Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon

NCT ID: NCT01979458

Last Updated: 2017-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-07-31

Brief Summary

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The goal of this research is to assess photometric stereo endoscopy (PSE) as an endoscopic imaging technique. Specifically, topographical surface contrast reconstructed from the PSE data will be compared to conventional imaging contrast to assess if PSE provides enhanced contrast of abnormal tissue.

Detailed Description

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Conditions

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Colonic Polyps

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PSE

Patients whose distal colon is imaged using the PSE device. This is a pilot trial of 30 patients.

Group Type EXPERIMENTAL

PSE

Intervention Type DEVICE

Interventions

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PSE

Intervention Type DEVICE

Other Intervention Names

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photometric stereo endoscopy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with bleeding/hemostasis disorders
* Patients that are pregnant
* Patients taking any anti-coagulants that would preclude them from undergoing a standard of care colonoscopy, such as Coumadin and Plavix, at the time of the study
* Patients with known colitis or active bleeding will be excluded
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 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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Norman Nishioka, MD

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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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2013P001115

Identifier Type: -

Identifier Source: org_study_id

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