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

Not Applicable

Completed

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

• Registration Number: NCT03125863
• Lead Sponsor: PROCEPT BioRobotics

Brief Summary

A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters 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 Lower Urinary Tract Symptoms (LUTS) due to BPH. The AquaBeam System is intended for the resection and removal of prostate tissue in patients experiencing LUTS. The primary objective of the study is to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam. The time frame of the study is 7 days. Up to 30 participants will be included in this single-site clinical trial. The trial is a single-arm prospective, interventional clinical study. Results will be analyzed to determine the safety and efficacy of commercially approved catheters for the achievement of acute hemostasis without the need for cauterization.

Study Timeline

• Study First Submitted: 2016-08-09
• Study Start: 2016-08-26
• Primary Completion: 2016-09-03
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Study Completion: 2017-07-31
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

• Male age from 40 through 85 years with LUTS due to BPH

Exclusion Criteria

• Any severe illness that would prevent complete study participation or confound study results

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 enlarged prostatic tissue. Following the aquablation intervention, a urinary catheter will be inserted to apply pressure on treated tissue for hemostasis.

Primary Outcome Measures

Name	Time	Method
Completion of the intended surgical procedure	7 days post-op
Proportion of subjects that require electrocautery or any other intervention post catheter removal.	7 days post-op

Trial Locations

Locations (1)

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