This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters (STREAM)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05383274
Recruitment Status : Recruiting
First Posted : May 20, 2022
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
Urotronic Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.

Condition or disease Intervention/treatment Phase
Urethral Stricture Combination Product: Optilume Urethral DCB Phase 4

Detailed Description:
Male subject diagnosed with a stricture in the anterior urethra that can be treated with the Optilume Urethral DCB. Thirty-Four (34) subjects will be enrolled at up to ten (10) sites in the United States. Clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months post-treatment evaluating Lower Urinary Tract Symptoms (LUTS), sexual function, and voiding function. Semen quality parameters will be assessed at Baseline, 3 months, and 6 months post-treatment. Subjects with an abnormal semen quality result at 6 months will have an additional assessment at 12 months post-treatment and periodically thereafter until results return to normal.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Actual Study Start Date : February 14, 2022
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : August 30, 2024
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Optilume Urethral DCB
The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
 Combination Product: Optilume Urethral DCB
The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Primary Safety Endpoint [ Time Frame: 3-months ]
    Average Change in Sperm Concentration from baseline to 3-months


Secondary Outcome Measures :
  1. Secondary Safety Endpoint [ Time Frame: 6-months ]
    Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men between 22 and 65 years of age.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male subjects between 22 and 65 years of age
  2. Subject diagnosed with a stricture in the anterior urethra that is able to be treated with the Optilume Urethral DCB in accordance with the approved Instructions for Use
  3. Subject is willing to provide written informed consent and comply with study required follow-up assessments

  4. Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):

    1. total sperm ≥39 million
    2. sperm concentration ≥15 million/mL
    3. total motility ≥40%
    4. progressive motility ≥32%
    5. morphology ≥4%

Exclusion Criteria:

  1. Subjects with a known hypersensitivity to paclitaxel or structurally related compounds
  2. Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
  3. Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
  4. Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
  5. Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
  6. History of cancer in any body system that is not considered in complete remission
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05383274


Contacts
Layout table for location contacts
Contact: Brenda Johnson 17632857488 johnsonb@urotronic.com

Locations
Layout table for location information
United States, Florida
Florida Urology Recruiting
Tampa, Florida, United States, 33615
Contact: Osvaldo Padron, MD         
United States, Louisiana
Regional Urology Recruiting
Shreveport, Louisiana, United States, 71106
Contact: Jared Moss, MD         
United States, Maryland
Chesapeake Recruiting
Hanover, Maryland, United States, 21076
Contact: Kaiser Robertson III, MD         
United States, New Jersey
New Jersey Urolgy Recruiting
Millburn, New Jersey, United States, 07041
Contact: Karl Coutinho, MD         
United States, New York
Western New York Recruiting
Cheektowaga, New York, United States, 14225
Contact: Kent Chevli, MD         
Sponsors and Collaborators
Urotronic Inc.
Investigators
Layout table for investigator information
Principal Investigator: Karl Coutinho, MD New Jersey Urology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Urotronic Inc.
ClinicalTrials.gov Identifier: NCT05383274    
Other Study ID Numbers: PR1275
First Posted: May 20, 2022    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Urethral Stricture
Urethral Obstruction
Urethral Diseases
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases