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ROBUST I Pilot Study (ROBUST)

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: NCT03014726
Recruitment Status : Active, not recruiting
First Posted : January 9, 2017
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Urotronic Inc.

Brief Summary:
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.

Condition or disease Intervention/treatment Phase
Stricture Urethra Device: Urotronic Drug Coated Balloon (DCB) Not Applicable

Detailed Description:

The study is designed to determine the safety and effectiveness for drug coated balloon (DCB).

Up to 50 subjects is planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Due to significantly higher prevalence of strictures in men vs. women and the etiology of those strictures being different, the study will focus on male subjects with single anterior urethral stricture. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ROBUST I Pilot Study, ROBUST I Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Study Start Date : November 2016
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: DCB Treatment
Stricture patients treated by DCB
Device: Urotronic Drug Coated Balloon (DCB)
Urotronic Drug Coated Balloon (DCB) is a catheter with a tapered atraumatic tip. The distal end of the catheter has a semi-compliant inflatable balloon coated with a proprietary coating containing the drug and carriers.




Primary Outcome Measures :
  1. Rate of Treatment Related Serious Complication [ Time Frame: 90 days post-procedure ]
    Device related formation of fistula; Device related de novo severe urinary retention


Secondary Outcome Measures :
  1. Stricture Recurrence Rate [ Time Frame: 90 days post-procedure ]
    Improvement in IPSS (International Prostate Symptoms Score)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male subjects ≥ 18 years' old
  2. Visual confirmation of stricture via cystoscopy or urethrogram
  3. Single lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm
  4. One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) including DVIU (Direct Vision Internal Urethrotomy), but no prior urethroplasty
  5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's.
  6. IPSS score of 13 or higher
  7. Lumen diameter <12F by urethrogram
  8. Able to complete validated questionnaire independently
  9. Qmax <10 ml/sec

Exclusion Criteria:

  1. Strictures greater than 2.0 cm long.
  2. Subjects that have more than 1 stricture.
  3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
  4. Subjects who have a suprapubic catheter and are unable to complete study required testing, such as uroflowmetry
  5. Previous urethroplasty within the anterior urethra
  6. Stricture due to bacterial urethritis or untreated gonorrhea
  7. Stricture dilated or incised within the last 3 months
  8. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.
  9. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture such as BPH at the discretion of the clinical investigator
  10. Previous radical prostatectomy
  11. Previous pelvic radiation
  12. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
  13. Diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level greater than 2 mg/dL
  14. Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months.)
  15. Use of Botox (onabotulinumtoxinA) in urinary system within the last 12 months

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): NCT03014726


Locations
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United States, Minnesota
Libra Medical Inc
Brooklyn Park, Minnesota, United States, 55428
Sponsors and Collaborators
Urotronic Inc.
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Responsible Party: Urotronic Inc.
ClinicalTrials.gov Identifier: NCT03014726    
Other Study ID Numbers: DSC016
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Urotronic Inc.:
reduced urine flow rate
low peak flow rate
urinary tract infections
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical