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Clinical Trial

INOPASE - Performance and Safety Study of a Personalised SNM System

NCT: NCT07193407 · RECRUITING

NCT IDNCT07193407
StatusRECRUITING
Start Date2026-02-27
Completion2026-12-31

Brief Summary

The goal of this clinical trial is to learn whether a new sacral neuromodulation (SNM) system (INO-SNM-01) can safely and effectively sense bladder nerve activity and provide stimulation to help manage symptoms of refractory overactive bladder in adult women aged 18-70 who have not responded to standard treatments. The main questions it aims to answer are: * Is there a clear relationship between bladder nerve activity and patient-reported urgency sensations? * Can targeted stimulation based on bladder nerve activity reduce overactive bladder symptoms? * Is the INO-SNM-01 System safe to use? Researchers will not use a comparison group in this study. Instead, all participants will receive the investigational device to see if it works as intended. Participants will undergo surgery to have a temporary trial lead implanted near the sacral nerve and spend up to 2 days in hospital for monitoring and testing to assess the device sensing and stimulation capabilities. Up to 10 participants will take part in this first-in-human feasibility study at a single site in Australia.

Frequently Asked Questions

What is INOPASE - Performance and Safety Study of a Personalised SNM System?

INOPASE - Performance and Safety Study of a Personalised SNM System is a clinical trial registered under NCT07193407. Current status: RECRUITING.

What is the status of NCT07193407?

The current status of NCT07193407 (INOPASE - Performance and Safety Study of a Personalised SNM System) is: RECRUITING.

When did INOPASE - Performance and Safety Study of a Personalised SNM System start?

INOPASE - Performance and Safety Study of a Personalised SNM System started on 2026-02-27.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.