Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates

This study has been completed.

Study NCT00721227 Information provided by Ethicon Endo-Surgery

First Received on July 9, 2008. Last Updated on September 1, 2010 History of Changes

Results First Received: July 21, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Obesity
Intervention:	Procedure: Reduction Gastroplasty

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
Enrollment period started April 17, 2008. Enrollment continued until December 31, 2008. The followup period continued until January 29, 2010. Enrollment was conducted in the bariatric and research offices of The Cleveland Clinic Foundation, Cleveland, Ohio.

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
Anterior Curve	Reduction Gastroplasty by Gastric Plication on Anterior Curve
Greater Curve	Reduction Gastroplasty by Gastric Plication on Greater Curve

Participant Flow: Overall Study

	Anterior Curve	Greater Curve
STARTED	9	6
COMPLETED	5 ^[1]	6
NOT COMPLETED	4	0
Lost to Follow-up	3	0
Noncompliance with scheduled visits.	1	0

[1]	3 subjects lost to follow up; 1 subject did not complete due to noncompliance of scheduled visits.

Baseline Characteristics

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Reporting Groups

	Description
Anterior Curve	Reduction Gastroplasty by Gastric Plication on Anterior Curve
Greater Curve	Reduction Gastroplasty by Gastric Plication on Greater Curve

Baseline Measures

	Anterior Curve	Greater Curve	Total
Number of Participants [units: participants]	9	6	15
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	9	6	15
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	45.0 ± 10.37	36.8 ± 8.42	41.7 ± 10.19
Gender [units: participants]
Female	6	6	12
Male	3	0	3
Region of Enrollment [units: participants]
United States	9	6	15

Outcome Measures

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1. Primary:

Successful Gastric Plication Using Reduction Gastroplasty [ Time Frame: Immediately post-operative ]

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2. Secondary:

Durability of Gastric Plications Following Reduction Gastroplasty [ Time Frame: 12 month ]

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3. Secondary:

Weight Loss Following Reduction Gastroplasty [ Time Frame: 12 months ]

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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 NOT 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.

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: Amy Mahanes, Senior Clinical Research Associate
Organization: Ethicon Endo Surgery, Inc.
phone: 513-337-8366
e-mail: amahanes@its.jnj.com

No publications provided

Responsible Party:	Amy Mahanes, Senior Clinical Research Associate, Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:	NCT00721227 History of Changes
Other Study ID Numbers:	CI-07-0005
Study First Received:	July 9, 2008
Results First Received:	July 21, 2010
Last Updated:	September 1, 2010
Health Authority:	United States: Institutional Review Board