Cytosponge™ Feasibility Study in Tanzania
NCT04090554 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2021-08-25
Summary
A Tanzanian pilot study to test the feasibility of using the Cytosponge™ device - a less-invasive endoscopy alternative - for research on esophageal squamous cell carcinoma in African settings.
Conditions
- Esophageal Diseases
- Esophagus SCC
Interventions
- DEVICE
-
Cytosponge™
The device consists of a spherical mesh enclosed in a gelatine capsule and attached to a string. The capsule is swallowed and allowed to reach the stomach . In the stomach the capsule is left for up to 5 minutes where it dissolves allowing the sponge to expand to its full size. It is then withdrawn using the suture, and as it does so collects cells from the lining of the oesophagus.
Sponsors & Collaborators
-
Kilimanjaro Clinical Research Institute
collaborator OTHER - collaborator OTHER
-
International Agency for Research on Cancer
lead OTHER
Principal Investigators
-
Valerie A McCormack, PhD · International Agency for Research on Cancer
-
Venance Maro, MD · Kilimanjaro Clinical Research Institute
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-09-24
- Primary Completion
- 2019-12-20
- Completion
- 2020-12-30
Countries
- Tanzania
Study Locations
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