Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia III

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: AQUABEAM System followed by catheter without hemostatic agent; Device: AQUABEAM System followed by catheter with hemostatic agent

• Registration Number: NCT04308070
• Lead Sponsor: PROCEPT BioRobotics

Brief Summary

A dual-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with catheters along with the use or absence of a hemostatic agent following treatment with the AQUABEAM System.

Detailed Description

PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis using balloon catheters with and without hemostatic agents following prostate resection using AQUABEAM for the treatment of LUTS resulting from BPH. Up to 50 participants will be included in the trial at one clinical study site. All patients will be followed up for 3 months for safety assessment prior to study exit. The trial is a dual-arm prospective, interventional clinical trial.

Study Timeline

• Study Start: 2017-07-18
• Study First Submitted: 2017-10-04
• Primary Completion: 2018-03-22
• Study Completion: 2018-06-30
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Study First Posted: 2020-03-13
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

• Male
• BPH symptoms

Exclusion Criteria

• Serious concurrent medical conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter without Hemostatic Agent Following Aquablation	AQUABEAM System followed by catheter without hemostatic agent	AQUABEAM System followed by catheter without hemostatic agent
Catheter with Hemostatic Agent Following Aquablation	AQUABEAM System followed by catheter with hemostatic agent	AQUABEAM System followed by catheter with hemostatic agent

Primary Outcome Measures

Name	Time	Method
Number of subjects that do not require a transfusion and do not return to the operating room for hematuria management within 7 days following the index procedure.	7 days post-op	Adequate hemostasis post-Aquablation with the use of a urinary catheter and / or delivery of a hemostatic agent, measured by the number of subjects that, within 7 days following the index procedure, do not require a transfusion and do not return to the operating room for hematuria management.

Trial Locations

Locations (1)

Muljibhai Patel Urological Hospital; 🇮🇳 Nadiad, Gujarat, India