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BlueWind RENOVA iStim™ System for the Treatment of OAB (OASIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03596671
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : January 3, 2024
Sponsor:
Information provided by (Responsible Party):
BlueWind Medical

Tracking Information
First Submitted Date  ICMJE July 1, 2018
First Posted Date  ICMJE July 24, 2018
Last Update Posted Date January 3, 2024
Actual Study Start Date  ICMJE June 12, 2019
Actual Primary Completion Date October 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Improvement in urinary urgency incontinence (UUI) episodes based on patient voiding diary [ Time Frame: 6 months ]
  • Safety - incidence of adverse events [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BlueWind RENOVA iStim™ System for the Treatment of OAB
Official Title  ICMJE A Prospective Study to Assess the Efficacy and Safety of the BlueWind RENOVA iStim™ System in the Treatment of Patients Diagnosed With Overactive Bladder (OASIS - OverActive Bladder StImulation System Study)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Treatment of Patients Suffering From Overactive Bladder (OAB)
Intervention  ICMJE Device: RENOVA iStim™ System
Tibial implantable neuromodulation device
Study Arms  ICMJE Experimental: Treatment arm
RENOVA iStim™ System implanted patients
Intervention: Device: RENOVA iStim™ System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2018)		 200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Actual Primary Completion Date October 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female aged 18 or greater (21 in the US)
  • More than or equal to 6 months history of UUI diagnosis
  • Patient who is mentally competent with the ability to understand and comply with the requirements of the study

Exclusion Criteria:

  • Any significant medical condition that is likely to interfere with study procedures
  • Patients who are breastfeeding
  • Predominant stress incontinence
  • Have a life expectancy of less than 1 year
  • Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roni Diaz (469) 423 -2015 roni.diaz@bluewindmedical.com
Listed Location Countries  ICMJE Belgium,   Netherlands,   United Kingdom,   United States
Removed Location Countries Germany,   Israel
 
Administrative Information
NCT Number  ICMJE NCT03596671
Other Study ID Numbers  ICMJE G02-CLP-0002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party BlueWind Medical
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BlueWind Medical
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Heesakkers, MD Maastricht University Medical Centre
PRS Account BlueWind Medical
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP