Optical Frequency Domain Imaging for Assessing Colonic Polyps

NCT ID: NCT01439087

Last Updated: 2023-07-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Colonic Polyps

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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OFDI imaging

OFDI imaging

Group Type EXPERIMENTAL

MGH Optical Frequency Domain Imaging (OFDI) System

Intervention Type DEVICE

Imaging of Colonic Polyps with OFDI system

Interventions

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MGH Optical Frequency Domain Imaging (OFDI) System

Imaging of Colonic Polyps with OFDI system

Intervention Type DEVICE

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guillermo Tearney

Professor of Pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillermo Tearney, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2009-P000946

Identifier Type: -

Identifier Source: org_study_id

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