About this trial
Last updated 2 months ago
Study ID
Alofisel-5007
Status
Active, not recruiting
Type
Observational
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 4 years ago
What is this trial about?
In this study, participants with complex fistulizing conditions will be treated with
surgical interventions according to their clinic's standard practice.
The aim of the study is to generate real-world evidence on standard of care for surgical
interventions and related outcomes when treating complex fistulizing conditions.
The study sponsor will not be involved in how participants are treated but will provide
instructions on how the clinics will record what happens during the study.
What are the participation requirements?
Inclusion Criteria
Both men and women can take part.
Must be adults at least 18 years old.
People with one of the following conditions:
o Complex perianal fistula in Crohn’s disease (CPF-CD).
o Crohn’s disease with rectovaginal fistulas (CD-RVF).
o Complex cryptoglandular fistulas (CCF).
Additional entry criteria will be discussed with the study doctor.
For more information, view the full study details:
NCT04940611