Status:
COMPLETED
Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Morbid Obesity
Eligibility:
FEMALE
21-60 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00911989
Start Date
July 1 2009
End Date
December 1 2010
Last Update
June 25 2012
Active Locations (1)
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1
Riverside Hospital
Columbus, Ohio, United States, 43214