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Optical Frequency Domain Imaging for Assessing Colonic Polyps

Primary Purpose

Colonic Polyps

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MGH Optical Frequency Domain Imaging (OFDI) System
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Colonic Polyps focused on measuring Colonic Polyps, OCT, Imaging, Colon, Polyp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OFDI imaging

Arm Description

OFDI imaging

Outcomes

Primary Outcome Measures

Feasibility and Sensitivity of OFDI Imaging in the Colon
OFDI Images are analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps. A total of 15 subjects were consented, but upon inspection of the colon only 2 participants met the eligibility criteria and participated.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2011
Last Updated
July 25, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01439087
Brief Title
Optical Frequency Domain Imaging for Assessing Colonic Polyps
Official Title
Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing Colonic Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 2009 (Actual)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The colon OFDI catheter will be used in conjunction with a sigmoidoscope. If a sigmoid polyp is identified, the colonoscope will be removed and a sigmoidoscope inserted. The colon OFDI catheter will be advanced through the sigmoidoscope accessory port and positioned adjacent to the colon wall. Imaging will be performed with the OFDI system across the polyp's surface and the base/stalk if pedunculated. The investigators anticipate that on average the investigators will utilize 4 helical scans per polyp. Each of the scans will take less than 30 seconds.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
Keywords
Colonic Polyps, OCT, Imaging, Colon, Polyp

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OFDI imaging
Arm Type
Experimental
Arm Description
OFDI imaging
Intervention Type
Device
Intervention Name(s)
MGH Optical Frequency Domain Imaging (OFDI) System
Intervention Description
Imaging of Colonic Polyps with OFDI system
Primary Outcome Measure Information:
Title
Feasibility and Sensitivity of OFDI Imaging in the Colon
Description
OFDI Images are analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps. A total of 15 subjects were consented, but upon inspection of the colon only 2 participants met the eligibility criteria and participated.
Time Frame
During the OFDI imaging session which should take an average of 5 mintues

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Tearney, MD PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Optical Frequency Domain Imaging for Assessing Colonic Polyps

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