Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization

NCT00911989 | Completed Results DMC

• 1 other identifier: CI-08-0008
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Morbid Obesity

Keywords

Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Proportion of Procedures Completed With Successful Endoscopic Visualization.

  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.

  Assessed intra-operatively

Study Arms (1)

Transvaginal Sleeve Gastrectomy

OTHER

Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)

Device: NOTES toolbox

Interventions

NOTES toolbox DEVICE

Using SFT for endoscope access during Transvaginal Sleeve Gastrectomy procedure. Visualization will occur through endoscope

Transvaginal Sleeve Gastrectomy

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (1)

Riverside Hospital

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Ethicon-Endo Surgery

SHelsing@its.jnj.com

1.513.337.3079

Study Officials

• Stephan Myers, MD, FACS

  Riverside Methodist Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2009
• First Posted: June 3, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 25, 2012
• Results First Posted: November 8, 2011

Record last verified: 2012-06

Locations

US (1)