Oral LesionNCT05430477
Characterizing In Vivo Oral Lesion Impedances
An observational study of Oral Lesion, run by Ryan J. Halter at 1 site in United States.
Trial 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 secondary study objective is to create a database of in vivo electrical impedance spectra and images of oral lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lesion
- What is being tested?
- Electrical impedance imaging using Non-Significant Risk device (EII probe)
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2022to 20 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential study participants will be identified through Dartmouth-Hitchcock Medical Center (DHMC)'s Head and Neck Tumor Clinic, and will be patients with diagnosed or suspected cancer of the oral cavity, oropharynx, hypopharynx, or larynx who require biopsy or resection for either diagnostic or therapeutic purposes. This study will enroll 250 subjects in two cohorts. Cohort I will consist of 200 patients undergoing oral lesion biopsies. Cohort II will be comprised of 50 patients scheduled for oral cancer resection. A maximum of 5 additional subjects will be initially enrolled in each Cohort to optimize data acquisition.
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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 secondary study objective is to create a database of in vivo electrical impedance spectra and images of oral lesions. This will be achieved by collecting Electrical Impedance sensing data and images from two cohorts of patients: Cohort I will consist of 200 patients undergoing oral lesion biopsies and Cohort II will be comprised of 50 patients scheduled for oral cancer resection. A maximum of 5 additional subjects will be initially enrolled in each Cohort to optimize data acquisition.
Read the 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 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.
- Conditions
- Oral Lesion
- Being tested
- Electrical impedance imaging using Non-Significant Risk device (EII probe)
- Keywords
- electrical impedance tomography (EIT), Oral Lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance imaging using Non-Significant Risk device (EII probe)Device
novel small field-of-view Non-Significant Risk device (EII probe)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Biopsy | Subjects recruited to Cohort I will include patients who are scheduled to undergo oral lesion biopsy as well as patients who are determined to need a biopsy at the time of visual examination, which often occurs in-clinic. Cohort I will consist of 125 oral lesion biopsy patients total. Prior to the start of enrollment in this Cohort, up to 5 additional subjects will be enrolled to optimize the data acquisition process. Receives: Device: Electrical impedance imaging using Non-Significant Risk device (EII probe) | |
| Cohort 2 Resection | Potential study participants will be identified through Dartmouth-Hitchcock Medical Center (DHMC)'s Head and Neck Tumor Clinic, and will be patients with diagnosed or suspected cancer of the oral cavity, oropharynx, hypopharynx, or larynx who require biopsy or resection for either diagnostic or therapeutic purposes. Cohort II will be comprised of 125 patients undergoing oral cavity cancer resections. Initially, up to 5 subjects will be enrolled in addition to the 125 patients in this Cohort in order to optimize the data acquisition process. Receives: Device: Electrical impedance imaging using Non-Significant Risk device (EII probe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Electrical Impedance
This study will use a custom device to measure differences in electrical impedance between normal, benign, premalignant, and malignant oral lesions.
Measured: Participants are on study only the day of the procedure.
Secondary outcomes (1)
Images and Measurements Database Creation
Images and in vivo electrical impedance spectra measurements taken for each participant on the day of the procedure will be used to create a database.
Measured: Participants are on study only the day of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start29 Aug 2022
- Primary completion30 Jun 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryan J. Halter
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR), Dartmouth College
- Responsible party
- Sponsor-investigator, Ryan J. Halter, Dartmouth-Hitchcock Medical Center
- Investigators
- Ryan Halter, PhD, Principal investigator, Trustees of Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430477
- Sponsor's protocol ID
- STUDY02001317
- Other IDs
- R21DE031095-01
- Status last verified
- Aug 2025
- First submitted
- 20 Jun 2022
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing In Vivo Oral Lesion Impedances
- ClinicalTrials.gov ID
- NCT05430477
- Acronym / sponsor ID
- STUDY02001317
- Conditions
- Oral Lesion
- Keywords
- electrical impedance tomography (EIT), Oral Lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Ryan J. HalterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR), Dartmouth College
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 secondary study objective is to create a database of in vivo electrical impedance spectra and images of oral lesions. This will be achieved by collecting Electrical Impedance sensing data and images from two cohorts of patients: Cohort I will consist of 200 patients undergoing oral lesion biopsies and Cohort II will be comprised of 50 patients scheduled for oral cancer resection. A maximum of 5 additional subjects will be initially enrolled in each Cohort to optimize data acquisition.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Biopsy | – | Device: Electrical impedance imaging using Non-Significant Risk device (EII probe)Subjects recruited to Cohort I will include patients who are scheduled to undergo oral lesion biopsy as well as patients who are determined to need a biopsy at the time of visual examination, which often occurs in-clinic. Cohort I will consist of 125 oral lesion biopsy patients total. Prior to the start of enrollment in this Cohort, up to 5 additional subjects will be enrolled to optimize the data acquisition process. |
| Cohort 2 Resection | – | Device: Electrical impedance imaging using Non-Significant Risk device (EII probe)Potential study participants will be identified through Dartmouth-Hitchcock Medical Center (DHMC)'s Head and Neck Tumor Clinic, and will be patients with diagnosed or suspected cancer of the oral cavity, oropharynx, hypopharynx, or larynx who require biopsy or resection for either diagnostic or therapeutic purposes. Cohort II will be comprised of 125 patients undergoing oral cavity cancer resections. Initially, up to 5 subjects will be enrolled in addition to the 125 patients in this Cohort in order to optimize the data acquisition process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential study participants will be identified through Dartmouth-Hitchcock Medical Center (DHMC)'s Head and Neck Tumor Clinic, and will be patients with diagnosed or suspected cancer of the oral cavity, oropharynx, hypopharynx, or larynx who require biopsy or resection for either diagnostic or therapeutic purposes. This study will enroll 250 subjects in two cohorts. Cohort I will consist of 200 patients undergoing oral lesion biopsies. Cohort II will be comprised of 50 patients scheduled for oral cancer resection. A maximum of 5 additional subjects will be initially enrolled in each Cohort to optimize data acquisition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical impedance imaging using Non-Significant Risk device (EII probe)novel small field-of-view Non-Significant Risk device (EII probe) | Device | Cohort 1 Biopsy, Cohort 2 Resection |
Primary outcome
Differences in Electrical Impedance
Time frame: Participants are on study only the day of the procedure.
This study will use a custom device to measure differences in electrical impedance between normal, benign, premalignant, and malignant oral lesions.
1 secondary outcome
Images and Measurements Database Creation
Time frame: Participants are on study only the day of the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Halter, PhD principal investigator
Trustees of Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lesion, run by Ryan J. Halter at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Electrical Impedance (time frame: Participants are on study only the day of the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.