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

Обзор

Robotic assisted surgery for benign prostatic hyperplasia (BPH)

Подробное описание

A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.

Вмешательства

• Устройство Beacon Platform
  The Beacon Platform is a robotically assisted surgical (RAS) device. It enables the urologist, through software, to control and move surgical instruments for a variety of transurethral, endoscopic procedures

Первичные конечные точки

• Number of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion [Срок оценки: During the procedure.]
• Number of subjects with adverse events ( Clavien-Dindo Grade 3a or higher ) [Срок оценки: From procedure date to 30 days]

Вторичные конечные точки (7)

• Number of Participants with Capsular Perforation Leading to Procedure Interruption or Conversion [Срок оценки: From procedure date to 30 days.]
• Number of Participants with Bladder Perforation Leading to Procedure Interruption or Conversion [Срок оценки: From procedure date to 30 days.]
• Number of Participants with Ureteric Orifice Damage Requiring Intervention [Срок оценки: From procedure date to 30 days.]
• Length of Hospital Stay Post-Procedure [Срок оценки: From procedure date to 30 days]
• Length of Catheterization Post-Procedure [Срок оценки: From procedure date to 30 days]
• Operative Time for Procedure Completion [Срок оценки: During the procedure.]
• Number of Participants with Repeat Hospitalization for Genitourinary Conditions [Срок оценки: From procedure date to 30 days post-procedure.]

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 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

Критерии исключения

• 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

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

• Universidad Catolica de Chile — Santiago
• Hospital Clínico de la Universidad de Chile — Santiago

Новая Зеландия · 1 центр

• Tauranga Urology Research Limited — Tauranga

Публикации

• Shvero A, Kloniecke E, Capella C, Das AK. HoLEP techniques - lessons learned. Can J Urol. 2021 Aug;28(S2):11-16. PMID 34453423
• Abedi A, Razzaghi MR, Rahavian A, Hazrati E, Aliakbari F, Vahedisoraki V, Allameh F. Is Holmium Laser Enucleation of the Prostate a Good Surgical Alternative in Benign Prostatic Hyperplasia Management? A Review Article. J Lasers Med Sci. 2020 Spring;11(2):197-203. doi: 10.34172/jlms.2020.33. Epub 2020 Mar 15. PMID 32273963
• Das AK, Han TM, Hardacker TJ. Holmium laser enucleation of the prostate (HoLEP): size-independent gold standard for surgical management of benign prostatic hyperplasia. Can J Urol. 2020 Aug;27(S3):44-50. PMID 32876002
• Das AK, Teplitsky S, Humphreys MR. Holmium laser enucleation of the prostate (HoLEP): a review and update. Can J Urol. 2019 Aug;26(4 Suppl 1):13-19. PMID 31481144

Идентификаторы

NCT: NCT06668142 · ASTRA112024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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