Clinical trial NCT00911989: Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization
Official title: Endoscopic Visualization During a Laparoscopic Sleeve Gastrectomy Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Obesity
Weight Loss
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 4
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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).

Primary outcomes:
measure: Proportion of Procedures Completed With Successful Endoscopic Visualization.
timeFrame: Assessed intra-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Riverside Hospital
state: Ohio
Study officials:
affiliation: Riverside Methodist Hospital
name: Stephan Myers, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: