Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates

This study has been completed.
Sponsor:
Information provided by:
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00721227
First received: July 9, 2008
Last updated: September 1, 2010
Last verified: September 2010

July 9, 2008
September 1, 2010
April 2008
March 2010   (final data collection date for primary outcome measure)
Successful Gastric Plication Using Reduction Gastroplasty [ Time Frame: Immediately post-operative ] [ Designated as safety issue: No ]
The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.
Gastric plication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00721227 on ClinicalTrials.gov Archive Site
  • Durability of Gastric Plications Following Reduction Gastroplasty [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    The number of participants who completed month 12 gastroscopies showing intact plications.
  • Weight Loss Following Reduction Gastroplasty [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of excess weight loss calculated at 12 months post-surgery. Percentage of excess weight loss is calculated is the difference in baseline and post-surgery weight divided by the difference in baseline weight and ideal body weight multiplied by 100.
Not Provided
Not Provided
Not Provided
 
Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates

This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
Procedure: Reduction Gastroplasty
  • Subjects will undergo reduction gastroplasty by gastric plication
  • Subjects are followed for 12 months to evaluate outcomes and potential complications.
  • Active Comparator: Anterior Curve
    Reduction Gastroplasty by Gastric Plication on Anterior Curve
    Intervention: Procedure: Reduction Gastroplasty
  • Active Comparator: Greater Curve
    Reduction Gastroplasty by Gastric Plication on Greater Curve
    Intervention: Procedure: Reduction Gastroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
21 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721227
CI-07-0005
No
Amy Mahanes, Senior Clinical Research Associate, Ethicon Endo-Surgery
Ethicon Endo-Surgery
Not Provided
Principal Investigator: Philip R Schauer, M.D The Cleveland Clinic
Ethicon Endo-Surgery
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP