for the treatment of obesity;
- Scheduled concurrent surgical procedure;
- Participation in any other investigational device or drug study (non survey based trial) within 12 weeks of enrollment;
- Any condition which precludes compliance with the study, including:
- Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years;
- Congenital or acquired anomalies of the GI tract, including atresias or stenosis;
- Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate;
- Uncontrolled hypertension;
- Portal hypertension;
- Treatment with insulin (more than 50 units a day);
- Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices);
- Cirrhosis;
- Congenital or acquired intestinal telangiectasia;
- Esophageal or gastric disorders including moderate severe preoperative reflux, dysmotility, or Barrett's esophagus;
- Presence of hiatal hernia;
- Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery;
- Pancreatitis;
- Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
- Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study;
- History or presence of pre-existing autoimmune connective tissue disease;
- Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00721227
Start Date
April 1 2008
End Date
March 1 2010
Last Update
September 8 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195