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ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease (ROBUST-III)

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ClinicalTrials.gov Identifier: NCT03499964
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
ClinLogix. LLC
Information provided by (Responsible Party):
Urotronic Inc.

Brief Summary:
ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).

Condition or disease Intervention/treatment Phase
Urethral Stricture Device: Optilume Drug Coated Balloon (DCB) Device: Control Treatment Not Applicable

Detailed Description:

ROBUST III is a prospective, multi-center, single blind randomized controlled clinical trial in a 2:1 allocation of treatment versus control device.

This study is an adaptive design with an interim analysis for sample size re-estimation performed after 60 subjects have been enrolled. The interim analysis will be be undertaken following completion of the 6-month follow-up data from these subjects. Based on the results of the interim analysis, the final total sample size required for the study will be re-estimated. A minimum of 140 subjects, and a maximum of 200 subjects (pending the re-estimation) will be enrolled in the study. A Data Monitoring Committee (DMC) will review the interim analysis results, including the sample size re-estimation and make recommendations related to trial continuation to the sponsor.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: ROBUST III - Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease - A Randomized Control Trial
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2024

Arm Intervention/treatment
Experimental: Optilume Treatment
The treatment arm will be the Urotronic Optilume Drug Coated Balloon (DCB).
Device: Optilume Drug Coated Balloon (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.

Active Comparator: Control Treatment
The control arm will be treated by a urethral dilation method considered to be best standard of care for the study site and subject. A control treatment may be either a rod, uncoated balloon or DVIU.
Device: Control Treatment
A control subject may be dilated with either a rod, uncoated balloon or DVIU until the desired result is reached, based on standard of care for the clinical site and treating physician
Other Names:
  • Uncoated dilation balloon
  • Direct Vision Internal Urethrotomy (DVIU)
  • Rigid Rod




Primary Outcome Measures :
  1. Efficacy: Stricture Free Rate [ Time Frame: 6 months ]
    Stricture Free Rate

  2. Safety: Rate of Major Device or Procedure Related complications [ Time Frame: 3 months ]
    Rate of Major Device or Procedure Related complications


Secondary Outcome Measures :
  1. Change in Qmax (Peak Flow Rate) [ Time Frame: 6 months ]
    Change in Qmax (Peak Flow Rate) as measured by uroflowmetry

  2. IPSS Percent Responder [ Time Frame: 12 months ]
    IPSS Percent Responder (50% improvement in IPSS score or IPSS score of 11 or lower)

  3. Time to Treatment Failure [ Time Frame: 5 years ]
    Time until additional stricture treatment is required, if applicable



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, tandem or diffuse anterior urethral stricture(s), less than or equal to 3.0 cm total length measured by retrograde urethrogram. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture).
  4. Two or more prior dilation treatments of the same stricture, 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 urinary tract infections (UTI's).
  6. International Prostrate Symptoms Score (IPSS) score of 11 or higher (assumed to be "35" if suprapubic catheter is present)
  7. Lumen diameter ≤ 12F by urethrogram
  8. Qmax <15 ml/sec (assumed to be "0" if suprapubic catheter is present)
  9. Guidewire must be able to cross the lesion

Exclusion Criteria:

  1. Subjects with diffuse stricture length, greater than 3.0 cm in total length. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture).
  2. Subjects with a history of hypersensitivity reactions to TAXOL, on medication that may have negative interaction with paclitaxel, with solid tumors who have a baseline neutrophil counts of <1500 cells/mm3 or subjects with AIDS-related Kaposi's sarcoma with baseline neutrophile counts of <1000 cells/mm3.
  3. Subjects who had an indwelling suprapubic catheter longer than three (3) months total prior to enrollment.
  4. Previous urethroplasty within the anterior urethra
  5. Stricture dilated or incised within the last six (6) weeks (urethral catheterization is not considered dilation)
  6. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.
  7. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician
  8. Diagnosis of untreated and unresolved BPH or BNC
  9. Untreated stress urinary incontinence (SUI).
  10. History of diagnosed radiation cystitis.
  11. Diagnosis of carcinoma of the urethra, bladder or prostate within the last five (5) years
  12. Active kidney, bladder, urethral or ureteral stone passage in the last six (6) weeks or concern of stone passage in the next 6 weeks at the discretion of the investigator.
  13. Diagnosis of chronic renal failure and treatment with hemodialysis
  14. New diagnosis of OAB (overactive bladder) within the last six (6) months
  15. 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.)
  16. Dependence on Botox (onabotulinumtoxinA) in urinary system
  17. Presence of an artificial urinary sphincter, slings, or stent(s) in the urethra or prostate
  18. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
  19. Diagnosed with Lichen Sclerosus, or stricture due to balanitis xerotica obliterans (BXO)
  20. Previous hypospadias repair
  21. History of cancer in non-genitourinary system which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five (5) years of enrollment
  22. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires
  23. Unwilling to use protected sex for thirty (30) days' post treatment
  24. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential.
  25. Inability to provide Informed Consent Form (ICF) and/or comply with all the required follow-up requirements
  26. Participation in other pre-market studies or treatment with an investigational drug or device. Long term follow up or post market study of an approved device is allowed.
  27. Current active infection in the urinary system
  28. Current uncontrolled diabetes (hemoglobin A1c > 8.0%) or evidence of poor wound healing due to diabetes
  29. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function.
  30. Visible hematuria in subject's urine sample without known contributing factor
  31. Invisible hematuria (or significant microscopic hematuria, i.e. hematuria of ≥ 3 RBC's/HPF) that may be caused by a clinically significant disease unless it is attributed to the urethral stricture disease or other causes which are benign and not requiring treatment.

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): NCT03499964


Contacts
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Contact: Laura Moffett 763-285-7489 moffettl@urotronic.com
Contact: Camille Sanchez camille.sanchez@clinlogix.com

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Sponsors and Collaborators
Urotronic Inc.
ClinLogix. LLC
Investigators
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Principal Investigator: Sean Elliott, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Ramon Virasoro, MD Urology of Virginia

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Responsible Party: Urotronic Inc.
ClinicalTrials.gov Identifier: NCT03499964     History of Changes
Other Study ID Numbers: PR1076
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Urotronic Inc.:
pivotal trial
randomized
lower urinary tract symptoms (LUTS)
urethral stricture
obstruction
Additional relevant MeSH terms:
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Urethral Stricture
Constriction, Pathologic
Pathological Conditions, Anatomical
Urethral Obstruction
Urethral Diseases
Urologic Diseases