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Enrolling by invitation NCT07365436

Imaging the Colon Using a Colonoscope Compatible Imaging Probe

No phase Interventional Colon Polyps Colonoscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Feasibility of using a CC-OCT probe to image the GI tract.
Who it may be relevant to
Registry conditions: Colon Polyps, Colonoscopy. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study for Imaging the Lower Gastrointestinal Tract Using a Colonoscopy-Compatible OCT Probe

Overview

The goal of this study is to use a colonoscope compatible device capable of taking images of the lower gastrointestinal tract. The main question it aims to answer is: Is the colonoscope compatible optical coherence tomography probe (CC-OCT probe) an effective device to use to take images of the gut? During the participant's standard of care colonoscopy, the CC-OCT probe will be inserted into the colonoscope. The CC-OCT probe will then collect images of the participant's gastrointestinal tract in real time.

Interventions

  • Device Feasibility of using a CC-OCT probe to image the GI tract
    250 participants will be enrolled in this study. All consented participants will receive the same intervention.

Primary outcome measures

  • Ability of the CC-OCT to image the lower GI tract [Time frame: Images are collected during the study procedure and analyzed within one year of collection]

Eligibility criteria

Inclusion criteria

  • 45 years of age or older
  • Capable of giving informed consent
  • Capable of following bowel prep instructions

Exclusion criteria

  • 75 years of age or older
  • Any contraindication to bowel prep or colonoscopy
  • Current diagnosis of any bleeding disorders
  • Currently using drugs that interfere with coagulation (excluding low-dose aspirin)
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07365436 · 2025P001541 · 1R01CA280972-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗