Overactive BladderPhase 1NCT03643380
Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
A Phase 1 study testing AHLeveeS System in people with Overactive Bladder, run by Neuspera Medical, Inc. at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- AHLeveeS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Aug 2017to 30 Jan 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subject had any of the contraindications for the InterStim system or InterStim II system
Trial locations and contacts
1 site in 1 country.
About this study
A pre-market, prospective, non-randomized acute feasibility study for the treatment of patients with urinary incontinence (UI) as a consequence of urinary incontinence.
- Conditions
- Overactive Bladder
- Being tested
- AHLeveeS System
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHLeveeS SystemDevice
AHLeveeS System for treatment of overactive bladder
| Study group | Role | What they receive |
|---|---|---|
| Investigational SNS device | Experimental | Not described Receives: Device: AHLeveeS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Procedure
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
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start17 Aug 2017
- Primary completion15 Nov 2017
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuspera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gommert A. van Koeveringe, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643380
- Sponsor's protocol ID
- NSM-001
- Status last verified
- Aug 2018
- First submitted
- 13 Jul 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03643380
- Acronym / sponsor ID
- NSM-001
- Conditions
- Overactive Bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Neuspera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pre-market, prospective, non-randomized acute feasibility study for the treatment of patients with urinary incontinence (UI) as a consequence of urinary incontinence.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational SNS device | Experimental | Device: AHLeveeS System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Subject had any of the contraindications for the InterStim system or InterStim II system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AHLeveeS SystemAHLeveeS System for treatment of overactive bladder | Device | Investigational SNS device |
Primary outcome
Sacral Nerve Response measured by observed bellow response and big toe flexion
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gommert A. van Koeveringe principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AHLeveeS System in people with Overactive Bladder, run by Neuspera Medical, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sacral Nerve Response measured by observed bellow response and big toe flexion (time frame: Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.