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Study stopped early due to staffing changes at the site.
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| Name | Class |
|---|---|
| Cook Biotech Incorporated | INDUSTRY |
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Healing anal fistulas in Crohn's patients with an anal fistula plug.
The purpose of this study is to determine whether the Surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with Crohn's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFP | Experimental | Anal fistula plug placement performed during surgical procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP) | Device | Surgical placement of the Surgisis AFP is performed under general anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fistula Closure (Patient Based) | Fistula closure is defined as absence of drainage at the external fistula opening. | 12 months |
| Fistula Closure (Tract Based) | Fistula closure is defined as absence of drainage at the external fistula opening. An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Moore, MD | Colon & Rectal Surgeons of Southern California, Mt. Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Mount Sinai Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biodesign® Anal Fistula Plug | Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation. Three single tract fistula patients were lost to follow-up and were excluded from the analysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biodesign® Anal Fistula Plug | Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation. Three single tract fistula patients were lost to follow-up and were excluded from the analysis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Three single-tract fistula patients were lost to follow-up and were excluded from the analysis on age. |
| 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 | Fistula Closure (Patient Based) | Fistula closure is defined as absence of drainage at the external fistula opening. | Three single tract fistula patients were lost to follow-up and were excluded from the analysis. | Posted | Number | participants | 12 months |
|
|
12 months
Three single-tract fistula patients were lost to follow-up and were excluded from the analysis.
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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 | Biodesign® Anal Fistula Plug | Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation. Three single tract fistula patients were lost to follow-up and were excluded from the analysis. |
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Early termination did lead to small patient numbers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Hodde, Clinical Affairs Manager | Cook Biotech, Incorporated | 765-497-3355 | jhodde@CookBiotech.com |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| New York |
| New York |
| 10029 |
| United States |
| Univeristy Hospitals Medical Center | Cleveland | Ohio | 44106 | United States |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Three single-tract fistula patients were lost to follow-up and were excluded from the analysis on gender. | Count of Participants | Participants |
|
| Height | Three single-tract fistula patients were lost to follow-up and were excluded from the analysis on height. | Mean | Full Range | inches |
|
| Weight | Three single-tract fistula patients were lost to follow-up and were excluded from the analysis on weight. | Mean | Full Range | pounds |
|
| Body Mass Index | Three single-tract fistula patients were lost to follow-up and were excluded from the analysis on body mass index. | Mean | Full Range | kg/m^2 |
|
| Participants |
|
|
| Primary | Fistula Closure (Tract Based) | Fistula closure is defined as absence of drainage at the external fistula opening. An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient. | Three single tract fistula patients were lost to follow-up and were excluded from the analysis. | Posted | Number | tracts | 12 months | tracts | Participants |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
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| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |