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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| custom device to demonstrate a significant difference in electrical impedance signatures | Device | Custom device will be used to measure electrical impedance signatures. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of EI sensing in vivo electrical sensing | Secondary outcome measures will include number of study-related adverse events documented. | 2023-2025 |
| Efficacy of EI sensing in vivo electrical sensing |
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Inclusion Criteria:
Exclusion Criteria:
Participants will be biologically male due to this study's focus on prostate cancer
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Men with a diagnosis of prostate cancer who require surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Ryan J Halter, PhD | Dartmouth-Hitchcock, Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Tertiary outcome measures will include classification accuracy of EI-based surgical margin assessment
| 2023-2025 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |