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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights
IVLCM Trial 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.Check my eligibility
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.See study design
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.
IVLCM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for an EGD procedure with a tissue sample collection.
Select...
I am over 18 years old.
IVLCM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of subjects from which we will be able to collect biopsy samples using IVLCM technique
IVLCM 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
2,701 Previous Clinical Trials
7,506,846 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,451 Total Patients Enrolled
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
89 Previous Clinical Trials
19,721 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.I have a history of bleeding disorders.I am taking blood thinners or NSAIDs currently.My esophagus is too narrow for standard capsule tests.I am scheduled for an EGD procedure with a tissue sample collection.I am over 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: IVLCM tethered capsule for biopsies
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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