Characterizing In Vivo Oral Lesion Impedances

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 probe's tip, to minimize cable lengths and maximize the signal-to-noise ratio. A pressure sensor is embedded within the probe to reduce variability in the amount of pressure used when the probe is applied to soft tissue. The bioimpedance-sensing probe is designed to the following specifications in order to accurately assess oral lesions:

• measurement precision ~85 dB,
• accuracy >99%,
• bandwidth extending to 1 MHz, and
• multi-frequency sample rate of >10 impedance spectra per second.

Similar to other EII systems the team has developed and deployed in vivo, the system complies with International Electrotechnical Commission (IEC) requirements for safety and essential performance of medical electrical equipment (IEC 60601-1).

There are no known probes cleared by the FDA for this application.

The study is not being conducted in order to evaluate the EII probe's safety or effectiveness in human subjects, nor to test the device for marketing or promotion.

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.

10.1.2 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.

10.2.3 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.