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Procedure
Cryobiopsy for Gastrointestinal Disorders
N/A
Waitlist Available
Led By Guillermo Tearney, M.D 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
18 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a cryobiopsy probe can be used to obtain biopsies from adults in a way that is minimally invasive and can be done in low- and middle-income countries.
Who is the study for?
This trial is for adults scheduled for an elective esophagogastroduodenoscopy with biopsy, who can give informed consent. It's not suitable for anyone where standard care would advise against it.
What is being tested?
The study tests a cryobiopsy probe as a less invasive way to obtain intestinal tissue samples in adults, which could help diagnose and treat environmental enteric dysfunction (EED) in resource-limited settings.
What are the potential side effects?
Potential side effects of the cryobiopsy procedure may include discomfort at the biopsy site, bleeding, or infection; however, specific risks will be detailed by the research team.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluation of Cryobiopsy probe
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: Cryobiopsy probe as a tool for biopsyExperimental Treatment1 Intervention
Cryobiopsy probe, administered to study participants.Testing the efficacy of a novel cryobiopsy probe in acquiring tissue samples.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,252 Total Patients Enrolled
Bill and Melinda Gates FoundationOTHER
415 Previous Clinical Trials
22,956,157 Total Patients Enrolled
Guillermo Tearney, M.D PhD.Principal InvestigatorMassachusetts General Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a scope exam of my esophagus, stomach, and upper small intestine with a tissue sample being taken.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Cryobiopsy probe as a tool for biopsy
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.
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