A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus
NCT02560623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242
Last updated 2022-11-17
Summary
This study is being done to collect data on the potential use of a sponge on a string device as a non-invasive tool in evaluating patients with Barrett's Esophagus compared to healthy controls.
Conditions
- Barrett Esophagus
Interventions
- PROCEDURE
-
Biopsy
Undergo biopsy
- PROCEDURE
-
Biospecimen Collection
Undergo collection of blood sample
- PROCEDURE
-
Endoscopic Procedure
Undergo endoscopy
- DEVICE
-
Swallowable Sponge Cell Sampling Device
Undergo swallowable sponge cell sampling assessment
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Exact Sciences Corporation
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Prasad G Iyer, M.D. · Mayo Clinic in Rochester
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-10-15
- Primary Completion
- 2021-06-29
- Completion
- 2021-07-08
- FDA Device
- Yes
Countries
- United States
Study Locations
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