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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Colon Polyps, Colonic Dysplasia, Anal Dysplasia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

to determine whether tissue in nepoplastic or non-neoplastic

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Sharmila Anandasabapathy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

GCO# 09-1040

NCT ID:

NCT01384240

Start Date:

April 2010

Completion Date:

December 2015

Related Keywords:

  • Colon Polyps
  • Colonic Dysplasia
  • Anal Dysplasia
  • colon polyps
  • colonic dysplasia
  • anal dysplasia
  • microendoscopy
  • Neoplasms
  • Colonic Polyps
  • Polyps
  • Hyperplasia

Name

Location

Mount Sinai Medical CenterNew York, New York  10029