Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment

NCT06039085 | Recruiting DMC

• 1 other identifier: STUDY02001660
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Impedance

Outcome Measures

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.

  2023-2025

Secondary Outcomes (2)

• Safety of EI sensing in vivo electrical sensing

  2023-2025

• Efficacy of EI sensing in vivo electrical sensing

  2023-2025

Interventions

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

Custom device will be used to measure electrical impedance signatures.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants will be biologically male due to this study's focus on prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with a diagnosis of prostate cancer who require surgery.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ryan J. Halter: lead
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ryan J Halter, PhD

  Dartmouth-Hitchcock, Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan J Halter, PhD

CONTACT

(603) 646-0773; Ryan.J.Halter@dartmouth.edu

Kathy J Phipps, BA

CONTACT

603 646-5793; kathy.j.phipps@dartmouth.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator and Regulatory Sponsor

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 15, 2023
• Study Start: November 3, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)