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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02974751




Registration number
NCT02974751
Ethics application status
Date submitted
23/11/2016
Date registered
28/11/2016

Titles & IDs
Public title
Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Scientific title
Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Secondary ID [1] 0 0
TP0118
Universal Trial Number (UTN)
Trial acronym
OPEN WATER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
BPH 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Aquablation

Treatment: Surgery: Aquablation
Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
IPSS score change
Timepoint [1] 0 0
3 months

Eligibility
Key inclusion criteria
* Male.
* Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction or in urinary retention.
* Prostate size = 20 mL and = 150 mL as measure by TRUS.
* Patient is mentally capable and willing to sign a study-specific informed consent form.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
* History of gross haematuria.
* Participants using systemic immune-suppressants including corticosteroids (except inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d).
* Contraindication to both general and spinal anesthesia.
* Any severe illness that would prevent complete study participation or confound study results.
* Subject is unwilling to accept a transfusion should one be required.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/02/2020
Actual
Sample size
Target
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Hamburg
Country [2] 0 0
Lebanon
State/province [2] 0 0
Beirut
Country [3] 0 0
New Zealand
State/province [3] 0 0
Tauranga
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PROCEPT BioRobotics
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02974751