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Completed

NCT Number: NCT03707769

TIPS Microspheres for Perianal Fistula

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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Key information

Conditions

Perianal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London Hospitals

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIPS microspheres

Device

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

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Within 9 months of device implantation

    Safety as defined by morbidity, measured by occurrence of adverse events / reactions, in particular: perianal sepsis, perianal abscess, or reoperation due to sepsis

Secondary outcomes

  1. Clinical evidence of fistula healing

    Time frame: 9 months after device implantation

    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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • University College London Hospitals

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2018
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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