Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization
June 19, 2012 updated by: Ethicon Endo-Surgery
Endoscopic Visualization During a Laparoscopic Sleeve Gastrectomy Procedure
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States, 43214
- Riverside Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Transvaginal Sleeve Gastrectomy
Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
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Using SFT for endoscope access during Transvaginal Sleeve Gastrectomy procedure.
Visualization will occur through endoscope
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Procedures Completed With Successful Endoscopic Visualization.
Time Frame: Assessed intra-operatively
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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.
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Assessed intra-operatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephan Myers, MD, FACS, Riverside Methodist Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
May 31, 2009
First Submitted That Met QC Criteria
June 2, 2009
First Posted (Estimate)
June 3, 2009
Study Record Updates
Last Update Posted (Estimate)
June 25, 2012
Last Update Submitted That Met QC Criteria
June 19, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CI-08-0008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.