Status:
COMPLETED
PRognOstiC valuE of rEd Density in Ulcerative Colitis
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Sapporo Medical University
Imelda GI Clinical Research Center
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
16+ years
Brief Summary
Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission.
Eligibility Criteria
Inclusion
- Confirmed diagnosis of UC for at least 3 months
- Clinical remission with SCCAI \<3 at baseline and stable remission for the last 3 months
- Ability to give informed consent by the patient or legal representative in case of minority.
Exclusion
- Any contraindication for sigmoidoscopy or undergoing biopsies of the rectosigmoid.
- Uncontrolled coagulopathy.
- Any planned change in UC related treatment (both escalation and de-escalation) after the baseline endoscopy
- Planned UC related surgery
- Previous subtotal or total colectomy
- Short bowel, ileostomy or colostomy
- Pregnancy at baseline
- Age younger than 16 years
Key Trial Info
Start Date :
August 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT04408703
Start Date
August 3 2020
End Date
June 1 2022
Last Update
June 27 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Imelda GI clinical research center
Bonheiden, Belgium, 2820
2
UZ Leuven
Leuven, Belgium, 3000