Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis: the CONF-UC Study

NCT06624579 | Not Yet Recruiting DMC

• 1 other identifier: IRCCS SAN RAFAEL HOSPITAL
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis

  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.

  at 8 weeks and 6 months to treatment initiation

Study Arms (1)

confocal endomicroscopy

OTHER

Endoscopic confocal microscopy with fluorescein injection is a medical imaging technique that combines endoscopy with confocal microscopy and the injection of fluorescein, a fluorescent dye. During colonoscopy or rettosigmoidoscopy, confocal microscopy is used, which provides high-resolution images of tissues at a cellular level. This technology uses a thin probe with a laser light source and a detection system to analyze specific layers of tissue. During the examination, a solution of fluorescein is injected into the patient's peripheric vein. Fluorescein is a dye that binds to cellular structures, making them fluorescent when exposed to laser light. This allows to visualize cellular details in real-time during endoscopy

Procedure: confocal endomicroscopy

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.

confocal endomicroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Any gender/sex
• 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)
• No contraindications to endoscopy or confocal exam
• Ability to understand and to comply with the study procedure and sign an informed consent form

You may not qualify if:

• Subjects with an endoscopic Mayo sub-score at baseline \<2;
• Pregnancy
• Subjects with any contraindication to any study procedure (included fluorescein allergy).

Sponsors & Collaborators

• FEDERICA FURFARO: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

FEDERICA FURFARO GASTROENTEROLOGIST

CONTACT

0039+0226432069; furfaro.federica@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, MD

Model Details: 26 adult subjects with moderate-to-severe active (defined as having patient-reported outcomes, PRO \> 2), left-sided or extensive UC, requiring small molecules therapy according to the standards of care (ECCO guidelines) and performing routine investigations with Colonoscopy before starting appropriate therapy, according to the current standard of care indications and ECCO guidelines.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: October 3, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 3, 2024

Record last verified: 2024-10