TIPS Microspheres for Perianal Fistula

NCT03707769 | Completed DMC

• 1 other identifier: 14/0845
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perianal Fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical evidence of fistula healing

  9 months after device implantation

Study Arms (1)

Fistula treatment

EXPERIMENTAL

Treatment of fistula with TIPS microspheres

Device: TIPS microspheres

Interventions

TIPS microspheres DEVICE

TIPS microspheres manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) prepared as a paste with GranuGel.

Fistula treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and above
• Cryptoglandular perianal fistula
• High and low simple trans-sphincteric fistula

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator

Study Sites (1)

University College London Hospitals

London, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 16, 2018
• Study Start: March 15, 2017
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)