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

This study has been terminated.
(Study is closed as the PI transferred to another institution.)
Sponsor:
Information provided by (Responsible Party):
Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier:
NCT01384240
First received: June 27, 2011
Last updated: June 24, 2014
Last verified: June 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 ]

Enrollment: 183
Study Start Date: April 2010
Study Completion Date: May 2014
Primary Completion Date: July 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384240

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
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: June 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 July 20, 2014