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| ID | Type | Description | Link |
|---|---|---|---|
| 350012 |
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This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vesico-vaginal fistula plug | Experimental | Vesico-vaginal fistula plug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgisis Biodesign (Vesico-vaginal fistula plug) | Device | Vesico-vaginal fistula plug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fistula | 4 months | |
| Adverse Events | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in quality of life | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Musa Kayondo, MD | Mbarara University Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mbarara University Teaching Hospital | Mbarara | Uganda |
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| ID | Term |
|---|---|
| D014719 | Vesicovaginal Fistula |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D014624 | Vaginal Fistula |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001747 | Urinary Bladder Fistula |
| D014548 | Urinary Fistula |
| D014564 | Urogenital Abnormalities |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D000091662 | Genital Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |