Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization

Morbid Obesity Clinical Trial

Official title:

Endoscopic Visualization During a Laparoscopic Sleeve Gastrectomy Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911989
• Other study ID #: CI-08-0008
• Status: Completed
• Phase: N/A
• First received: May 31, 2009
• Last updated: June 19, 2012
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2012
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 60 Years

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• NOTES toolbox
Using SFT for endoscope access during Transvaginal Sleeve Gastrectomy procedure. Visualization will occur through endoscope

Locations

Country	Name	City	State
United States	Riverside Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No