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New treatment option for Barrett's Esophagus
Official title Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
ClinicalTrials.gov ID: NCT02947971
What this study is testing
- What it's testing
- The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE participants to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 85. Healthy volunteers may be eligible.
You may be able to join if
- A previous diagnosis of BE (not an for healthy volunteers)
- Participants 18 years and older with a previous diagnosis of GERD
- Participants 14 years and older with a previous diagnosis of EoE (not an for healthy volunteers)
- Health participants over the age of 18 but less than 85 years of age
- Participants must be able to give informed consent
You likely can't join if
- Participants over 85 years of age
- Participants with the inability to swallow pills and capsules.
- Participants with a strong gag reflex
- Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
- Participants who are pregnant. In case of women of child bearing age, we will ask them if they are pregnant and if unsure; ask them to take a...
See the full eligibility criteria
- A previous diagnosis of BE (not an for healthy volunteers)
- Participants 18 years and older with a previous diagnosis of GERD
- Participants 14 years and older with a previous diagnosis of EoE (not an for healthy volunteers)
- Health participants over the age of 18 but less than 85 years of age
- Participants must be able to give informed consent
- Participants must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
- Participants over 85 years of age
- Participants with the inability to swallow pills and capsules.
- Participants with a strong gag reflex
- Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
- Participants who are pregnant. In case of women of child bearing age, we will ask them if they are pregnant and if unsure; ask them to take a pregnancy test.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.