Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000167763
Ethics application status
Approved
Date submitted
8/02/2013
Date registered
12/02/2013
Date last updated
1/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Aquablation Pilot Study for the treatment of Benign Prostatic Hyperplasia.
Scientific title
Single-arm prospective, interventional pilot study to evaluate the safety, feasibility and efficacy of the PROCEPT AquablationTM System (PAS) device for the treatment of Benign Prostatic Hyperplasia (BPH)
Secondary ID [1] 281845 0
Nil
Universal Trial Number (UTN)
U1111-1135-6806
Trial acronym
APS – Aquablation Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia (BPH) otherwise known as enlarged prostate due to benign growth of glandular tissue 288206 0
Condition category
Condition code
Surgery 288574 288574 0 0
Surgical techniques
Renal and Urogenital 288575 288575 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PROCEPT Aquablation(TM) System (PAS) is intended to remove prostate tissue as a treatment for Benign Prostatic Hyperplasia (BPH).
The transurethral procedure involves the delivery of a high pressure water jet that cuts through tissue without thermal injury.
A dedicated surgical laser (the AquabeamTM), delivered through a column of water coagulates bleeding tissues.
The approximate duration of this procedure is 60 minutes.
Intervention code [1] 286405 0
Treatment: Surgery
Intervention code [2] 286406 0
Treatment: Devices
Comparator / control treatment
Not applicable. This is a single arm study with no comparator or control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288728 0
To evaluate the performance of the PAS device for the treatment of BPH. This outcome is assessed with a 5 point Likert Scale.
Timepoint [1] 288728 0
Completion of the intended surgical procedure.
Primary outcome [2] 288785 0
Incidence and Severity of Adverse Events. Anticipated adverse events might include prolonged catheterisation and haematuria. Based on ICH GCP Guidelines, AES are graded based on severity (mild, moderate, severe), relatedness to the device (definitely, likely, unlikely, definitely not) , relatedness to the procedure (as for device), and outcome (recovered, recovering, recovered with sequelae, ongoing). All Adverse events are documented, assessed by the investigator for severity, duration and frequency and reviewed by an Independent Assessor.
Timepoint [2] 288785 0
Procedure up until 3 years. A protocol amendment will now require follow up for 36 months with assessments at treatment, post procedure, 1 week, 1 month, 3 month 6 month and annual visits at 12, 24 and 36 months.
Secondary outcome [1] 300852 0
Change from baseline in IPSS (International Prostate Symptom Score) and IIEF (International Index of Erectile Function)
Timepoint [1] 300852 0
Post procedure, one week, One, Three, Six, twelve, twenty four and forty eight months.
Secondary outcome [2] 300853 0
Change from baseline in peak urinary flow rate, post-void residual volume and PDet/Qmax (Schaffer grade). These outcome measures are assessed using Uroflowmetry, Urodynamics and Ultrasound procedures.
Timepoint [2] 300853 0
Post procedure, one week, One, Three, Six, twelve, twenty four and forty eight months.
Secondary outcome [3] 300854 0
Change in prostate volume as determined via trans rectal ultrasound.
Timepoint [3] 300854 0
6 months

Eligibility
Key inclusion criteria
Male, Age > 50 years with BPH and history of inadequate response to medical therapy.
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Large median lobe, urethral length >6cm, prostates >80g, prostate cancer, current urological conditions affecting procedural outcomes, previous prostate surgery, significant renal impairment, listed concomitant medications and listed uncontrolled co-morbidities.










Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Continuous outcomes will be summarised with mean, standard deviation and other relevant statistically summaries. When not normally distributed, medians and quantiles will be reported. A confidence interval approach may be used, if appropriate, to compare outcomes with historical information.
.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/01/2013
Actual
18/01/2013
Date of last participant enrolment
Anticipated
31/07/2013
Actual
21/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 2298 0
Mount Hospital - Perth
Recruitment hospital [2] 2299 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment outside Australia
Country [1] 4824 0
New Zealand
State/province [1] 4824 0
Tauranga

Funding & Sponsors
Funding source category [1] 286629 0
Commercial sector/Industry
Name [1] 286629 0
PROCEPT BioRobotics Corporation
Country [1] 286629 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
PROCEPT BioRobotics Corporation
Address
900 Island Drive, Suite 101, Redwood Shores CA 94065
Country
United States of America
Secondary sponsor category [1] 285414 0
Commercial sector/Industry
Name [1] 285414 0
Five Corners Pty Ltd
Address [1] 285414 0
13/76 Reserve Rd
Artarmon
NSW 2064
Country [1] 285414 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288707 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 288707 0
Ethics committee country [1] 288707 0
New Zealand
Date submitted for ethics approval [1] 288707 0
31/10/2012
Approval date [1] 288707 0
14/01/2013
Ethics approval number [1] 288707 0
12/CEN/63
Ethics committee name [2] 291740 0
Mount Hospital Ethics Committee
Ethics committee address [2] 291740 0
Ethics committee country [2] 291740 0
Australia
Date submitted for ethics approval [2] 291740 0
09/09/2013
Approval date [2] 291740 0
09/01/2014
Ethics approval number [2] 291740 0
EC77.1
Ethics committee name [3] 291741 0
Melbourne Health
Ethics committee address [3] 291741 0
Ethics committee country [3] 291741 0
Australia
Date submitted for ethics approval [3] 291741 0
30/10/2013
Approval date [3] 291741 0
21/02/2014
Ethics approval number [3] 291741 0
2013.282

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37366 0
A/Prof Peter Gilling
Address 37366 0
Tauranga Urology Research Limited
Suite 6, Promed House,
71 Tenth Avenue
Tauranga, New Zealand, 3110
Country 37366 0
New Zealand
Phone 37366 0
64 (0)7 577 77 95
Fax 37366 0
64(0)7 579 0468
Email 37366 0
[email protected]
Contact person for public queries
Name 37367 0
Rana Reuther
Address 37367 0
Tauranga Urology Research Limited, Suite 6, Level 1, Virtuoso, 850 Cameron Road, Tauranga. New Zealand
Country 37367 0
New Zealand
Phone 37367 0
64 (0)7 577 7795
Fax 37367 0
64 (0)7 579 0468
Email 37367 0
[email protected]
Contact person for scientific queries
Name 37368 0
Nikolai Aljuri
Address 37368 0
PROCEPT BioRobotics Corporation,
900 Island Drive, Suite 101, Redwood Shores CA 94065 USA
Country 37368 0
United States of America
Phone 37368 0
+1 650 232 5797
Fax 37368 0
+1 650 362 1917
Email 37368 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.