Health TrialsbyHealthPanel

Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorRyan J. Halter

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of prostate cancer requiring RARP.

Ability to understand and the willingness to sign a written informed consent document.

Age ≥ 18 years old

Disqualifiers

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 population

Men with a diagnosis of prostate cancer who require surgery.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • custom device to demonstrate a significant difference in electrical impedance signatures

    Device

    Custom device will be used to measure electrical impedance signatures.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
2023-2025

Secondary outcomes

1

Safety of EI sensing in vivo electrical sensing

Secondary outcome measures will include number of study-related adverse events documented.

Time frame
2023-2025
2

Efficacy of EI sensing in vivo electrical sensing

Tertiary outcome measures will include classification accuracy of EI-based surgical margin assessment

Time frame
2023-2025

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ryan J. Halter

Lead sponsor

Dartmouth-Hitchcock Medical Center

Sponsor institution

Dartmouth College

Collaborator

Source ClinicalTrials.gov
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