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

This study is currently recruiting participants.
Verified March 2014 by Anandasabapathy, Sharmila, M.D.
Sponsor:
Information provided by (Responsible Party):
Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier:
NCT01384240
First received: June 27, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Colon Polyps
Colonic Dysplasia
Anal Dysplasia
Drug: Proflavine Hemisulfate
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Resource links provided by NLM:


Further study details as provided by Anandasabapathy, Sharmila, M.D.:

Primary Outcome Measures:
  • to determine whether tissue in nepoplastic or non-neoplastic [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Proflavine Hemisulfate
    3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384240

Contacts
Contact: Josie Mitcham 212-241-6293 josephine.mitcham@mountsinai.org
Contact: Sharmila Anandasabapathy, MD 212-241-7535 sharmila.anandasabapathy@mountsinai.org

Locations
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Josie Mitcham    212-241-6293    josephine.mitcham@mountsinai.org   
Contact: sharmila anandasabapathy, MD    212-241-7535    sharmila.anandasabapathy@mountsinai.org   
Principal Investigator: Sharmila Anandasabapathy, MD         
Sponsors and Collaborators
Anandasabapathy, Sharmila, M.D.
Investigators
Principal Investigator: Sharmila Anandasabapathy, MD Mount Sinai School of Medicine
  More Information

No publications provided by Anandasabapathy, Sharmila, M.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier: NCT01384240     History of Changes
Other Study ID Numbers: GCO# 09-1040
Study First Received: June 27, 2011
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Anandasabapathy, Sharmila, M.D.:
colon polyps
colonic dysplasia
anal dysplasia
microendoscopy

Additional relevant MeSH terms:
Neoplasms
Colonic Polyps
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical
Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014