Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
NCT ID: NCT03643380
Last Updated: 2018-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2017-08-17
2018-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Investigational SNS device
AHLeveeS System
AHLeveeS System for treatment of overactive bladder
Interventions
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AHLeveeS System
AHLeveeS System for treatment of overactive bladder
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Neuspera Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gommert A. van Koeveringe
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
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Maastricht University
Maastricht, , Netherlands
Countries
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Other Identifiers
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NSM-001
Identifier Type: -
Identifier Source: org_study_id
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