Trials / Completed
CompletedNCT04972097
Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue
Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Angiodynamics, Inc. · Industry
- Sex
- Male
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Irreversible Electroporation | IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes. |
Timeline
- Start date
- 2022-03-29
- Primary completion
- 2024-08-14
- Completion
- 2024-08-14
- First posted
- 2021-07-22
- Last updated
- 2025-02-12
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04972097. Inclusion in this directory is not an endorsement.