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Due to numerous delays in study start-up process...
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Incontinence Management System | Device | The device is intended to remedy fecal incontinence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed) | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Is the Barrier Size and Shape Satisfactory | Percentage of subjects who answered yes to the question: 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thais Benjamin N. Christensen, M.Sc. (BME) | Coloplast A/S | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center, Inc. | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed) | ITT | Posted | Mean | Standard Deviation | Hours | 5 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thais Benjamin N. Christensen, Senior Clinical Project Manager | Coloplast A/S | +4549112668 | dkthc@coloplast.com |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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. |
| 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Is the Barrier Size and Shape Satisfactory | Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory | ITT | Posted | Number | Percentage of subjects | Subjects were followed for the duration of the study, an average of 23 hours |
|
|
|
| Secondary | 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. | ITT | Posted | Mean | Standard Deviation | Scores on a scale | Subjects were evaluated before and after test |
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| Secondary | What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? | Posted | Number | Pouche and Bag | After application of product | Pouch and bag | Pouch and bag |
|
|
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| 0 |
| 4 |
| 0 |
| 4 |
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| Title | Measurements |
|---|---|
|
| Easy |
|
| Very Easy |
|