A Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)

Официальное название

A Pilot, Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)

Обзор

This single-arm study aims to evaluate the Beacon Platform, an advancement in urological surgery. The study will assess its intraoperative and postoperative outcomes. The aim of this investigation is to establish safety and performance of the Beacon Platform.

Вмешательства

• Устройство Beacon Platform
  Procedure is performed using the Beacon Platform

Первичные конечные точки

• Successful completion of the enucleation phase of HoLEP with the Beacon Platform [Срок оценки: Perioperative]
• The rate of successful endoscopic access to and visualization of the predefined anatomical landmarks in the urinary tract in a non-inferior fashion compared to standard rigid diagnostic cystoscopy. [Срок оценки: Perioperative]
• Rate of procedure related adverse events (AEs) [Срок оценки: Through study completion, an average of 30 days]

Вторичные конечные точки (6)

• Incidence of bladder perforation or capsular perforation leading to interruption of the procedure or conversion to conventional HoLEP or other alternative procedure [Срок оценки: Perioperative]
• Incidence of ureteric orifice damage leading to stricture, stenting of the ureter, or other sequelae or subsequent intervention [Срок оценки: 30 days]
• Duration of hospital stay following the procedure [Срок оценки: 30 days]
• Duration of catheterization following the procedure [Срок оценки: 30 days]
• Total enucleation time [Срок оценки: Perioperative]
• Incidence of repeat hospitalization for genitourinary conditions within 30 days post procedure [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Male
• 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 30 cc to 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within 180 days prior to procedure,
• The subject is indicated for undergoing HoLEP procedure

Критерии исключения

• Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
• History of prostate cancer or diagnosed 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), bridging anticoagulation therapy is permitted if managed per institutional guidelines and does not increase perioperative bleeding risk
• Any severe illness that would prevent complete study participation or confound study results.
• Bleeding tendency disorders,
• Future fertility concerns,
• Class II obesity or greater (BMI > 35)
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чили · 2 центра

• Clinica Universidad Católica — Santiago
• Hospital Clínico Universidad de Chile — Santiago

Новая Зеландия · 2 центра

• Canterbury Urology Research Trust — Christchurch
• Tauranga Urology Research Ltd — Tauranga

Болгария · 1 центр

• The Hill Clinic — Sofia

Идентификаторы

NCT: NCT07741656 · ASTRA 2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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