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NCT Number: NCT06039085

Microendoscopic EI 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location status: Recruiting

Location contact

Einar Sverrisson, MD

SUB_INVESTIGATOR

Lawrence M Dagrosa, MD

CONTACT

[email protected]

603-650-8123

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of prostate cancer requiring RARP.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Age ≥ 18 years old

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.

Treatment and study plan

custom device to demonstrate a significant difference in electrical impedance signatures

Device

Custom device will be used to measure electrical impedance signatures.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Safety of EI sensing in vivo electrical sensing

    Time frame: 2023-2025

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

  2. Efficacy of EI sensing in vivo electrical sensing

    Time frame: 2023-2025

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kathy J Phipps, BA

CONTACT

[email protected]

603 646-5793

Ryan J Halter, PhD

CONTACT

[email protected]

(603) 646-0773

Sponsors and collaborators

Lead sponsor

Ryan J. Halter

Other

Collaborators

  • Dartmouth College

Registry information

Official study title

Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment

Acronym: RARP EI

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 15, 2023
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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