Clinical trial · Interventional
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low/no enrollment. No subjects were enrolled over the past year.
Summary
Brief summary (as posted)
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| GERD | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescein | Drug | — | UNRESOLVED |
| Proflavine hemisulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fluorescein
- description
- Confocal imaging using contrast agent fluorescein
- interventionNames
- Drug: Proflavine hemisulfate
- type
- EXPERIMENTAL
- label
- Proflavine hemisulfate
- description
- confocal imaging using contrast agent proflavine
- interventionNames
- Drug: Fluorescein
Primary outcomes (1)
- measure
- to determine whether tissue is neoplastic or non-neoplastic
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patient 18 years or older * colonoscopy for screening or surveillance of polyps or disease of colon * anoscopy because of suspected or known anal dysplasia or neoplasia Exclusion Criteria: * patient unable to provide informed consent * patient found unfit for standard colonoscopy or anoscopy with biopsies
References
Publications (0)
Data not yet available