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ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

NCT03014726 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2024-03-22

Study results available
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Summary

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

Conditions

  • Stricture Urethra

Interventions

COMBINATION_PRODUCT

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.

Sponsors & Collaborators

  • Urotronic Inc.

    lead INDUSTRY

Principal Investigators

  • Ian Schorn · Urotronic (Study Sponsor)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-10-31
Completion
2023-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03014726 on ClinicalTrials.gov