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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02787-34 | Other Identifier | IDRCB |
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The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SygeLIX-F + SygeLIX-G | Experimental | Combination of SygeLIX-F, a plug made of an assembly of umbilical cord lining and Wharton's jelly in the form of a cylinder of porous structure, and SygeLIX-G, a Wharton's jelly gel reconstituted in a syringe. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SygeLIX-F + SygeLIX-G | Biological | SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel). |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of intensity of perineal inflammation following treatment | Scoring of pain (0 = no pain, 10 = worst pain possible), redness (0 = no redness, 4 = redness covering an area > 5 cm), edema (0 = no edema, 4 = area completely swollen), ulceration (0 = no ulceration, 4 = ulcer larger than 1 cm). | Through study completion (45 days) |
| Rate of plug expulsion and surgical revision due to complications | Through study completion (45 days) | |
| Type and incidence of adverse events (AE) and serious adverse events (SAE) | Through study completion (45 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of surgical technique | Questionnaire on surgical technique including ease of plug suture to the mucosa and of gel use. | Time of investigational products surgical implantation (Day 0) |
| Plug integration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Blomet | Paris | 75015 | France | |||
| Maison de Santé Protestante de Bordeaux-Bagatelle |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Assessment of anal continence by the Vaizey score (0 = perfect continence, 24 = totally incontinent).
| 30 days, 45 days |
| Cessation of fistula flow | Healing of the fistula orifices assessed by palpation and pinching. | 45 days |
| Talence |
| 33401 |
| France |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |