Clinical trial · Observational
Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment
Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment
NCT06039085CI-TRIAL-00107516RARP EIrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| custom device to demonstrate a significant difference in electrical impedance signatures | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Electrical impedance difference between positive and negative surgical margins
- timeFrame
- 2023-2025
- description
- 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 (2)
- measure
- Safety of EI sensing in vivo electrical sensing
- timeFrame
- 2023-2025
- description
- Secondary outcome measures will include number of study-related adverse events documented.
- measure
- Efficacy of EI sensing in vivo electrical sensing
- timeFrame
- 2023-2025
- description
- Tertiary outcome measures will include classification accuracy of EI-based surgical margin assessment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.