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Pilot Study for Evaluation of Cryobiopsy and Correlation with Standard Forceps Biopsy
This study is not recruiting.
Overview
What we are studying
Environmental enteric dysfunction (EED) is a poorly understood condition characterized by intestinal inflammation and loss of barrier function that is prevalent in regions of the world with inadequate sanitation and hygiene. Progress towards understanding EED and developing effective interventions has been hampered by an inability to evaluate the intestinal mucosa of populations in impoverished regions of the world where this condition is endemic. In order to prevent the deleterious and permanent sequelae of the disease, there is a need for effective diagnosis and intervention to be implemented in EED patients before the age of 2.
Why it is important
Currently, the only means for directly evaluating the intestine is endoscopy with mucosal biopsy. Unfortunately, endoscopy is untenable for the study of EED because of limited resources and the high cost. As a result, there is a clear, unmet need for a less invasive tool that can be used in low-and-middle-income-countries (LMICs) to evaluate the intestine in population with EED. We are doing this research study to find out if a new way to take tissue samples (biopsies) from a patient’s gastrointestinal tract may be useful. Researchers at the Massachusetts General Hospital (MGH) have developed a new device called a cryobiopsy probe. The cryoprobe captures tissue by freezing it to the tip of the probe. This cryobiopsy research procedure will occur just before your scheduled endoscopy.
What we hope to accomplish
The purpose of this study is to explore the feasibility of utilizing a cryobiopsy probe to obtain biopsies in adults. The overall goal is to provide a minimally invasive means of obtaining detailed infantile intestinal tissue information that is needed for the development of effective EED interventions. Obtaining biopsies will play a critical role in gathering the detailed intestinal tissue information.
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Principal Investigator
Who can participate
Healthy Volunteers
Healthy volunteers are eligible for this study
Able to provide informed consent.
Who cannot participate
Those with:
What participants may be asked to do
If you agree to participate in the study, we will introduce through your nose, a thin, flexible tube with a balloon at its end, into your stomach. The balloons will be inflated with either sugar water/saline or heavy liquid metal in order to make it heavy enough to pass into the duodenum, to obtain images and perform cryobiopsies in your duodenum. We will ask you to sip water to facilitate placement of the device and may ask you to sit, lie on your side, stand, or walk to facilitate the correct positioning of the device. Once the tip is inside the duodenum, we will perform cryobiopsies. The cryobiopsy method involves placing a very cold probe in contact with your gastrointestinal tissue for several seconds. Once in contact with the cold probe, the tissue will stick to the probe. When the probe is gently pulled back, a small piece of tissue will be stuck on the probe. A maximum of three cryobiopsies per subject will be collected. Once the procedure is complete, we will deflate the balloon and remove the device from you. In your scheduled endoscopy, the endoscopist will then take 1 standard forceps biopsy from the area adjacent to where cryobiopsy was performed. A maximum of 3 standard forceps biopsies for research purposes only will be taken. The cryobiopsy and standard forceps biopsy samples collected in this study will be brought to the Tearney Research Laboratory for processing. The size and quality of cryobiopsy and standard biopsy samples will be compared. Biopsy collection will be performed at the discretion of the endoscopist.
Project activities may include:
- Office visit
- Endoscopy
Estimated time commitment
5 hours over 1 day
What participants may get
The participants who are undergoing a clinically indicated EGD will receive a check of up to $450 for completing the research study (TNIT successfully introduced, cryobiopsies acquired and standard biopsies acquired). If the catheter is not successfully introduced, the subject will receive $100. If the catheter is introduced but cryobiopsies are not acquired or if the standard biopsy is not taken, the subjects will receive $350. A parking voucher will be provided to all consented subjects. The healthy volunteers who are undergoing elective research EGD will receive up to $1500 for completing the research study (TNIT successfully introduced, cryobiopsies acquired and standard biopsies acquired). If the catheter is not successfully introduced, the subject will receive $100. If catheter is successfully inserted, but cryobiopsies are not taken, they will receive $250. If cryobiopsies are performed, but no EGD is performed, the subject will get $500. If the subject undergoes an EGD with biopsies, they will receive $1500. A parking voucher will be provided to all consented subjects.
Location
Massachusetts General Hosptial
55 Fruit Street Boston, MA 02114
Travel
- Parking reimbursed
- Accessible by public transportation
Travel and Parking Details
Massachusetts General Hospital offers parking for patients and visitors at the Fruit Street, Parkman Street, Yawkey Center and Charles River Plaza garages on our main campus. Due to the high volume of visitors to Mass General every day, we recommend that visitors use public transportation whenever possible. The nearest T stop to the hospital is Charles/MGH, which is on the Red Line.
Additional information
Funding source
- Foundation