Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis: the CONF-UC Study
Not applicable · Testing confocal endomicroscopy · Sites not listed yet · FEDERICA FURFARO
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing confocal endomicroscopy (a procedure). Condition(s) listed: Ulcerative Colitis.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Established diagnosis of UC since at least 12 weeks prior to inclusion
- Age ≥ 18 years
- Any gender/sex
Plus 3 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 26 participants are expected to take part.
- Start date: 2024-10 (planned).
- Main results expected around 2025-10 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis (at 8 weeks and 6 months to treatment initiation)
In the researchers’ words
This study employs a prospective, single-center, interventional design to investigate the prognostic value of confocal endomicroscopy in assessing treatment response in ulcerative colitis (UC) patients receiving small molecules .
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | FEDERICA FURFARO |
| Enrollment | 26 (estimated) |
| Start date | 2024-10 |
| Primary completion (est.) | 2025-10 |
| First posted | 2024-10-03 |
| Last updated | 2024-10-03 |
| Official title | Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis: the CONF-UC Study |
| ClinicalTrials.gov ID | NCT06624579 |
Interventions
- confocal endomicroscopy (Procedure)
The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing.
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Established diagnosis of UC since at least 12 weeks prior to inclusion 2. Age ≥ 18 years 3. Any gender/sex 4. Active disease consistent with indication to start with Small molecules (defined as Mayo endoscopic score (MES) ≥ 1, partial Mayo score ≥ 3 (with at least rectal bleeding score of 1 and bowel movements score of 1) 5. No contraindications to endoscopy or confocal exam 6. Ability to understand and to comply with the study procedure and sign an informed consent form Exclusion Criteria: 1. Subjects with an endoscopic Mayo sub-score at baseline \<2; 2. Pregnancy 3. Subjects with any contraindication to any study procedure (included fluorescein allergy).
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.