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Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00911989
First received: May 31, 2009
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

The main objective of this trial is to evaluate endoscopic visualization during a laparoscopic sleeve gastrectomy (LSG) procedure using an endoscope inserted transvaginally through a new device called a Steerable Flex Trocar (SFT).


Condition Intervention
Morbid Obesity
Device: NOTES toolbox

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Visualization During a Laparoscopic Sleeve Gastrectomy Procedure

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Proportion of Procedures Completed With Successful Endoscopic Visualization. [ Time Frame: Assessed intra-operatively ] [ Designated as safety issue: No ]
    The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded.


Enrollment: 4
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Transvaginal Sleeve Gastrectomy
Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
Device: NOTES toolbox
Using SFT for endoscope access during Transvaginal Sleeve Gastrectomy procedure. Visualization will occur through endoscope

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Women will be enrolled in this study who:

  • Are willing to give consent and comply with evaluation and treatment schedule;
  • Are 21 to 60 years of age (inclusive), post menopausal, or otherwise no longer expect to bear children, e.g., previous tubal ligation;
  • Are a candidate for surgical weight loss intervention (meets ASMBS and NIH criteria);
  • Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations;
  • 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;
  • Are American Society of Anesthesiologists (ASA) Class I, II, or III); and
  • Have a negative pregnancy test (for women of childbearing potential).

Exclusion Criteria

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

  • Previous pelvic surgery other than transverse C-sections and/or tubal ligation;
  • Enlarged uterus;
  • Evidence of pelvic malignancy on a screening ultrasound;
  • Documented history of drug and/or alcohol abuse within 2 years of the Screening Visit;
  • Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
  • Unable or unwilling to attend follow-up visits and examinations;
  • Planned or predicted concurrent surgical procedure;
  • Any medical condition which precludes compliance with the study;
  • 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, e.g., systemic lupus erythematosus or scleroderma;
  • Use of prescription or over the counter weight reduction medications or supplements, participation in weight-loss programs, or change in smoking habits within 8 weeks of the Screening Visit and for the duration of study participation;
  • Participation in another clinical trial within 8 weeks of the Screening Visit and for the duration of this trial (unless previously approved by the investigator and Sponsor); or
  • Any condition which precludes compliance with the study (investigator discretion).
  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: NCT00911989

Locations
United States, Ohio
Riverside Hospital
Columbus, Ohio, United States, 43214
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
Principal Investigator: Stephan Myers, MD, FACS Riverside Methodist Hospital
  More Information

No publications provided

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00911989     History of Changes
Other Study ID Numbers: CI-08-0008
Study First Received: May 31, 2009
Results First Received: October 4, 2011
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ethicon Endo-Surgery:
Obesity
Weight Loss

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014