Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence

NCT03643380 — Phase 1, Completed, 6 participants, Neuspera Medical, Inc.

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Registry	NCT03643380
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, device feasibility
Enrollment	6 (Actual)
Sponsor	Neuspera Medical, Inc. (Industry)
Conditions	Overactive Bladder
Interventions	AHLeveeS System (Device)
Dates	start 2017-08-17, primary completion 2017-11-15, completion 2018-01-30, first posted 2018-08-22, last updated 2018-08-22
Locations	1 site in Netherlands

-Summary

A pre-market, prospective, non-randomized acute feasibility study for the treatment of patients with urinary incontinence (UI) as a consequence of urinary incontinence.

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+Arms and interventions

Arm	Type	Interventions	Description
Investigational SNS device	Experimental	Device: AHLeveeS System

AHLeveeS System (Device): AHLeveeS System for treatment of overactive bladder

+Outcome measures

Primary outcomes

Sacral Nerve Response measured by observed bellow response and big toe flexion [Procedure]: Stimulation of the S3 sacral nerve measured by observed bellows response and big toe flexion
AHLeveeS System placement in the S3 foramen assessed by fluoroscopy image [Procedure]: Confirm that the AHLeveeS System can be correctly placed and inserted in close proximity of the sacral nerve in the S3 foramina assessed by fluoroscopy image

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Subject was eligible for treatment and indication for the Medtronic InterStim system or InterStim II
* Subject wished to undergo an InterStim or InterStim II implant procedure after this acute clinical investigation
* Subject was in good health in the opinion of the investigator
* Subject was able to understand and voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures
* Subject was minimum of 18 years and maximum of 65 years of age

Exclusion Criteria:

\- Subject had any of the contraindications for the InterStim system or InterStim II system

+Locations (1)

Facility	City	Country	Status
Maastricht University	Maastricht	Netherlands

+Investigators

Gommert A. van Koeveringe, Principal investigator, Maastricht University

My Notes

Public

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