Clinical trial NCT00721227: Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
Official title: Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2008-07-24
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 subject understands and agrees to the procedure will be asked to sign a written informed consent (the ICD).
* Subjects will undergo reduction gastroplasty by gastric plication in which a section of the stomach will be infolded by multiple rows of sutures.
* Subjects are followed for 12 months to evaluate outcomes and potential complications.

Eligibility criteria: Inclusion Criteria:

Subjects are considered appropriate candidates for the study if they fulfill the following criteria:

1. Subject is willing to give consent and comply with evaluation and treatment schedule;
2. 21 to 60 years of age (inclusive);
3. 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);
4. Candidate for surgical weight loss intervention (i.e., meets ASMBS24 and NIH criteria);
5. 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
6. 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 Criteria:

Subjects will be excluded from the study for any of the following:

1. Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
2. Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
3. Previous mal-absorptive or restrictive procedures performed for the treatment of obesity;
4. Scheduled concurrent surgical procedure;
5. Participation in any other investigational device or drug study (non survey based trial) within 12 weeks of enrollment;
6. Any condition which precludes compliance with the study, including:

   1. 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;
   2. Congenital or acquired anomalies of the GI tract, including atresias or stenosis;
   3. Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate;
   4. Uncontrolled hypertension;
   5. Portal hypertension;
   6. Treatment with insulin (more than 50 units a day);
   7. Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices);
   8. Cirrhosis;
   9. Congenital or acquired intestinal telangiectasia;
   10. Esophageal or gastric disorders including moderate severe preoperative reflux, dysmotility, or Barrett's esophagus;
   11. Presence of hiatal hernia;
   12. Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery;
   13. Pancreatitis;
   14. Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
   15. Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study;
7. History or presence of pre-existing autoimmune connective tissue disease;
8. 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.

Primary outcomes:
measure: Successful Gastric Plication Using Reduction Gastroplasty
timeFrame: Immediately post-operative
Secondary outcomes:
measure: Durability of Gastric Plications Following Reduction Gastroplasty
timeFrame: 12 month
measure: Weight Loss Following Reduction Gastroplasty
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Philip R Schauer, M.D
role: PRINCIPAL_INVESTIGATOR
References: