NCT01979458

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 24, 2017

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

November 4, 2013

Last Update Submit

March 22, 2017

Conditions

Colonic Polyps

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Image Contrast

    Comparison of image contrast obtained using standard colonoscopy and PSE.

    Immediate

Study Arms (1)

PSE

EXPERIMENTAL

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

Device: PSE

Interventions

PSEDEVICE
Also known as: photometric stereo endoscopy
PSE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 8, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 24, 2017

Record last verified: 2014-09

Locations

US(1)