Benign Prostatic HyperplasiaCLEARNCT04338776
Comparing UroLift Experience Against Rezūm
A study testing UroLift and Rezum in people with Benign Prostatic Hyperplasia, run by NeoTract, Inc. at 10 sites in 2 countries.
Trial summary
C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- UroLift and Rezum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 22 Jan 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male gender
- Age ≥ 50 years
- Diagnosis of symptomatic BPH
- Prostate volume 30cm3 ≤ 80cm3
- Willing to sign study informed consent form
Who cannot join
- Current urinary tract infection
- Current catheter dependent urinary retention or PVR >= 500 mL
- Urethra conditions that may prevent insertion of delivery system into bladder
- Previous BPH surgical procedure
- Urinary incontinence presumed due to incompetent sphincter
- Current gross hematuria
Show all 9Show fewer
- Patients with a urinary sphincter implant
- Patients who have a penile prosthesis
- Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Urology Austin
Austin, Texas, 78759
UT Southwestern Medical Center
Dallas, Texas, 75048
NYU Winthrop Urology
Garden City, New York, 11530
Tower Urology
Los Angeles, California, 90048
Weil Cornell Medical College, Cornell University
New York, New York, 10065
Comprehensive Urology
Royal Oak, Michigan, 48073
Urology San Antonio
San Antonio, Texas, 78229
United Kingdom3 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Frimley Park Hospital
Frimley, Camberley, 6U167UJ UK
NORFOLK and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
About this study
Official title: C.L.E.A.R. - Comparing UroLift Experience Against Rezūm
C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months.
Read the detailed description
Patients will be randomized to either the UroLift or Rezum arm. Post-procedure, subjects who receive a catheter between post-procedure and prior to discharge, will return to office to complete a voiding assessment.
All subjects will be expected to complete questionnaires and assessments, as part of SOC (varies by institution), at day 3, day 7, 2 weeks, 1 month, 3 months and 12 months post-procedure.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- UroLift, Rezum
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroLiftDevice
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).
During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.
RezumDevice
The Rezūm™ System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH.
The Rezūm System is manufactured by Boston Scientific and consists of a radiofrequency (RF) generator and a single-use transurethral delivery device.
The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released,reducing the volume tissue adjacent to the urethra.
| Study group | Role | What they receive |
|---|---|---|
| UroLift | Experimental | Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure. Receives: Device: UroLift |
| Rezūm | Experimental | Patient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure. Receives: Device: Rezum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter Independent
Number of subjects who are catheter independent and remain catheter independent through 1-week
Measured: Through 1-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start22 Jan 2021
- Primary completion5 Jun 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeoTract, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338776
- Sponsor's protocol ID
- CP00013
- Acronym
- CLEAR
- Status last verified
- Oct 2025
- First submitted
- 2 Apr 2020
- Last updated
- 14 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C.L.E.A.R. - Comparing UroLift Experience Against Rezūm
- ClinicalTrials.gov ID
- NCT04338776
- Acronym / sponsor ID
- CLEAR / CP00013
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- NeoTract, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months.
Detailed description
Patients will be randomized to either the UroLift or Rezum arm. Post-procedure, subjects who receive a catheter between post-procedure and prior to discharge, will return to office to complete a voiding assessment.
All subjects will be expected to complete questionnaires and assessments, as part of SOC (varies by institution), at day 3, day 7, 2 weeks, 1 month, 3 months and 12 months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UroLift | Experimental | Device: UroLiftPatient randomized to the UroLift arm will receive the FDA-approved UroLift procedure. |
| Rezūm | Experimental | Device: RezumPatient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male gender
- Age ≥ 50 years
- Diagnosis of symptomatic BPH
- Prostate volume 30cm3 ≤ 80cm3
- Willing to sign study informed consent form
Key exclusion criteria (9 listed)
- Current urinary tract infection
- Current catheter dependent urinary retention or PVR >= 500 mL
- Urethra conditions that may prevent insertion of delivery system into bladder
- Previous BPH surgical procedure
- Urinary incontinence presumed due to incompetent sphincter
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 |
|---|---|---|
| UroLiftThe UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra. | Device | UroLift |
| RezumThe Rezūm™ System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. The Rezūm System is manufactured by Boston Scientific and consists of a radiofrequency (RF) generator and a single-use transurethral delivery device. The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released,reducing the volume tissue adjacent to the urethra. | Device | Rezūm |
Primary outcome
Catheter Independent
Time frame: Through 1-week
Number of subjects who are catheter independent and remain catheter independent through 1-week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UroLift and Rezum in people with Benign Prostatic Hyperplasia, run by NeoTract, Inc. at 10 sites in 2 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Catheter Independent (time frame: Through 1-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2025; AzTrials last refreshed its copy on 29 Oct 2026.