NCT03167294

Brief Summary

Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

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

December 11, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

December 14, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

December 11, 2014

Last Update Submit

November 13, 2017

Conditions

Benign Prostatic Hyperplasia

Keywords

AquablationAQUABEAMBPHLUTS

Outcome Measures

Primary Outcomes (2)

  • Primary Device Performance Endpoint

    The primary device performance endpoint is completion of the intended surgical procedure.

    6 months

  • Primary Safety Endpoint of the study is the perioperative complication rate.

    The primary safety endpoint of the study is the perioperative complication rate

    6 months

Study Arms (1)

Single Arm

OTHER

AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH

Device: AquaBeam System

Interventions

AquaBeam SystemDEVICE

Aquablation

Single Arm

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • years
  • Moderate to severe BPH
  • Subjects who have failed standard medical therapy

You may not qualify if:

  • Size and width of prostate
  • Medical condition or co-morbidities where BPH intervention would be contraindicated

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

    Chairman, department of Urology 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

December 11, 2014

First Posted

May 25, 2017

Study Start

December 14, 2014

Primary Completion

June 30, 2016

Study Completion

April 27, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

IN(1)