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NCT03596671 · ClinicalTrials.gov registry record · NA

BlueWind RENOVA iStim™ System for the Treatment of OAB

A NA study, sponsored by BlueWind Medical.

Completed
Registry status
NA
Development phase
282
Enrollment target

NCT03596671: Completed NA study, sponsored by BlueWind Medical.

NCT03596671 is a NA study that has completed, run by BlueWind Medical. The registered enrollment target is 282 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03596671, a NA study, has completed, sponsored by BlueWind Medical.

COMPLETED
Registry status
NA
Development phase
282 participants
Enrollment target

Study Summary

The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStim™ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.

Primary Outcome

Proportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in average number of urgency related incontinence episodes, measured by 7-day Patient Voiding Diary.

Interventions

  • DEVICE RENOVA iStim™ System

Trial Details

FieldValue
Enrollment Target 282 participants
Start Date 2019-06-12
Est. Completion 2025-01-24
Phase NA
BlueWind Medical

2 total trials

What the finished NCT03596671 record still lists

NCT03596671 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which RENOVA iStim™ System is the first listed.

NCT03596671 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03596671 about?

NCT03596671 is a clinical study titled "BlueWind RENOVA iStim™ System for the Treatment of OAB". The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStim™ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.

What is the current status of trial NCT03596671?

This trial is currently completed. It is a NA study. The enrollment target is 282 participants. The study started on 2019-06-12. Estimated completion is 2025-01-24.

What interventions are being tested in trial NCT03596671?

The interventions under investigation include: RENOVA iStim™ System (DEVICE).

Who is sponsoring clinical trial NCT03596671?

This trial is sponsored by BlueWind Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03596671's enrollment target sits among peer trials

282 379th of 2000 higher than 1,621 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03596671, the US trial registry maintained by the National Library of Medicine. NCT03596671 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.