Evaluating a 3D Printed Oral Stent Device with Suction for Oral Cancer RT
M
Mark Langer, MD
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
6 participants needed
2 Locations
Overview
What is the purpose of this study?
A foam bite is the standard device used to hold the tongue in place during radiation treatment of cancers of the tongue. There is no device currently available to fix the tongue in place and remove oral secretions (i.e. saliva) through suction tubing attached to the stent.
We wish to see if an experimental 3D printed oral stent device will potentially improve treatment for tongue cancer patients compared to the standard bite block by decreasing motion and increase stability.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Description
What will happen during the study?
- All potential participants will have undergone oncologic surgery. Within 90 days from surgery, subjects will be screened for eligibility, consented, and enrolled. Their medical history will be reviewed.
- Participants will come to the clinic for their standard of care CT scan planning sessions.
- Each visit will consist of the standard planning CT scan, performed twice: once with the bite block and once with the experimental oral stent. Visits will last approximately 20 minutes.
- Participation will last approximately 4 months.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Tongue tumor, Oral radiation
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Willing and able to provide informed consent
- Accepted for curative radiation treatment of a tongue tumor after operation
Exclusion Criteria:
- History of allergy to dental grade material
- Over 90 days out from surgery before enrollment
Updated on
20 May 2024.
Study ID: 2011794097, RAON-IIR-IUSCC-0745
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