Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Location status: Recruiting
NCT Number: NCT06039085
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.
Interested in participating?
Request Info18 year and older
Male
Observational
Lebanon, New Hampshire, 03756, United States
Location status: Recruiting
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:
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Custom device will be used to measure electrical impedance signatures.
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.
Time frame: 2023-2025
Secondary outcome measures will include number of study-related adverse events documented.
Time frame: 2023-2025
Tertiary outcome measures will include classification accuracy of EI-based surgical margin assessment
Contact information is provided by the study sponsor or research team.
Kathy J Phipps, BA
CONTACT
Ryan J Halter, PhD
CONTACT
Ryan J. Halter
Other
Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment
Acronym: RARP EI
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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