Status:
WITHDRAWN
Oral Stent Device for Radiation Treatments of Oral Cancers
Lead Sponsor:
Indiana University
Conditions:
Tongue Tumor
Tongue Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to examine that ability of the experimental oral stent device to reduce the volume of mandible receiving \>55 Gy by 50%during radiation treatment as assessed duri radiatio...
Eligibility Criteria
Inclusion
- ≥18 year old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Accepted for curative radiation treatment of a tongue tumor, either intact or postoperatively
- Signed consent to study participation
- No history of bleeding disorder
- Platelets within normal limits (150-450 k/cumm)
Exclusion
- History of bleeding disorder
- History of allergy to dental grade material
Key Trial Info
Start Date :
September 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 3 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04041141
Start Date
September 25 2019
End Date
February 3 2021
Last Update
February 9 2021
Active Locations (1)
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1
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202