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Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Primary Purpose

Colon Polyps, Colonic Dysplasia, Anal Dysplasia

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Proflavine Hemisulfate

About this trial

This is an interventional screening trial for Colon Polyps focused on measuring colon polyps, colonic dysplasia, anal dysplasia, microendoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mount Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proflavine Hemisulfate

Arm Description

Outcomes

Primary Outcome Measures

to determine whether tissue in nepoplastic or non-neoplastic

Secondary Outcome Measures

Full Information

NCT ID

NCT01384240

First Posted

June 27, 2011

Last Updated

January 8, 2016

Sponsor

Anandasabapathy, Sharmila, M.D.

1. Study Identification

Unique Protocol Identification Number

NCT01384240

Brief Title

Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Official Title

Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Why Stopped

Study is closed as the PI transferred to another institution.

Study Start Date

April 2010 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anandasabapathy, Sharmila, M.D.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Polyps, Colonic Dysplasia, Anal Dysplasia

Keywords

colon polyps, colonic dysplasia, anal dysplasia, microendoscopy

7. Study Design

Primary Purpose

Screening

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

183 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Proflavine Hemisulfate

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Proflavine Hemisulfate

Other Intervention Name(s)

Proflavine

Intervention Description

3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)

Primary Outcome Measure Information:

Title

to determine whether tissue in nepoplastic or non-neoplastic

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharmila Anandasabapathy, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23780842

Citation

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.

Results Reference

derived

Learn more about this trial

Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

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