Study Stopped
Study is closed as the PI transferred to another institution.
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
1 other identifier
interventional
183
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Apr 2010
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJanuary 12, 2016
January 1, 2016
3.3 years
June 27, 2011
January 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to determine whether tissue in nepoplastic or non-neoplastic
1 day
Study Arms (1)
Proflavine Hemisulfate
EXPERIMENTALInterventions
3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)
Eligibility Criteria
You may qualify if:
- surveillance of polyps or disease of the colon
- screening colonoscopy
- anoscopy for suspected or known anal dysplasia or neoplasia
You may not qualify if:
- unfit for standard colonoscopy or anoscopy
- unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Medical Center
New York, New York, 10029, United States
Related Publications (1)
Chang 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: 23780842DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharmila Anandasabapathy, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2011
First Posted
June 29, 2011
Study Start
April 1, 2010
Primary Completion
July 1, 2013
Study Completion
May 1, 2014
Last Updated
January 12, 2016
Record last verified: 2016-01