Status:
COMPLETED
Characterizing In Vivo Oral Lesion Impedances
Lead Sponsor:
Ryan J. Halter
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Oral Lesion
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to demonstrate a significant difference in electrical impedance between normal, benign, premalignant, and malignant oral lesions using a custom device. The secon...
Detailed Description
For this study, a novel small field-of-view EII probe will be used for recording impedances from oral lesions. The device is comprised of gold-plated electrodes with analog electronics located in the ...
Eligibility Criteria
Inclusion
- Cohort 1 10.1.1 Inclusion Criteria
- Suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring biopsy.
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years old.
- If a female of child bearing potential, then a negative pregnancy evaluation per standard of care.
- 1.2 Exclusion Criteria
- Adults having had a previous oral biopsy within the last 30 days
- Adults with implanted electrical devices such as pacemakers
- Prisoners
- Adults with impaired decision-making capacity
- Has any condition for which, in the opinion of the investigator, contraindicates study participation.
- Cohort 2 10.2.2 Inclusion Criteria
- Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection.
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years old
- If a female of child bearing potential, then a negative pregnancy evaluation per standard of care.
- 2.3 Exclusion Criteria
- Adults with implanted electrical devices such as pacemakers
- Prisoners
- Adults with impaired decision-making capacity
- Any condition for which, in the opinion of the investigator, contraindicates study participation.
Exclusion
Key Trial Info
Start Date :
August 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 20 2025
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05430477
Start Date
August 29 2022
End Date
August 20 2025
Last Update
September 22 2025
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756