Global Post-Market Registry Using Waterjet Ablation Thera... | NCT02974751

Studies
Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

NCT02974751

Sponsor

PROCEPT BioRobotics

Status

Unknown status

Last Update Posted

Oct 22, 2019Actual

Enrollment

178Actual

Phase

Not provided

Conditions

Interventions

Aquablation

Countries

Australia
Germany
Lebanon
New Zealand
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2017Actual

Primary Completion Date

May 24, 2019Actual

Completion Date

Feb 29, 2020Estimated

First Submitted Date

Nov 23, 2016

First Submission Date that Met QC Criteria

Nov 23, 2016

First Posted Date

Nov 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2019

Last Update Posted Date

Oct 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia (BPH).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

178Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aquablation	Procedure	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.

Measure	Description	Time Frame
IPSS score change		3 months

Eligibility Module

Eligibility Criteria

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.

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participants with lower urinary tract symptoms, including those with urinary retention, who meet all other enrollment criteria.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Royal Melbourne Hospital		Melbourne	Victoria	3050	Australia
Asklepios Klinikum Harburg

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000098944	Aquablation

Ancestor Terms

ID	Term
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative
D011468	Prostatectomy
D013521	Urologic Surgical Procedures, Male

Browse Leaves

Not provided

Browse Branches

Not provided