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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ROBUST-LT Post-Approval Study (PR1277)


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General
Study Status Study Pending
Application Number /
Requirement Number
P210020 / PAS001
Date Original Protocol Accepted 01/19/2022
Date Current Protocol Accepted  
Study Name ROBUST-LT Post-Approval Study (PR1277)
Device Name Optilume Urethral Drug Coated Balloon
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The ROBUST-LT PAS is a continuation of the ROBUST clinical program (ROBUST I, II and III clinical studies). ROBUST-LT is designed to verify the continued safety and effectiveness for the Optilume Urethral Drug-Coated Balloon (DCB). It is intended to assess durability of outcomes after 1 year follow-up of the 194 patients currently enrolled in the ROBUST clinical program. Each patient’s follow-up will be continued out to 5 years post-treatment.

The harmonized primary effectiveness endpoint is defined as a patient experiencing a =30% improvement in International Prostate Symptom Score (IPSS) from baseline without the need for additional intervention. Additional harmonized endpoints include freedom from repeat intervention, uroflowmetry, IPSS, adverse event summary, and International Index of Erectile Function (IIEF). The primary safety endpoint is mortality rate that will be calculated for each study and reported as the number of deaths per 100 patient years. All adverse event (AE) data will be collected. Progress reports will be submitted to the FDA annually after PMA approval.
Study Population ROBUST I: Adult men 18 years of age or older with anterior urethral stricture = 2 cm in length and with = 1 prior dilation.

ROBUST II: Adult men 18 years of age or older with anterior urethral strictures = 3 cm in length and with = 2 prior dilations.

ROBUST III: Adult men 18 years of age or older with with anterior urethral strictures = 3 cm in length in subjects with = 2 prior dilations
Sample Size No. of subjects: 194 subjects
No assumptions for sample size estimation. Enrollment is complete.
No. of sites: ROBUST I (4 sites), ROBUST II (5 sites), ROBUST III (22 sites).
Sites location: US and the following countries: ROBUST I (Panama and Dominican Republic), ROBUST II (U.S.), ROBUST III (U.S. and Canada).
Key Study Endpoints Safety Endpoints
Primary: The mortality rate that will be calculated for each study and reported as the number of deaths per 100 patient years.
Secondary: Frequency and severity of adverse events, erectile function (EF), orgasmic function (OF), and overall satisfaction IIEF subdomains.

Effectiveness Endpoints
Primary: Responder rate: A patient experiencing a =30% improvement in International Prostate Symptom Score (IPSS) from baseline without the need for additional intervention.
Secondary: Additional harmonized endpoints include freedom from repeat intervention, uroflowmetry (Qmax and PVR), IPSS, adverse event summary, and International Index of Erectile Function (IIEF).
Follow-up Visits and Length of Follow-up Each subject will be followed annually for 5 years with assessments as described in the Study Endpoints section, above.


ROBUST-LT Post-Approval Study (PR1277) Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 12/03/2022    
2 year report 12/03/2023    
3 year report 12/02/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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