C.L.E.A.R. - Comparing UroLift Experience Against Rezūm

Comparing UroLift Experience Against Rezūm

Sponsors

Lead sponsor: NeoTract, Inc.

Source NeoTract, Inc.
Brief 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.

Detailed Description

Patients will be randomized to either the UroLift or Rezum arm. Approximately 72-96 hours 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 2 weeks, 1 month, 3 months and 12 months post-procedure.

Overall Status Not yet recruiting
Start Date June 2020
Completion Date January 2022
Primary Completion Date December 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Subjects are catheter independent as assessed on post-operative Day 3. Day 3
Enrollment 120
Condition
Intervention

Intervention type: Device

Intervention name: UroLift

Description: 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.

Arm group label: UroLift

Intervention type: Device

Intervention name: Rezum

Description: 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.

Arm group label: Rezūm

Eligibility

Criteria:

Inclusion Criteria:

1. Male gender

2. Age ≥ 50 years

3. Diagnosis of symptomatic BPH

4. Prostate volume 30cm3 ≤ 80cm3

5. Willing to sign study informed consent form

6. Willing to comply with follow-up requirements

Exclusion Criteria:

1. Current urinary tract infection

2. Current urinary retention

3. Urethra conditions that may prevent insertion of delivery system into bladder

4. Previous BPH surgical procedure

5. Urinary incontinence due to incompetent sphincter

6. Current gross hematuria

7. Patients with a urinary sphincter implant

8. Patients who have a penile prosthesis

Gender: Male

Gender based: Yes

Gender description: Patients must be male. The study is evaluation the population of men diagnosed with benign prostatic hyperplasia.

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Contact

Last name: Emily Friedland

Phone: 925-387-6014

Email: [email protected]

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: UroLift

Arm group type: Experimental

Description: Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure.

Arm group label: Rezūm

Arm group type: Experimental

Description: Patient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure.

Acronym CLEAR
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov