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 : Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : June 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urethral Stricture||Device: Optilume Drug Coated Balloon (DCB) Device: Control Treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Parallel Assignment|
|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 :||December 2020|
|Estimated Study Completion Date :||June 2025|
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
- Efficacy: Stricture Free Rate [ Time Frame: 6 months ]Stricture Free Rate
- Safety: Rate of Major Device or Procedure Related complications [ Time Frame: 3 months ]Rate of Major Device or Procedure Related complications
- Change in Qmax (Peak Flow Rate) [ Time Frame: 6 months ]Change in Qmax (Peak Flow Rate) as measured by uroflowmetry
- IPSS Percent Responder [ Time Frame: 12 months ]IPSS Percent Responder (50% improvement in IPSS score or IPSS score of 11 or lower)
- Time to Treatment Failure [ Time Frame: 5 years ]Time until additional stricture treatment is required, if applicable
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
|Principal Investigator:||Sean Elliott, MD||University of Minnesota|
|Principal Investigator:||Ramon Virasoro, MD||Urology of Virginia|