Device for detecting leftover prostate cancer tissue during surgery
Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment
This study is testing a special device to see if it can help doctors find leftover prostate cancer tissue during surgery to improve outcomes for men with prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT06039085 on ClinicalTrials.gov |
What this trial studies
This research involves a custom Electrical Impedance Imaging (EII) probe designed to assess whether any prostate cancer tissue remains after prostate removal. Two hundred men diagnosed with prostate cancer will participate, providing data from both in vivo and ex vivo assessments during and after surgery. The study will also monitor any post-surgical complications related to the use of the EII device and evaluate its feasibility for clinical integration. The goal is to improve surgical outcomes by accurately identifying Positive Surgical Margins (PSMs).
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with a clinical diagnosis of prostate cancer requiring robotic-assisted radical prostatectomy (RARP).
Not a fit: Patients with implanted electrical devices, such as pacemakers, or those with impaired decision-making capacity may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce the likelihood of cancer recurrence by ensuring complete removal of prostate cancer tissue.
How similar studies have performed: While the approach of using electrical impedance for surgical margin assessment is innovative, similar studies have shown promise in related fields, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical diagnosis of prostate cancer requiring RARP. 2. Ability to understand and the willingness to sign a written informed consent document. 3. Age ≥ 18 years old Exclusion Criteria: 1. Adults with implanted electrical devices such as pacemakers 2. Prisoners 3. Adults with impaired decision-making capacity 4. Any condition for which, in the opinion of the investigator, contraindicates study participation.
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Ryan J Halter, PhD — Dartmouth-Hitchcock, Manchester
- Study coordinator: Ryan J Halter, PhD
- Email: Ryan.J.Halter@dartmouth.edu
- Phone: (603) 646-0773
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.