Clinical trial · Interventional
Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to equipment breakage and lack of funding.
Summary
Brief summary (as posted)
The overall aim of this research project is to evaluate the imaging performance of a confocal endomicroscope. Fluorescein, an FDA-approved topical fluorescent dye, will be used to provide topical mucosal contrast. The purpose of this instrument is to provide real-time endoscopic "histology" to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group. This endomicroscope probe will be used during colonoscopies in subjects with colonic dysplasia, known colonic adenomatous polyps scheduled for endoscopic resection, or suspected dysplasia in subjects with Inflammatory Bowel Disease (IBD).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
| Colonic Dysplasia | — | UNRESOLVED | — |
| Irritable Bowel Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| confocal endomicroscope | Device | — | UNRESOLVED |
| Fluorescein | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Subjects with abnormal colon tissue
- description
- The study subjects will be high-risk for colonic adenomas (i.e. strong family history of adenomas/adenocarcinoma or personal history of adenomas/adenocarcinoma), known adenoma scheduled for endoscopic resection, or in subjects with suspected dysplasia in inflammatory bowel disease (IBD). Fluorescein will be sprayed on the area of interest to provide imaging contrast for the images taken with the confocal endomicroscope.
- interventionNames
- Device: confocal endomicroscope
- Drug: Fluorescein
Primary outcomes (1)
- measure
- Depth-imaging capability of the confocal endomicroscope using an imaging contrast agent, fluorescein
- timeFrame
- five minutes
- description
- The test product efficacy will be assessed by evaluating the fluorescence intensities measured from suspicious regions of colonic mucosa where the agent is administered compared to adjacent normal mucosa.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: Subject meets at least one of the following criteria: * At increased risk for colorectal cancer and colonic polyps * Known colonic adenomas scheduled for colonic polyp resection * Scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia. Exclusion Criteria: Subject meets all of the following criteria: * Subject is scheduled for outpatient colonoscopy in the Medical Procedures Unit at University of Michigan Health System. * Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) Standard practice guidelines for safely proceeding with the procedure will be sufficient for our study. * Age 18 to 100 years * Willing and able to sign informed consent
References
Publications (0)
Data not yet available