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

May 31, 2009
June 19, 2012
July 2009
December 2010   (final data collection date for primary outcome measure)
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.
The Primary Analysis is the Proportion of Procedures Completed Successfully With Endoscopic Visualization. [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00911989 on ClinicalTrials.gov Archive Site
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Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization
Endoscopic Visualization During a Laparoscopic Sleeve Gastrectomy Procedure

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).

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Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Morbid Obesity
Device: NOTES toolbox
Using SFT for endoscope access during Transvaginal Sleeve Gastrectomy procedure. Visualization will occur through endoscope
Transvaginal Sleeve Gastrectomy
Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
Intervention: Device: NOTES toolbox
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
December 2010
December 2010   (final data collection date for primary outcome measure)

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).
Female
21 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00911989
CI-08-0008
Yes
Ethicon Endo-Surgery
Ethicon Endo-Surgery
Not Provided
Principal Investigator: Stephan Myers, MD, FACS Riverside Methodist Hospital
Ethicon Endo-Surgery
June 2012

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