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Procedure

OCT-Guided Tissue Sampling for Barrett's Esophagus (IVLCM Trial)

N/A
Recruiting
Led By Gary Tearney, MD., PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing an EGD with biopsy.
Patients must be over the age of 18.
Must not have
Patients with a history of hemostasis disorders.
Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to screen for and collect tissue samples from the esophagus to help predict the risk of developing esophageal cancer.

Who is the study for?
This trial is for adults over 18 who are undergoing an upper GI endoscopy with biopsy. It's not suitable for pregnant women, those with blood clotting disorders, esophageal strictures too narrow for the capsule, or patients on certain blood-thinning medications including NSAIDs.
What is being tested?
The study tests a new device called IVLCM tethered capsule that captures high-resolution images of the esophagus to identify abnormal tissue in Barrett's Esophagus without sedation. Abnormal tissues are then analyzed genomically to predict cancer risk.
What are the potential side effects?
Potential side effects may include discomfort from swallowing the capsule, minor throat irritation after the procedure, and rare risks associated with capturing tissue samples such as bleeding or perforation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for an EGD procedure with a tissue sample collection.
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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of bleeding disorders.
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I am taking blood thinners or NSAIDs currently.
Select...
My esophagus is too narrow for standard capsule tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The number of subjects from which we will be able to collect biopsy samples using IVLCM technique

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IVLCM tethered capsule for biopsiesExperimental Treatment1 Intervention
IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,818 Previous Clinical Trials
8,161,665 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,018 Previous Clinical Trials
13,309,715 Total Patients Enrolled
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
93 Previous Clinical Trials
20,262 Total Patients Enrolled

Media Library

IVLCM tethered capsule (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03830801 — N/A
Barrett's Esophagus Research Study Groups: IVLCM tethered capsule for biopsies
Barrett's Esophagus Clinical Trial 2023: IVLCM tethered capsule Highlights & Side Effects. Trial Name: NCT03830801 — N/A
IVLCM tethered capsule (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03830801 — N/A
~4 spots leftby Dec 2025
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