Transurethral Periprostatectomy Treatment of Cancerous Prostate Tissue (Peri III Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Lesion Characterization by Location and Thermal Damage
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Treatment with Vanquish System
干预措施: Water Vapor Ablation (Device)
结局指标
主要结局
Lesion Characterization by Location and Thermal Damage
时间窗: Evaluated immediately post procedure.
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.
次要结局
- Adequacy Scale to Measure Visualization During Procedure(From the beginning to the end of the treatment procedure.)
- Safety Measurements(Through 30 days following procedure.)