Fecal IncontinenceNCT00556972
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
A study testing Fecal Incontinence Management System in people with Fecal Incontinence, run by Coloplast A/S at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Fecal Incontinence Management System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is at least 18 years of age
- The subject has fecal incontinence
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center, Inc.
Boston, Massachusetts, 02215
About this study
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.
Read the detailed description
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
- Being tested
- Fecal Incontinence Management System
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Incontinence Management SystemDevice
The device is intended to remedy fecal incontinence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fecal Incontinence Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)
Measured: 5 days
Secondary outcomes (3)
Is the Barrier Size and Shape Satisfactory
Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory
Measured: 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
Skin condition scale: 1 = Normal skin without redness, 2 = Normal redness and intact skin, 3 = Abnormal redness but intact skin, 4 = Red and spotted but intact skin, 5 = Red and broken skin, 6 = Broken and bleeding skin Best skin condition score is 1, and worst skin condition score is 6.
Measured: Subjects were evaluated before and after test
What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
Measured: After application of product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Due to numerous delays in study start-up process...
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thais Benjamin N. Christensen, M.Sc. (BME), Study chair, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556972
- Sponsor's protocol ID
- DK172OS
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2007
- Last updated
- 6 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Fecal Incontinence Management System for Medical Use
- ClinicalTrials.gov ID
- NCT00556972
- Acronym / sponsor ID
- DK172OS
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to numerous delays in study start-up process...
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Posted 1 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Incontinence management system | Experimental | Device: Fecal Incontinence Management SystemFecal Incontinence Management System is based on the same principle as fecal pouches. A barrier around anus to ensure adhesion and prevent leakage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject is at least 18 years of age
- The subject has fecal incontinence
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Incontinence Management SystemThe device is intended to remedy fecal incontinence. | Device | Fecal Incontinence management system |
Primary outcome
The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)
Time frame: 5 days
3 secondary outcomes
Is the Barrier Size and Shape Satisfactory
Time frame: 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
Time frame: Subjects were evaluated before and after test
What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
Time frame: After application of product
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thais Benjamin N. Christensen, M.Sc. (BME) study chair
Coloplast A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Incontinence Management System in people with Fecal Incontinence, run by Coloplast A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed) (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.