Prostate CancerRARP EINCT06039085
Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment
An observational study of Prostate Cancer, run by Ryan J. Halter at 1 site in United States.
Trial summary
This research will study a custom device developed to detect if any prostate cancer tissue is left behind when the prostate is removed. This device is called an Electrical Impedance Imaging (EII) probe. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- custom device to demonstrate a significant difference in electrical impedance signatures
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with a diagnosis of prostate cancer who require surgery.
Who may be able to join
- Clinical diagnosis of prostate cancer requiring RARP.
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years old
Who cannot join
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Lawrence M Dagrosa, MD, 603-650-8123, Lawrence.M.Dagrosa@hitchcock.org
Einar Sverrisson, MD
About this study
Official title: Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment
This research will study a custom device developed to detect if any prostate cancer tissue is left behind when the prostate is removed. This device is called an Electrical Impedance Imaging (EII) probe.
Read the detailed description
Two hundred men will be recruited to participate in this trial. Consent will be obtained from all participating men prior to surgery.
The trial will consist of recording EII data from:
- In vivo pelvic floor and peri-prostatic tissues remaining after the prostate has been resected
- Resected ex vivo prostate following extraction from the abdomen (in the OR)
- Resected ex vivo prostate when transferred to Pathology, post-RARP
The study team will also track post-surgical complications due to the study's technology (e.g., infection) and additional time required to deploy the study technology used to assess feasibility of clinical integration of the EII device. Post-RARP pathological assessment of margin tissues will be used to train and evaluate the study's classification schemes for identifying Positive Surgical Margin (PSMs).
- Conditions
- Prostate Cancer
- Being tested
- custom device to demonstrate a significant difference in electrical impedance signatures
- Keywords
- Impedance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom device to demonstrate a significant difference in electrical impedance signaturesDevice
Custom device will be used to measure electrical impedance signatures.
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical impedance difference between positive and negative surgical margins
Outcome measures will include how significantly different electrical impedance signatures are between impedance recordings of positive and negative surgical margins as acquired during prostate surgery.
Measured: 2023-2025
Secondary outcomes (2)
Safety of EI sensing in vivo electrical sensing
Secondary outcome measures will include number of study-related adverse events documented.
Measured: 2023-2025
Efficacy of EI sensing in vivo electrical sensing
Tertiary outcome measures will include classification accuracy of EI-based surgical margin assessment
Measured: 2023-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start3 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ryan J. Halter
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Sponsor-investigator, Ryan J. Halter, Dartmouth-Hitchcock Medical Center
- Investigators
- Ryan J Halter, PhD, Principal investigator, Dartmouth-Hitchcock, Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039085
- Sponsor's protocol ID
- STUDY02001660
- Acronym
- RARP EI
- Status last verified
- Apr 2026
- First submitted
- 31 Aug 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment
- ClinicalTrials.gov ID
- NCT06039085
- Acronym / sponsor ID
- RARP EI / STUDY02001660
- Conditions
- Prostate Cancer
- Keywords
- Impedance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ryan J. HalterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Sep 2023 (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.
This research will study a custom device developed to detect if any prostate cancer tissue is left behind when the prostate is removed. This device is called an Electrical Impedance Imaging (EII) probe.
Detailed description
Two hundred men will be recruited to participate in this trial. Consent will be obtained from all participating men prior to surgery.
The trial will consist of recording EII data from:
- In vivo pelvic floor and peri-prostatic tissues remaining after the prostate has been resected
- Resected ex vivo prostate following extraction from the abdomen (in the OR)
- Resected ex vivo prostate when transferred to Pathology, post-RARP
The study team will also track post-surgical complications due to the study's technology (e.g., infection) and additional time required to deploy the study technology used to assess feasibility of clinical integration of the EII device. Post-RARP pathological assessment of margin tissues will be used to train and evaluate the study's classification schemes for identifying Positive Surgical Margin (PSMs).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with a diagnosis of prostate cancer who require surgery.
Key inclusion criteria (3 listed)
- Clinical diagnosis of prostate cancer requiring RARP.
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years old
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| custom device to demonstrate a significant difference in electrical impedance signaturesCustom device will be used to measure electrical impedance signatures. | Device | – |
Primary outcome
Electrical impedance difference between positive and negative surgical margins
Time frame: 2023-2025
Outcome measures will include how significantly different electrical impedance signatures are between impedance recordings of positive and negative surgical margins as acquired during prostate surgery.
2 secondary outcomes
Safety of EI sensing in vivo electrical sensing
Time frame: 2023-2025
Efficacy of EI sensing in vivo electrical sensing
Time frame: 2023-2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Ryan J Halter, PhD principal investigator
Dartmouth-Hitchcock, Manchester
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 Prostate Cancer, 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?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan J Halter, PhD ((603) 646-0773, Ryan.J.Halter@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical impedance difference between positive and negative surgical margins (time frame: 2023-2025). 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 7 Apr 2026.