Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization

NCT ID: NCT00911989

Last Updated: 2012-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transvaginal Sleeve Gastrectomy

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

Group Type: OTHER

NOTES toolbox

Intervention Type: DEVICE

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

Interventions

NOTES toolbox

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

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Myers, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Riverside Methodist Hospital

Locations

Riverside Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

CI-08-0008

Identifier Type: -

Identifier Source: org_study_id