NCT03707769

TIPS Microspheres for Perianal Fistula

Completed NA Last updated 28 November 2025

What this trial tests

NA trial testing TIPS microspheres in Perianal Fistula in 13 participants. Completed in 31 October 2025.

Timeline

15 March 2017

Primary endpoint
31 October 2025

31 October 2025

Quick facts

Lead sponsor	University College, London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	13
Start date	15 March 2017
Primary completion	31 October 2025
Estimated completion	31 October 2025
Sites	1 location across United Kingdom

Drugs / interventions tested

• TIPS microspheres

Conditions studied

• Perianal Fistula — all drugs for Perianal Fistula →

Sponsor

University College, London

Who can join

18 and older, any sex, with Perianal Fistula. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. PLGA-Based Nanomedicine: History of Advancement and Development in Clinical Applications of Multiple Diseases.
   Alsaab HO, Alharbi FD, Alhibs AS, Alanazi NB, et al · · 2022 · cited 141× · PMID 36559223 · DOI 10.3390/pharmaceutics14122728
2. CT-Visible Microspheres Enable Whole-Body In Vivo Tracking of Injectable Tissue Engineering Scaffolds.
   Bettini A, Patrick PS, Day RM, Stuckey DJ. · · 2024 · cited 5× · PMID 38678393 · DOI 10.1002/adhm.202303588
3. Hierarchically Structured Biodegradable Microspheres Promote Therapeutic Angiogenesis.
   Hendow EK, Iacoviello F, Casajuana Ester M, Pellet-Many C, et al · · 2024 · cited 1× · PMID 39258380 · DOI 10.1002/adhm.202401832