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

NCT00556972 | Terminated Results

• 1 other identifier: DK172OS
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)

  5 days

Secondary Outcomes (3)

• Is the Barrier Size and Shape Satisfactory

  Subjects were followed for the duration of the study, an average of 23 hours

• Assessment of Skin 0-2 Inches From the Edge of the Anus

  Subjects were evaluated before and after test

• What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?

  After application of product

Study Arms (1)

Fecal Incontinence management system

EXPERIMENTAL

Fecal Incontinence Management System is based on the same principle as fecal pouches. A barrier around anus to ensure adhesion and prevent leakage.

Device: Fecal Incontinence Management System

Interventions

Fecal Incontinence Management System DEVICE

The device is intended to remedy fecal incontinence.

Fecal Incontinence management system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is at least 18 years of age
• The subject has fecal incontinence

You may not qualify if:

• The subject is pregnant and/or breastfeeding
• The subject has perianal fistulas and/or hemorrhoids
• It's estimated that the subject's perianal skin makes it inappropriate for subject to participate in the study (i.e. in case of damaged skin, very sweaty skin or very sinuous and folded skin)

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Beth Israel Deaconess Medical Center, Inc.

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

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

• Title: Thais Benjamin N. Christensen, Senior Clinical Project Manager
• Organization: Coloplast A/S

dkthc@coloplast.com

+4549112668

Study Officials

• Thais Benjamin N. Christensen, M.Sc. (BME)

  Coloplast A/S

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: January 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 6, 2022
• Results First Posted: January 1, 2013

Record last verified: 2022-11

Locations

US (1)