Using TIPS microspheres to treat perianal fistulas
First-in-human Open Label Feasibility Study to Assess the Safety of TIPS Microspheres in Perianal Fistulas
This study is testing if a new treatment using special microspheres can safely help heal perianal fistulas after a common surgical procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT03707769 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human feasibility study aimed at assessing the safety and functionality of TIPS microspheres in treating perianal fistulas. The study involves a single delivery of bioabsorbable microspheres into the fistula tract following a standard internal flap procedure to close the internal opening. Participants will be monitored for healing, inflammation, abscess, sepsis, pain, and continence through various clinical assessments and tests. The goal is to demonstrate that TIPS microspheres do not compromise patient safety and facilitate natural healing.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with cryptoglandular perianal fistulas.
Not a fit: Patients with secondary fistulas, such as those caused by Crohn's disease or other specific conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, effective treatment option for patients suffering from perianal fistulas.
How similar studies have performed: While this approach is novel, other studies have explored similar bioabsorbable devices, but this specific application is untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- University College London Hospitals — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Richard Day, PhD
- Email: r.m.day@ucl.ac.uk
- Phone: +442031082183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.