NCT07567027招募中不适用
Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR) Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the feasibility, safety, and potential protective benefit of Barrigel, a hyaluronic acid-based rectal spacer, in patients undergoing prostate cryoablation for localized or recurrent prostate cancer. The primary aim is to assess Barrigel thermal stability during cryoablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 40-95 years.
- •Biopsy-confirmed localized prostate cancer (Grade Group ≥ 2). Salvage cryoablation cases may be included.
- •Unifocal disease visible on multiparametric MRI (mpMRI) and amenable to focal or whole gland cryoablation.
- •Prostate-specific antigen (PSA) < 20 ng/ml.
- •No metastatic disease on Prostate-Specific Membrane Antigen (PSMA) PET/CT, when recommended per National Comprehensive Cancer Network (NCCN) guidelines.
- •Eligible for and consenting to transperineal cryoablation under anesthesia.
- •Willingness to comply with post-procedure follow-up, including PSA testing and imaging.
- •Cryoablation which requires treatment of the posterior prostate as per clinician judgement.
排除标准
- •Evidence of metastatic disease.
- •Prior radiation therapy to the area of the prostate.
- •Active rectal or urinary tract infection.
- •Known allergy to hyaluronic acid products or contrast agents.
- •Inability to tolerate MRI.
- •Inability or unwillingness to comply with study follow-up.
研究组 & 干预措施
Barrigel Placement
Experimental
Each subject will undergo transperineal ultrasound-guided Barrigel placement prior to their image-guided prostate cryoablation in the same procedure session.
干预措施: Barrigel Injectable Gel (Device)
Barrigel Placement
Experimental
Each subject will undergo transperineal ultrasound-guided Barrigel placement prior to their image-guided prostate cryoablation in the same procedure session.
干预措施: Cryoablation (Procedure)
研究者
研究点 (1)
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