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.
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: Within 9 months of device implantation