Clinical trial · Interventional
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
- 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 is closed as the PI transferred to another institution.
Summary
Brief summary (as posted)
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.
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 |
|---|---|---|---|
| Anal Dysplasia | Anal Intraepithelial Neoplasia | ALIAS | 0.90 |
| Colonic Dysplasia | — | UNRESOLVED | — |
| Colon Polyps | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proflavine Hemisulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proflavine Hemisulfate
- interventionNames
- Drug: Proflavine Hemisulfate
Primary outcomes (1)
- measure
- to determine whether tissue in nepoplastic or non-neoplastic
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * surveillance of polyps or disease of the colon * screening colonoscopy * anoscopy for suspected or known anal dysplasia or neoplasia Exclusion Criteria: * unfit for standard colonoscopy or anoscopy * unable to provide informed consent
References
Publications (1)
- DERIVEDChang SS, Shukla R, Polydorides AD, Vila PM, Lee M, Han H, Kedia P, Lewis J, Gonzalez S, Kim MK, Harpaz N, Godbold J, Richards-Kortum R, Anandasabapathy S. High resolution microendoscopy for classification of colorectal polyps. Endoscopy. 2013 Jul;45(7):553-9. doi: 10.1055/s-0032-1326502. Epub 2013 Jun 18. PMID 23780842