TIPS microspheres for perianal fistula
Research type
Research Study
Full title
First in human feasibility study to assess the safety of TIPS microspheres in perianal fistulas
IRAS ID
191954
Contact name
Manish Chand
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Perianal fistulas are a connection between the anal canal and the skin surface creating an abnormal passageway for the discharge of bodily fluids. The goals of fistula treatment are to close the fistula after removing material from within that might cause infection, whilst trying to avoid damage to the surrounding tissue that could cause incontinence. A range of materials have been used to fill fistulas in an attempt to promote healing but many of these have failed because the material becomes dislodged and falls out or results in an infection. The use of highly porous microspheres might overcome this problem. When packed into a fistula the microspheres should provide a ‘scaffold’ that cells can easily grow between and into. As the microspheres slowly dissolve they are replaced by new tissue. As a first in man feasibility study, the aim of this clinical trial is to demonstrate that the microspheres are safe when implanted into perianal fistulas in humans.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1776
Date of REC Opinion
14 Oct 2016
REC opinion
Favourable Opinion