A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- Number of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion
研究概览
简要总结
Robotic assisted surgery for benign prostatic hyperplasia (BPH)
详细描述
A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,
- •Subject is able and willing to comply with all the assessments of the study,
- •Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the informed consent form,
- •≥ 45 years of Age,
- •Prostate volume 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year prior to procedure,
- •The subject is indicated for undergoing HoLEP procedure
排除标准
- •Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
- •History of prostate cancer or current/suspected bladder cancer,
- •Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,
- •History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
- •Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,
- •Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated)
- •Previous pelvic irradiation or radical pelvic surgery,
- •Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift,
- •Inability to stop taking anticoagulants for at least 3 days prior to the procedure or antiplatelets and/or coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy is permitted),
- •Any severe illness that would prevent complete study participation or confound study results.
- •Bleeding tendency disorders,
- •Future fertility concerns,
- •Subject has any other disease or condition(s) that would interfere with completion of the study and follow-up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes,
- •Concomitant participation in another interventional study
研究组 & 干预措施
A single-arm open label pilot study
A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.
干预措施: Beacon Platform (Device)
结局指标
主要结局
Number of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion
时间窗: During the procedure.
This endpoint measures the number of participants who successfully complete both the enucleation and morcellation phases of robot-assisted HoLEP (Holmium Laser Enucleation of the Prostate) without the need to convert to a conventional HoLEP or an alternative surgical procedure for treating BPH-related LUTS.Successful completion is defined as completing both phases without using additional devices . This excludes the Roll-in subjects and the use of other devices for hemostasis or dissecting the enucleated tissue during or after the procedure.
Number of subjects with adverse events ( Clavien-Dindo Grade 3a or higher )
时间窗: From procedure date to 30 days
Proportion of subjects with adverse events rated as probably or definitely related to the study procedure (robot-assisted HoLEP or RoLEP) classified as Clavien-Dindo Grade 3a or higher through 30 days post-treatment.
次要结局
- Number of Participants with Capsular Perforation Leading to Procedure Interruption or Conversion(From procedure date to 30 days.)
- Number of Participants with Bladder Perforation Leading to Procedure Interruption or Conversion(From procedure date to 30 days.)
- Operative Time for Procedure Completion(During the procedure.)
- Number of Participants with Ureteric Orifice Damage Requiring Intervention(From procedure date to 30 days.)
- Length of Hospital Stay Post-Procedure(From procedure date to 30 days)
- Length of Catheterization Post-Procedure(From procedure date to 30 days)
- Number of Participants with Repeat Hospitalization for Genitourinary Conditions(From procedure date to 30 days post-procedure.)