Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ethicon Endo-Surgery

ClinicalTrials.gov Identifier:

NCT00911989

First received: May 31, 2009

Last updated: June 19, 2012

Last verified: June 2012

History of Changes

Results First Received: October 4, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Morbid Obesity
Intervention:	Device: NOTES toolbox

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Transvaginal Sleeve Gastrectomy	Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)

Participant Flow: Overall Study

	Transvaginal Sleeve Gastrectomy
STARTED	4
COMPLETED	3
NOT COMPLETED	1
Adverse Event	1

Baseline Characteristics

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Reporting Groups

	Description
Transvaginal Sleeve Gastrectomy	Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)

Baseline Measures

	Transvaginal Sleeve Gastrectomy
Number of Participants [units: participants]	4
Age [units: participants]
<=18 years	0
Between 18 and 65 years	4
>=65 years	0
Age [units: years] Mean ± Standard Deviation	48.3 ± 11.64
Gender [units: participants]
Female	4
Male	0
Region of Enrollment [units: participants]
United States	4

Outcome Measures

1. Primary:

Proportion of Procedures Completed With Successful Endoscopic Visualization. [ Time Frame: Assessed intra-operatively ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Director of Clinical Operations
Organization: Ethicon-Endo Surgery
phone: 1.513.337.3079
e-mail: SHelsing@its.jnj.com

No publications provided

Responsible Party:	Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:	NCT00911989 History of Changes
Other Study ID Numbers:	CI-08-0008
Study First Received:	May 31, 2009
Results First Received:	October 4, 2011
Last Updated:	June 19, 2012
Health Authority:	United States: Food and Drug Administration

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