Clinical trial · Interventional
Transurethral Periprostatectomy Treatment of Cancerous Prostate Tissue
Transurethral Periprostatectomy Treatment of Cancerous Prostate Tissue (Peri III 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 goal of this clinical trial is to determine if the Vanquish System can safely and effectively treat cancerous tissue in the prostate. Researchers will also determine the best treatment dose, monitor safety during and immediately after the procedure, and examine prostate tissue after surgical removal to confirm how well the treatment destroyed targeted tissue. Patients enrolled have been diagnosed with prostate cancer and will undergo treatment with the Vanquish System before their scheduled radical prostatectomy.
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 |
|---|---|---|---|
| Water Vapor Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment with Vanquish System
- interventionNames
- Device: Water Vapor Ablation
Primary outcomes (1)
- measure
- Lesion Characterization by Location and Thermal Damage
- timeFrame
- Evaluated immediately post procedure.
- description
- The primary efficacy endpoint is a lesion characterization from the Peri III Study vapor treatment as evaluated by TTC stain. Immediately following treatment and surgical extirpation, the prostate was examined for any external thermal injury followed by whole mount sectioning and staining using tetrazolium chloride (TTC). The whole mount sections were photographed before and after TTC staining. The sections and photographs were examined for ablation within all anatomic regions of the prostate and the ability to ablate to different regions and zones of the prostate.
Secondary outcomes (2)
- measure
- Adequacy Scale to Measure Visualization During Procedure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is 40 years or older * Subjects is diagnosed with clinically localized prostate cancer (Stage I (T1c) or Stage II (T2a, T2b, T2c tumor) prostate cancer) AND scheduled for a radical prostatectomy or cystoprostatectomy due to the presence of prostate cancer * Subject has a positive biopsy for prostate cancer with Gleason score of 8 (4+4) and below * Subject who provides written consent to participate in the study Exclusion Criteria: * Subject with prostate biopsy performed within 42 days from date of prostatectomy. * Subject has a known allergy to nickel. * Subject who had previous rectal surgery (other than hemorrhoidectomy) * Subject with known history of rectal disease. * Subject currently participating in other premarket investigational studies. * Subject who had a previous TURP or prostatectomy.
References
Publications (0)
Data not yet available