N/A N=2 Device Feasibility

Optical Frequency Domain Imaging for Assessing Colonic Polyps

Colonic Polyps

Bottom Line

View on ClinicalTrials.gov: NCT01439087 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcome: Primary: Feasibility and Sensitivity of OFDI Imaging in the Colon — 2; 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MGH Optical Frequency Domain Imaging (OFDI) System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility and Sensitivity of OFDI Imaging in the Colon	2; 1	—

Summary

The goal of this research is to conduct a pilot clinical study to image colonic polyps with the intent to evaluate the potential use of Optical Frequency Domain Imaging (OFDI) to identify the extent of invasion (if present), differentiate between hyperplastic polyps and adenomas, and identify serrated polyps.

Eligibility Criteria

Inclusion Criteria

Patients undergoing a screening colonoscopy
Patients must be over the age of 18
Patient must be able to give informed consent

Exclusion Criteria

Patients with hemostasis disorders
Patients taking any anti-coagulants such as Coumadin or Plavix,

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01439087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.