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
  Purpose

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


Condition Intervention
Obesity
Procedure: Reduction Gastroplasty

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 15
Study Start Date: April 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anterior Curve
Reduction Gastroplasty by Gastric Plication on Anterior Curve
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: Greater Curve
Reduction Gastroplasty by Gastric Plication on Greater Curve
Procedure: Reduction Gastroplasty
  • Subjects will undergo reduction gastroplasty by gastric plication
  • Subjects are followed for 12 months to evaluate outcomes and potential complications.

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

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00721227

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
Principal Investigator: Philip R Schauer, M.D The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Amy Mahanes, Senior Clinical Research Associate, Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00721227     History of Changes
Other Study ID Numbers: CI-07-0005
Study First Received: July 9, 2008
Results First Received: July 21, 2010
Last Updated: September 1, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014