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CLEAR Study: Evaluation of the Safety and Efficacy of the ClearRing System for the Treatment of BPH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04627701
Recruitment Status : Active, not recruiting
First Posted : November 13, 2020
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
ProArc Medical

Study Description
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Brief Summary:
The ProArc Medical ClearRing system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses an electrocutting blade to perform a circular incision, in which the implant is placed. The implant expands the obstructed area, and allows fluid flow through the prostatic urethra

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Device: ClearRing Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
Actual Study Start Date : July 19, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ClearRing Device Device: ClearRing
ClearRing Implantation


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in urinary related symptoms as evidenced by IPSS score [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male ≥45 years of age and ≤ 75 years old
  2. Diagnosed with symptomatic benign prostatic hyperplasia (BPH)
  3. International Prostate Symptom Score (IPSS) >13
  4. Participant understands and is willing to sign the informed consent form

Exclusion Criteria:

  1. Significant comorbidities which would affect study participation.
  2. Diagnosed or suspected prostate cancer.
  3. Active Urinary Tract Infection (UTI)
  4. Concomitant bladder or kidney stones
  5. Confirmed or suspected malignancy of bladder
  6. History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms
  7. Bacterial prostatitis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627701


Locations
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Israel
Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
ProArc Medical
More Information
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Responsible Party: ProArc Medical
ClinicalTrials.gov Identifier: NCT04627701    
Other Study ID Numbers: PA-CP-20
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
 Pathologic Processes
Prostatic Diseases
Urological Manifestations