Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization

• Sponsor: Ethicon Endo-Surgery (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00911989
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arm: 1
• Duration (Months): 17
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Device: NOTES toolbox	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Endoscopic Visualization During a Laparoscopic Sleeve Gastrectomy Procedure
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Transvaginal Sleeve Gastrectomy Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)	Device: NOTES toolbox; Using SFT for endoscope access during Transvaginal Sleeve Gastrectomy procedure. Visualization will occur through endoscope

Outcome Measures

Primary Outcome Measures

1. Proportion of Procedures Completed With Successful Endoscopic Visualization. [Assessed intra-operatively]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riverside Hospital	Columbus	Ohio	United States	43214

Sponsors and Collaborators

• Ethicon Endo-Surgery

Investigators

• Principal Investigator: Stephan Myers, MD, FACS, Riverside Methodist Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ethicon Endo-Surgery
• ClinicalTrials.gov Identifier: NCT00911989
• Other Study ID Numbers: CI-08-0008
• First Posted: Jun 3, 2009
• Last Update Posted: Jun 25, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Ethicon Endo-Surgery: Obesity; Weight Loss
• Additional relevant MeSH terms: Obesity, Morbid

Study Results

Participant Flow

Arm/Group Title	Transvaginal Sleeve Gastrectomy
Arm/Group Description	Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
Period Title: Overall Study
STARTED	4
COMPLETED	3
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Transvaginal Sleeve Gastrectomy
Arm/Group Description	Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
Overall Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.3 (11.64)
Sex: Female, Male (Count of Participants)
Female	4 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Procedures Completed With Successful Endoscopic Visualization.
Description	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.
Time Frame	Assessed intra-operatively

Outcome Measure Data

Analysis Population Description

All subjects on whom the surgery was attempted represent the primary analysis population.

Arm/Group Title	Transvaginal Sleeve Gastrectomy
Arm/Group Description	All subjects on whom the surgery was attempted.
Measure Participants	4
Number [participants]	4 100%

Adverse Events

Time Frame	Adverse events collected from informed consent date to 12 months post surgery.
Arm/Group Title	Transvaginal Sleeve Gastrectomy
Arm/Group Description	Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
All Cause Mortality
	Transvaginal Sleeve Gastrectomy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Transvaginal Sleeve Gastrectomy
	Affected / at Risk (%)	# Events
Total	1/4 (25%)
Injury, poisoning and procedural complications
Gastrointestinal disorder postoperative	1/4 (25%)	1
Other (Not Including Serious) Adverse Events
	Transvaginal Sleeve Gastrectomy
	Affected / at Risk (%)	# Events
Total	4/4 (100%)
Gastrointestinal disorders
Abnormal faeces	1/4 (25%)	1
Epigastric discomfort	1/4 (25%)	1
Nausea	3/4 (75%)	4
Oesophageal pain	1/4 (25%)	1
General disorders
Chest discomfort	1/4 (25%)	1
Injury, poisoning and procedural complications
Incision site pain	1/4 (25%)	1
Post procedural complications	1/4 (25%)	1
Post procedural haemorrhage	2/4 (50%)	2
Procedural nausea	1/4 (25%)	1
Procedural pain	3/4 (75%)	4
Procedural vomiting	1/4 (25%)	1
Nervous system disorders
Lethargy	1/4 (25%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.