Acute Study to Evaluate a Novel Implantable Midfield Powe... | NCT03643380

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

NCT03643380

Sponsor

Neuspera Medical, Inc.

Status

Completed

Last Update Posted

Aug 22, 2018Actual

Enrollment

6Actual

Phase

Phase 1

Conditions

Overactive Bladder

Interventions

AHLeveeS System

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 17, 2017Actual

Primary Completion Date

Nov 15, 2017Actual

Completion Date

Jan 30, 2018Actual

First Submitted Date

Jul 13, 2018

First Submission Date that Met QC Criteria

Aug 20, 2018

First Posted Date

Aug 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2018

Last Update Posted Date

Aug 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigational SNS device	Experimental		Device: AHLeveeS System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AHLeveeS System	Device	AHLeveeS System for treatment of overactive bladder	Investigational SNS device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	Procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gommert A. van Koeveringe	Maastricht University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University		Maastricht		6202 AZ	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided