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| Name | Class |
|---|---|
| University College London Hospitals | OTHER |
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Phase of Investigation: First-in-human feasibility study
Objectives: Primary objective: Demonstration that TIPS microspheres do not compromise the clinical condition or safety of the patient.
Secondary objective: To demonstrate that TIPS microspheres facilitate natural healing in the context of perianal fistula.
Type of Investigation: First-in-human single site, open label, feasibility study to assess the safety of TIPS microspheres in perianal fistulas and indicative functionality.
Investigation design and methods: First-in-human single delivery of a bioabsorbable device to treat perianal fistula. A standard of care internal flap procedure performed to close the internal fistula opening and up to 300 mg of TIPS microspheres will be inserted into each perianal fistula. Participants will be assessed for healing, inflammation, abscess, sepsis, pain and continence by clinical assessments, blood tests, MRI and questionnaires.
TIPS microspheres are manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) under Good Laboratory Practice (GLP) conditions.
Microspheres will be delivered into the fistula tract using the following procedure:
i) Tract identification with special emphasis on locating the internal and external openings using a fistula probe.
ii) Curettage to remove epithelium lining the tract and cleaning by irrigation with hydrogen peroxide and saline.
iii) Closure of the internal opening by means of a rectoanal advancement flap. iv) Following device kit instructions, prepare a paste of TIPS microspheres with GranuGel.
v) Introduction of TIPS microsphere paste by back-filling. vi) Retention of the microsphere paste using Comfeel adhesive hydrocolloid dressing designed to remain in place for 1 - 14 days.
Each subject will receive a single administration of up to 300 mg of TIPS microspheres implanted into the fistula tract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fistula treatment | Experimental | Treatment of fistula with TIPS microspheres |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIPS microspheres | Device | TIPS microspheres manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) prepared as a paste with GranuGel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Safety as defined by morbidity, measured by occurrence of adverse events / reactions, in particular: perianal sepsis, perianal abscess, or reoperation due to sepsis | Within 9 months of device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evidence of fistula healing | Efficacy through facilitation of natural healing as determined by: clinical evidence of fistula healing; MRI evidence of fistula healing; improvement of quality of life assessment Improvement of pain score assessment | 9 months after device implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospitals | London | United Kingdom |
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