Seton-Scaffold Clinical Study
Research type
Research Study
Full title
Seton-Scaffold Clinical Study: A Clinical Investigation of a novel Seton Device to treat fistula-in-ano
IRAS ID
274847
Contact name
Thomas Pinkney
Contact email
Sponsor organisation
Neotherix Ltd
ISRCTN Number
ISRCTN12013338
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
FIA is an abnormal tunnel between the inside of the lower bowel and the skin next to the anus. At least 12,000 people are newly diagnosed with the condition each year in the UK. The FIA condition often starts with an infected gland generating pus, which forms a tunnel to drain away. It is difficult to treat surgically without risking damage to sphincter muscles leading to incontinence. Currently a plastic seton is used to keep the tunnel open, allowing the pus to drain and the tissue to recover from infection. Sometimes FIA tracts can heal after a period of recovery with a seton in place. Other times, the patient continues to develop abscesses and the seton cannot be easily removed and the FIA persists.
There are treatments available to attempt to get rid of the tract altogether, but these have a huge variation in success rate and a high risk of recurrence. This means that FIA can be difficult to manage and may require multiple operations.
We have developed a new device tackle this condition: the Seton-Scaffold. This is a small thin piece of material designed to be placed in the fistula tract. It works in much the same way as a conventional seton to drain the infectious material. What is unique about the Seton-Scaffold is that it is made of a special scaffold material that encourages the body’s cells to migrate and settle into the fistula tract, which is the first step in a process that eventually leads to complete healing. This scaffold material and the thin thread slowly dissolves away over several months, and any left-over material will simply fall off. This application relates to the first in man study of the Seton-Scaffold device, to assess its safety and patient acceptability.
REC name
London - Stanmore Research Ethics Committee
REC reference
20/LO/0896
Date of REC Opinion
29 Jul 2020
REC opinion
Further Information Favourable Opinion