Our clinical program is designed to generate high-quality evidence supporting the safety and efficacy of Uroplug for regulatory clearance and clinical adoption.
Our pivotal clinical study is a prospective, double-blind, randomized, sham-controlled trial designed in consultation with leading clinical investigators and regulatory experts. The study protocol has been developed to support a De Novo or 510(k) submission to the FDA.
The trial evaluates both the therapeutic efficacy and safety of the Uroplug device across a diverse patient population with confirmed diagnosis of the target chronic condition.
Statistically significant reduction in [condition-specific validated symptom score] at [X] weeks vs. sham control, measured by [validated instrument].
Patient-reported quality of life improvement (via [PRO instrument]), device safety profile, treatment adherence rates, and durability of response at extended follow-up.
Completed in-vitro and ex-vivo studies confirming mechanism of action. Biocompatibility and electrical safety testing per ISO 10993 and IEC 60601.
Open-label feasibility study to confirm safety and initial efficacy signals in a small patient cohort. [Planned / In Progress / Complete]
Double-blind, sham-controlled, multi-site pivotal trial. Designed to meet FDA evidentiary requirements for [De Novo / 510(k)] clearance.
Submission of regulatory dossier. Anticipated timeline for clearance and initial commercial launch. [Target Year TBD]
Early-stage data from preclinical and feasibility studies. Full results pending completion of the pivotal trial program.
Preliminary data are not indicative of final clinical results. Enrollment status and data availability are subject to change. This section will be updated as data become available.
Uroplug is pursuing a [De Novo / 510(k)] regulatory pathway with the FDA. Our regulatory strategy has been informed by pre-submission meetings and consultation with experienced regulatory counsel.
We are also evaluating CE marking for EU market access and pursuing alignment with international standards (IEC 60601, ISO 13485, ISO 14971).
We welcome inquiries from investigators, clinical sites, and KOLs interested in our research program.
Contact Clinical Team