search
Back to results

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters (STREAM)

Primary Purpose

Urethral Stricture

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Optilume Urethral DCB
Sponsored by
Urotronic Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urethral Stricture

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male subjects between 22 and 55 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 WHO criteria (average of 2 samples):

    1. ejaculate volume ≥1.5mL
    2. total sperm ≥39 million
    3. sperm concentration ≥15 million/mL
    4. total motility ≥40%
    5. progressive motility ≥32%
    6. 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.
  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.

Sites / Locations

  • Florida UrologyRecruiting
  • Regional UrologyRecruiting
  • ChesapeakeRecruiting
  • New Jersey UrolgyRecruiting
  • Western New YorkRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optilume Urethral DCB

Arm Description

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.

Outcomes

Primary Outcome Measures

Primary Safety Endpoint
Average Change in Sperm Concentration from baseline to 3-months

Secondary Outcome Measures

Secondary Safety Endpoint
Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months

Full Information

First Posted
May 16, 2022
Last Updated
January 26, 2023
Sponsor
Urotronic Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05383274
Brief Title
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Acronym
STREAM
Official Title
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urotronic Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Optilume Urethral DCB
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Optilume Urethral DCB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint
Description
Average Change in Sperm Concentration from baseline to 3-months
Time Frame
3-months
Secondary Outcome Measure Information:
Title
Secondary Safety Endpoint
Description
Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months
Time Frame
6-months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Men between 22 and 65 years of age.
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male subjects between 22 and 65 years of age 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 Subject is willing to provide written informed consent and comply with study required follow-up assessments Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples): total sperm ≥39 million sperm concentration ≥15 million/mL total motility ≥40% progressive motility ≥32% morphology ≥4% Exclusion Criteria: Subjects with a known hypersensitivity to paclitaxel or structurally related compounds Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout Subject is unwilling to abstain or utilize a condom for 30 days after the procedure Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential History of cancer in any body system that is not considered in complete remission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brenda Johnson
Phone
17632857488
Email
johnsonb@urotronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Coutinho, MD
Organizational Affiliation
New Jersey Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Urology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osvaldo Padron, MD
Facility Name
Regional Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jared Moss, MD
Facility Name
Chesapeake
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaiser Robertson III, MD
Facility Name
New Jersey Urolgy
City
Millburn
State/Province
New Jersey
ZIP/Postal Code
07041
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl Coutinho, MD
Facility Name
Western New York
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kent Chevli, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

We'll reach out to this number within 24 hrs