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

August 20, 2018 updated by: Neuspera Medical, Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Investigational SNS device
Device: AHLeveeS System
AHLeveeS System for treatment of overactive bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Procedure
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
Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuspera Medical, Inc.

Investigators

  • Principal Investigator: Gommert A. van Koeveringe, Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 17, 2017

Primary Completion (ACTUAL)

November 15, 2017

Study Completion (ACTUAL)

January 30, 2018

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (ACTUAL)

August 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSM-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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