Cryobiopsy for Gastrointestinal Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new tool, the cryobiopsy probe, to determine if it can safely and effectively collect tissue samples from the intestines. This tool could enhance understanding and treatment of environmental enteric dysfunction (EED), a condition causing intestinal inflammation and serious health issues in children from areas with poor sanitation. Individuals scheduled for a routine procedure to examine their esophagus, stomach, or upper intestine, who can provide informed consent, might be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could improve children's health in underserved areas.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What prior data suggests that this cryobiopsy probe is safe for obtaining biopsies?
Research has shown that cryobiopsy, a method using a cold tool to take tissue samples, is generally safe for people. One study found that cryobiopsy outperforms the traditional forceps method for obtaining diagnostic samples, making it a dependable tool for doctors.
Regarding safety, another report found that cryobiopsy, even when used with robotic assistance, is safe and practical for various medical procedures. However, some experts indicate that more information is needed to fully understand its safety.
Overall, early findings suggest that cryobiopsy is well-tolerated, but ongoing research is important to confirm these results.12345Why are researchers excited about this trial?
Researchers are excited about the cryobiopsy probe because it offers a new way to collect tissue samples for gastrointestinal disorders. Unlike traditional biopsy techniques that use sharp tools to cut tissue, the cryobiopsy probe freezes and removes tissue samples, which may lead to more intact and higher quality samples. This method might reduce tissue damage and improve diagnostic accuracy, making it a potentially superior option for diagnosing and managing gastrointestinal conditions.
What evidence suggests that the cryobiopsy probe is effective for obtaining biopsies in gastrointestinal disorders?
Research shows that cryobiopsy, a technique using extreme cold to collect tissue samples, is a promising diagnostic tool. Studies have found that cryobiopsy provides more accurate results than traditional methods like needle aspiration. It serves as a safe and effective alternative to the usual forceps biopsy, often used for tissue collection. Cryobiopsy has successfully diagnosed lung and lymph node conditions, capturing detailed tissue information. This trial will test the efficacy of a novel cryobiopsy probe in acquiring tissue samples for studying gastrointestinal disorders like environmental enteric dysfunction (EED), offering a less invasive and more accessible method to obtain important tissue samples.12567
Who Is on the Research Team?
Guillermo Tearney, M.D PhD.
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cryobiopsy and standard forceps biopsy during an elective esophagogastroduodenoscopy
Follow-up
Participants are monitored for safety and effectiveness after biopsy procedures
What Are the Treatments Tested in This Trial?
Interventions
- Cryobiopsy Probe
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Bill and Melinda Gates Foundation
Collaborator