TIPS Microspheres for Perianal Fistula

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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First-in-human Open Label Feasibility Study to Assess the Safety of TIPS Microspheres in Perianal Fistulas

Conditions
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Perianal Fistula

Intervention / Treatment
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* Device: TIPS microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and above Cryptoglandular perianal fistula High and low simple trans-sphincteric fistula Exclusion Criteria: Secondary fistula, including Crohn's disease, carcinoma, radiotherapy, tuberculosis Evidence of branching fistula anatomy or cavity on MRI Inter-sphincteric fistula Low trans-phincterictrans-sphincteric fistula amenable to simple fistulotomy Immunosuppressed patients Participants less than 18 years of age Unable to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fistula treatment<br>Treatment of fistula with TIPS microspheres | Device: TIPS microspheres<br>* TIPS microspheres manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) prepared as a paste with GranuGel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |