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Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication

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ClinicalTrials.gov Identifier: NCT01077193
Recruitment Status : Terminated (Study was terminated due to commercial considerations and potential patient attrition at 3 years. There were no patient safety or procedure efficacy reasons.)
First Posted : March 1, 2010
Results First Posted : September 13, 2013
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Tracking Information
First Submitted Date  ICMJE February 25, 2010
First Posted Date  ICMJE March 1, 2010
Results First Submitted Date  ICMJE July 9, 2013
Results First Posted Date  ICMJE September 13, 2013
Last Update Posted Date February 7, 2014
Study Start Date  ICMJE November 2009
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward [ Time Frame: 3 years ]
Percent excess weight change from baseline to 3 years was calculated as (the baseline weight minus the weight at 3 years) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects. One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss value of 41.1%EWL
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2010)
Percent excess weight loss (EWL) [ Time Frame: 3 years ]
One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss value of 41.1%EWL
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
Official Title  ICMJE Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
Brief Summary Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Morbid Obesity
Intervention  ICMJE Procedure: Gastric Plication

A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.

The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.

At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.

Study Arms  ICMJE Gastric Plication Surgery
Intervention: Procedure: Gastric Plication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 1, 2012)
44
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2010)
45
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is willing to give consent and comply with evaluation and treatment schedule (for female patients, this includes agreement to use a reliable (per investigator) form of birth control for the duration of the trial);
  2. 18 to 65 years of age (inclusive);
  3. Subject meets ASMBS and NIH criteria: (consensus.nih.gov)

    BMI ³ 40 kg/m2 and £ 50 kg/m2; or, BMI 35-40 kg/m2 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss, including:

    • Hyperlipidemia
    • Mild obstructive sleep apnea (per Investigator discretion)
    • Hypertension
    • Osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated;
  4. ASA Class I - III;
  5. Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective procedure that would affect body weight for the duration of the trial;
  6. HbA1C < 11%; and
  7. For subjects who have Type 2 diabetes, medication regimen is no more complex (2 oral medications) than oral metformin plus one oral sulfonylurea plus once daily insulin injection.

Exclusion Criteria:

  1. Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
  2. Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
  3. Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
  4. Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
  5. Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts;
  6. Participation in any other investigational device or drug study (non-survey based trial; long-term enrollment in such studies as requiring periodic laboratory tests, etc., would be allowed) within 12 weeks of enrollment;
  7. 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. Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices);
    7. Cirrhosis;
    8. Congenital or acquired intestinal telangiectasia;
    9. Esophageal or gastric disorders including moderate severe preoperative reflux, dysmotility, or Barrett's esophagus;
    10. Presence of hiatal hernia greater than 2cm in length, with the exception of a small sliding hiatal hernia previously undiagnosed and discovered during the surgical procedure;
    11. Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery;
    12. Known history of clotting disorders, hemoglobinopathies, and hemolytic disorders, including pulmonary embolus and Deep Vein Thrombosis;
    13. Pancreatitis;
    14. Gallstones (confirmed via ultrasound);
    15. Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
    16. Use of thiazolidinediones ("glitazones"), or
    17. Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study;
  8. History or presence of pre-existing autoimmune connective tissue disease; and
  9. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   United States
Removed Location Countries Brazil
 
Administrative Information
NCT Number  ICMJE NCT01077193
Other Study ID Numbers  ICMJE CI-09-0006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ethicon Endo-Surgery
Study Sponsor  ICMJE Ethicon Endo-Surgery
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ethicon Endo-Surgery
Verification Date January 2014

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