Clinical trial · Interventional
The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal Therapy
The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal therapy-a Phase I Study
- 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 trial is studying the effects and safety in treating patients with local prostate cancer with a new IRE device called Composite Steep-pulse Treatment Apparatus. This new device could cause cell irreversible electroporation, which leading necrosis of tumor cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and histopathological analysis of prostate speciem will be evaluated in each study patients.
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 |
|---|---|---|---|
| steep pulse device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Steep Pulse Device
- description
- Applying the steep pulse to treat the patients with Prostate cancer
- interventionNames
- Device: steep pulse device
Primary outcomes (2)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure
- timeFrame
- 1 Year
- description
- To determine if the IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma.
- measure
- Efficacy (persentage of unablated tissue un the ablation zone)
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Prostate MRI can identify the suspect region(pi-RADS≥4 ) ,and no evidence of lymphatic metastasis 2. Patients must have confirmed prostate cancer by prostate biopsy 3. There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI 4. No prostatic calculus or prostatic calculus≤5mm 5. No contraindication on total intravenous anesthesia 6. Not take any anticoagulants before or discontinue anticoagulant therapy at least 7 days 7. Age ≥ 30 - ≤ 75 years 8. Life expectancy of greater than 10 years 9. Patients scheduled for radical prostatectomy. 10. Sexually potent Exclusion Criteria: 1. Patients have previously undergone radical prostatectomy. 2. Patients have previously undergone hormonal therapy or radiotherapy. 3. Patients underwent other surgery before less than 3 months 4. Clinically significant cardiovascular disease 5. Patients with other malignant tumor or patients with hiv. 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 7. Patients with poor health condition 8. Simultaneous participation in another clinical trial
References
Publications (0)
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