A Feasibility Study of a Fecal Incontinence Management System for Medical Use

This study has been terminated.

(Due to numerous delays in study start-up process...)

Sponsor:

Information provided by (Responsible Party):

Coloplast A/S

ClinicalTrials.gov Identifier:

NCT00556972

First received: November 9, 2007

Last updated: November 29, 2012

Last verified: November 2012

History of Changes

Results First Received: August 2, 2011

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Supportive Care
Condition:	Fecal Incontinence
Intervention:	Device: Fecal Incontinence Management System

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
Fecal Incontinence Management System	The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.

Participant Flow: Overall Study

	Fecal Incontinence Management System
STARTED	4
COMPLETED	4
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Fecal Incontinence Management System	The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.

Baseline Measures

	Fecal Incontinence Management System
Number of Participants [units: participants]	4
Age [units: participants]
<=18 years	0
Between 18 and 65 years	2
>=65 years	2
Age [units: years] Mean ± Standard Deviation	62.0 ± 14.2
Gender [units: participants]
Female	3
Male	1
Region of Enrollment [units: participants]
United States	4

Outcome Measures

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1. Primary:

The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed) [ Time Frame: 5 days ]

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2. Secondary:

Is the Barrier Size and Shape Satisfactory [ Time Frame: Subjects were followed for the duration of the study, an average of 23 hours ]

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3. Secondary:

Assessment of Skin 0-2 Inches From the Edge of the Anus [ Time Frame: Subjects were evaluated before and after test ]

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4. Secondary:

What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? [ Time Frame: After application of product ]

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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
No overall conclusions could be drawn, due to the limited amount of data (N=4 due to delays and low recruitment rate). A new study, with a higher sample size needs to be executed, if the objectives set in this study are to be investigated thoroughly.

Results Point of Contact:

Name/Title: Thais Benjamin N. Christensen, Senior Clinical Project Manager
Organization: Coloplast A/S
phone: +4549112668
e-mail: dkthc@coloplast.com

No publications provided

Responsible Party:	Coloplast A/S
ClinicalTrials.gov Identifier:	NCT00556972 History of Changes
Other Study ID Numbers:	DK172OS
Study First Received:	November 9, 2007
Results First Received:	August 2, 2011
Last Updated:	November 29, 2012
Health Authority:	United States: Institutional Review Board

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