NCT04565704

Brief Summary

To develop novel optical imaging technologies for use as a non-destructive and minimally invasive tool for detection and diagnosis of various diseases that affect the gastrointestinal system.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress79%
Mar 2016Dec 2028

Study Start

First participant enrolled

March 25, 2016

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

11.8 years

First QC Date

August 11, 2020

Last Update Submit

October 20, 2025

Conditions

Gastrointestinal DiseaseGastrointestinal Dysfunction

Keywords

OCTOptical Coherence TomographyBiopsyGI diseaseEndoscopy screeningEndoscopic Screening

Outcome Measures

Primary Outcomes (1)

  • Device Feasibility based on image quality and presence of microscopic features

    The feasibility will be determined by at least one of the following parameters: 1) assessing image adequacy (resolution, contrast, etc.) qualitatively, 2) confirming that microscopic features observed in the images are also seen by correlative histopathology, 3) ability to develop preliminary criteria or algorithms based on image-histopathology matches.

    Imaging data is collected during the procedure, and analyzed within 1 year of collection.

Study Arms (1)

Development of novel optical imaging technologies

EXPERIMENTAL

Consented participants will allow their endoscopist to collect 3 additional biopsies from the participants. These biopsies will be used to develop our imaging techniques at our lab. We will use the standard of care histology images from the endoscopy procedure as a control comparison.

Device: Biopsy imaged by Optical imaging device.

Interventions

Biopsy imaged by Optical imaging device.DEVICE
Development of novel optical imaging technologies

Eligibility Criteria

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

You may qualify if:

  • Scheduled for an elective esophagoduodenoscopy and/or colonoscopy

You may not qualify if:

  • According to standard of care at MGH endoscopy department.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Guillermo Tearney, M.D, PhD.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator - MD, PhD, FACC, FCAP, FNAI

Study Record Dates

First Submitted

August 11, 2020

First Posted

September 25, 2020

Study Start

March 25, 2016

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)