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

Colon Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01384240
• Other study ID #: GCO# 09-1040
• Status: Terminated
• Phase: Phase 0
• First received: June 27, 2011
• Last updated: January 8, 2016
• Start date: April 2010
• Est. completion date: May 2014

Study information

• Verified date: January 2016
• Source: Anandasabapathy, Sharmila, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 183
• Est. completion date: May 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anal Dysplasia
• Colon Polyps
• Colonic Dysplasia
• Colonic Polyps

Intervention

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

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Anandasabapathy, Sharmila, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to determine whether tissue in nepoplastic or non-neoplastic		1 day	No