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

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: AquaBeam System

• Registration Number: NCT03125889
• Lead Sponsor: PROCEPT BioRobotics

Brief Summary

A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis following prostate resection using the AQUABEAM for treatment of LUTS resulting from BPH.

Detailed Description

PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The AQUABEAM System is intended for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS).The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis with catheters 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 30 days for safety assessment prior to study exit. The trial is a single-arm prospective, interventional clinical trial.

Study Timeline

• Study First Submitted: 2017-03-14
• Study Start: 2017-04-10
• Primary Completion: 2017-04-18
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Study Completion: 2017-07-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

• Male
• BPH symptoms

Exclusion Criteria

• Serious concurrent medical conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	AquaBeam System	Subjects will receive treatment with the AquaBeam System to remove prostatic tissue.

Primary Outcome Measures

Name	Time	Method
Completion of the intended surgical procedure with adequate hemostasis	7 days post-op
Proportion of subjects who return to the OR for bleeding treatment or requires transfusion	7 days post-op

Trial Locations

Locations (1)

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