Back to resultsAcute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
AHLeveeS System
Sponsored by
About this trial
This is an interventional device feasibility trial for Overactive Bladder
Eligibility Criteria
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
Sites / Locations
- Maastricht University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational SNS device
Arm Description
Outcomes
Primary Outcome Measures
Sacral Nerve Response measured by observed bellow response and big toe flexion
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03643380
Brief Title
Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
Official Title
Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 17, 2017 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
January 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuspera Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational SNS device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AHLeveeS System
Intervention Description
AHLeveeS System for treatment of overactive bladder
Primary Outcome Measure Information:
Title
Sacral Nerve Response measured by observed bellow response and big toe flexion
Description
Stimulation of the S3 sacral nerve measured by observed bellows response and big toe flexion
Time Frame
Procedure
Title
AHLeveeS System placement in the S3 foramen assessed by fluoroscopy image
Description
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
Time Frame
Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gommert A. van Koeveringe
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
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