Benign Prostatic Hyperplasia (BPH)WATERNCT02505919

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)

A study testing AQUABEAM System and Transurethral Resection of the Prostate (TURP) in people with Benign Prostatic Hyperplasia (BPH), run by PROCEPT BioRobotics at 17 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 45 to 80 years, men only
Conditions the study is for: Benign Prostatic Hyperplasia (BPH)
What is being tested?: AQUABEAM System and Transurethral Resection of the Prostate (TURP)
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 17 sitesin 4 countries
Study dates: 30 Oct 2015to 16 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
Age from 45 to 80 years.
Subject has medical record documentation of a prostate volume between 30mL and 80mL (inclusive) by transrectal ultrasound (TRUS). (If TRUS testing documentation is available from less than 180 days prior to the informed consent date and the prostate volume is between 30mL and 80mL, it may be used for the inclusion/exclusion criteria.)
Subject has an International Prostate Symptom Score (IPSS) score greater than or equal to 12 measured at the baseline visit.
Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15mL/s. (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 125mL, and the Qmax is less than 15mL/s it may be used for the inclusion/exclusion criteria.)
Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured ≤ 30 days prior to the date of surgery.
History of inadequate response, contraindication, or refusal to medical therapy.

Who cannot join

Body Mass Index (BMI) ≥ 42.
History of prostate cancer or current/suspected bladder cancer.
Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds.
Subjects with a history of actively treated bladder cancer within the past two (2) years.
Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size).
Active infection, including urinary tract infection.

Show all 21Show fewer

Prostatitis treated with antibiotics within 1 year of enrollment.
Ever been diagnosed with a urethral stricture, meatal stenosis, or bladder neck contracture.
Subject has damage to external urinary sphincter .
Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use.
Post-Void Residual (PVR) > 300 mL.
Urinary retention at time of enrollment or subject has been catheterized in the 14 days prior to the surgical procedure.
Subject has a history of intermittent self-catheterization.
Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.
Subjects on anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d).
Any severe illness that would prevent complete study participation or confound study results.
Participants using systematic immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents (Nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than or equal to 100mg).
Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
Contraindication to general or spinal anesthesia.
Subject has any other disease or condition(s) that would interfere with completion of the study and follow up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes.
Subject is unwilling to accept a transfusion should one be required.

Trial locations and contacts

17 sites in 4 countries.

Country

City, postcode or hospital

17 sites in 4 countries

United States12 sites

Albany Medical College
Albany, New York, 12208
Urology Centers of Alabama
Birmingham, Alabama, 35209
University of Vermont College of Medicine
Burlington, Vermont, 05401
UT Southwestern Medical Center
Dallas, Texas, 75390-9110
Urology Associates, P.C.
Englewood, Colorado, 80113
Houston Metro Urology
Houston, Texas, 77030
San Diego Clinical Trials
La Mesa, California, 91942
University of Southern California, Institute of Urology
Los Angeles, California, 90089
Weill Cornell Medical College
New York, New York, 10065
Adult & Pediatric Urology P.C.
Omaha, Nebraska, 68114
Virginia Urology
Richmond, Virginia, 23235
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157

Other trials in United States

United Kingdom3 sites

Princess of Wales Hospital
Bridgend, Wales, CF31 1RQ
Addenbrooke's Treatment Center
Cambridge, CB2 0QQ
Frimley Park Hospital
Frimley, Surrey, GU16 7UJ

Other trials in United Kingdom

Australia1 site

Royal Melbourne Hospital
Melbourne, Victoria, 3050

Other trials in Australia

New Zealand1 site

Tauranga Urology Research Ltd.
Tauranga, 3112

Other trials in New Zealand

About this study

Official title: A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS

A prospective multicenter randomized blinded study comparing Aquablation of the prostate with the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The primary endpoints for safety and effectiveness were measured at 3 and 6 months, respectively, and subjects were followed out to 5 years to collect long-term clinical data.

Conditions: Benign Prostatic Hyperplasia (BPH)
Being tested: AQUABEAM System, Transurethral Resection of the Prostate (TURP)
Keywords: Lower Urinary Tract Symptoms (LUTS)
Medical subject headings: Prostatic Hyperplasia, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AQUABEAM SystemDevice
The AQUABEAM system, a personalized image-guided tissue removal system, utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue.
Transurethral Resection of the Prostate (TURP)Procedure or surgery
Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)

Study groups in NCT02505919
Study group	Role	What they receive
Treatment	Experimental	AQUABEAM System Receives: Device: AQUABEAM System
Active Comparator	Active comparator	Transurethral Resection of the Prostate (TURP) Receives: Procedure: Transurethral Resection of the Prostate (TURP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)
The primary safety endpoint is the proportion of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment. Note that the Clavien-Dindo classification scheme is for grading postoperative complications not events that reflect lack of effective treatment. Results are presented as a percentage rounded to the whole number.
Measured: Three months post-treatment
Change Score of IPSS Questionnaire Between Baseline and 6 Months
The primary effectiveness endpoint is the IPSS change score from baseline to 6 months.
International Prostate Symptom Score (IPSS) ranges from 0 to 35. A higher score indicates a worse outcome.
Measured: Six months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 201516 Dec 2021

First posted22 Jul 2015 (estimated)
Study start30 Oct 2015
Primary completion14 Jul 2017
Study completion16 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02505919
Sponsor's protocol ID: TP0038
Acronym: WATER
Status last verified: Jun 2023
First submitted: 21 Jul 2015
Last updated: 3 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation(R) vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia. J Urol. 2018 May;199(5):1252-1261. doi: 10.1016/j.juro.2017.12.065. Epub 2018 Jan 31.
PubMed 29360529
Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Roehrborn C. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes. Urology. 2019 Mar;125:169-173. doi: 10.1016/j.urology.2018.12.002. Epub 2018 Dec 12.
PubMed 30552937
Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. Adv Ther. 2019 Jun;36(6):1326-1336. doi: 10.1007/s12325-019-00952-3. Epub 2019 Apr 26.
PubMed 31028614
Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial. Can J Urol. 2020 Feb;27(1):10072-10079.
PubMed 32065861
Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Kaufman RP Jr, Badlani G, Plante M, Desai M, Doumanian L, Te AE, Roehrborn CG. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. Can J Urol. 2022 Feb;29(1):10960-10968.
PubMed 35150215
Pimentel MA, Yassaie O, Gilling P. Urodynamic Outcomes After Aquablation. Urology. 2019 Apr;126:165-170. doi: 10.1016/j.urology.2019.01.020. Epub 2019 Feb 2.
PubMed 30721737
Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc). Adv Ther. 2018 Jun;35(6):832-838. doi: 10.1007/s12325-018-0722-0. Epub 2018 Jun 5.
PubMed 29873008

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
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All Benign Prostatic Hyperplasia (BPH) trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS
ClinicalTrials.gov ID: NCT02505919
Acronym / sponsor ID: WATER / TP0038
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Lower Urinary Tract Symptoms (LUTS)
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: PROCEPT BioRoboticsIndustry (pharma, biotech, devices)
Study start: 30 Oct 2015 (actual)
Primary completion: 14 Jul 2017 (actual)
Study completion: 16 Dec 2021 (actual)
First posted: 22 Jul 2015 (estimated)
Results: Posted 8 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Device: AQUABEAM SystemAQUABEAM System
Active Comparator	Active comparator	Procedure: Transurethral Resection of the Prostate (TURP)Transurethral Resection of the Prostate (TURP)

Who may qualify

Ages: 45 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
Age from 45 to 80 years.
Subject has medical record documentation of a prostate volume between 30mL and 80mL (inclusive) by transrectal ultrasound (TRUS). (If TRUS testing documentation is available from less than 180 days prior to the informed consent date and the prostate volume is between 30mL and 80mL, it may be used for the inclusion/exclusion criteria.)
Subject has an International Prostate Symptom Score (IPSS) score greater than or equal to 12 measured at the baseline visit.
Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15mL/s. (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 125mL, and the Qmax is less than 15mL/s it may be used for the inclusion/exclusion criteria.)

Key exclusion criteria (21 listed)

Body Mass Index (BMI) ≥ 42.
History of prostate cancer or current/suspected bladder cancer.
Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds.
Subjects with a history of actively treated bladder cancer within the past two (2) years.
Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AQUABEAM SystemThe AQUABEAM system, a personalized image-guided tissue removal system, utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue.	Device	Treatment
Transurethral Resection of the Prostate (TURP)Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)	Procedure or surgery	Active Comparator

Primary outcome

Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)
Time frame: Three months post-treatment
The primary safety endpoint is the proportion of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment. Note that the Clavien-Dindo classification scheme is for grading postoperative complications not events that reflect lack of effective treatment. Results are presented as a percentage rounded to the whole number.
Change Score of IPSS Questionnaire Between Baseline and 6 Months
Time frame: Six months post-treatment
The primary effectiveness endpoint is the IPSS change score from baseline to 6 months. International Prostate Symptom Score (IPSS) ranges from 0 to 35. A higher score indicates a worse outcome.

Results and safety

Results posted to the registry on 8 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	116	116
Active Comparator	65	65

Primary outcome: Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)

Time frame: Three months post-treatment. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Treatment n = 116	Active Comparator n = 65
Value	26 (18.2 to 34.8)	42 (29.4 to 54.4)

Primary outcome: Change Score of IPSS Questionnaire Between Baseline and 6 Months

Time frame: Six months post-treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment n = 114	Active Comparator n = 62
Value	-16.9 (6.6)	-15.1 (7.9)

Population analysed: The variation between the overall number of participants analyzed for this outcome and the completed number on the participant flow at this follow-up is due to this specific outcome assessment not being done by all participants who completed this follow-up.

Adverse events

Time frame: 5 years. Other adverse events reported at 1.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	24 of 116 (20.7%)	75 of 116 (64.7%)	4 of 116
Active Comparator	14 of 65 (21.5%)	53 of 65 (81.5%)	1 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29360529Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation(R) vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia. J Urol. 2018 May;199(5):1252-1261. doi: 10.1016/j.juro.2017.12.065. Epub 2018 Jan 31.
Background: PubMed 30552937Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Roehrborn C. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes. Urology. 2019 Mar;125:169-173. doi: 10.1016/j.urology.2018.12.002. Epub 2018 Dec 12.
Background: PubMed 31028614Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. Adv Ther. 2019 Jun;36(6):1326-1336. doi: 10.1007/s12325-019-00952-3. Epub 2019 Apr 26.
Background: PubMed 32065861Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial. Can J Urol. 2020 Feb;27(1):10072-10079.
Background: PubMed 35150215Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Kaufman RP Jr, Badlani G, Plante M, Desai M, Doumanian L, Te AE, Roehrborn CG. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. Can J Urol. 2022 Feb;29(1):10960-10968.
Derived from this study: PubMed 30721737Pimentel MA, Yassaie O, Gilling P. Urodynamic Outcomes After Aquablation. Urology. 2019 Apr;126:165-170. doi: 10.1016/j.urology.2019.01.020. Epub 2019 Feb 2.
Derived from this study: PubMed 29873008Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc). Adv Ther. 2018 Jun;35(6):832-838. doi: 10.1007/s12325-018-0722-0. Epub 2018 Jun 5.

Related trials for Benign Prostatic Hyperplasia (BPH)

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
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Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Gilling, M.D. principal investigator

Urology BOP

Claus Roehrborn, M.D. principal investigator

University of Texas Southwestern Medical Center

17 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AQUABEAM System and Transurethral Resection of the Prostate (TURP) in people with Benign Prostatic Hyperplasia (BPH), run by PROCEPT BioRobotics at 17 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, United Kingdom, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability) (time frame: Three months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02505919, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.