NCT03125863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

August 26, 2016

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

8 days

First QC Date

August 9, 2016

Last Update Submit

November 10, 2017

Conditions

Benign Prostatic Hyperplasia

Keywords

Image-guidedBPHAquablationAQUABEAMLUTSTissue resectionRobotics

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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.

Device: AquaBeam System

Interventions

AquaBeam SystemDEVICE

The AquaBeam system delivers a high-velocity saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The AquaBeam ablates the target tissue, adhering to the pre-defined treatment zone.

Treatment Arm

Eligibility Criteria

Age40 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muljibhai Patel Urological Hospital

Nadiād, Gujarat, 387001, India

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ravindra Sabnis, MD

    Muljibhai Patel Urological Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

April 24, 2017

Study Start

August 26, 2016

Primary Completion

September 3, 2016

Study Completion

July 31, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

IN(1)