NL-OMON44588
Completed
N/A
Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans with Urinary Incontinence - NSM-001
euSpera Medical Inc.0 sites10 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- overactive bladder syndrome
- Sponsor
- euSpera Medical Inc.
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient must be eligible for treatment and indicated for the Medtronic InterStim® system or InterStim® II (implantable pulse generator and lead).
- •Patient wishes to undergo an InterStim® or InterStim® II implant procedure after this acute study.
- •Patient must be in good general health in the opinion of the Investigator.
- •Patient is able to understand and has voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study\-specific procedures.
- •Patient must be minimum 18 years and maximum 65 years of age.
Exclusion Criteria
- •Patient has any of the contraindications for the InterStim® system or InterStim® II system:
- •o Previous sacral surgery
- •o Neurological conditions
- •o Neurogenic bladder
- •o Neurogenic detrusor over activity
- •o Multiple Sclerosis
- •o Spinal cord injury
- •o Stress urinary incontinence
- •o Primary pelvic pain
- •o Pregnant as determined by urine pregnancy test during screening on the day of the procedure or plan to become pregnant
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary IncontinenceOveractive BladderNCT03643380Neuspera Medical, Inc.6
Not Yet Recruiting
N/A
Research of the utility of newly developed implant system (Octafix)JPRN-UMIN000006183Department of Dentistry and Oral Surgery,Shinsyu University School of Medicine50
Withdrawn
N/A
Study of a novel implantable device to generate an autologous vascular graft for hemodialysis accessAVFHemodialysis access10003184NL-OMON51014VACIS B.V.20
Completed
N/A
Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular DysfunctionCoronary Microvascular DysfunctionNCT04523168Amir Lerman30
Completed
N/A
An early clinical feasibility study of a new prosthesis: the NewBreez® Intralaryngeal device; a possible solution for severe aspiration in head and neck cancer patientsaspirationDysfunctional larynxswallowing impairment10027656NL-OMON42228Antoni van Leeuwenhoek Ziekenhuis5