Pathway CH S&E Registry (SER)

June 25, 2018 updated by: Autonomic Technologies, Inc.

Pathway CH S&E Registry: Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache - ATI Neurostimulation System is Branded Internationally as Pulsante™ Microstimulator System

Monitor the safety and performance of the Pulsante Microstimulator System.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

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

  • Denmark
      • Glostrup, Denmark, 2600
        • Rigshospitalet Neurocenter
  • Germany
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie
      • Düsseldorf, Germany, D-40225
        • Heinrich-Heine-University
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Kassel, Germany, 34121
        • Klinik für Schmerztherapie, Rotes Kreuz Krankenhaus, Hansteinstr. 29
      • Munich, Germany, 80802
        • Neurologie + Kopfschmerzzentrum Münchner Freiheit
  • Sweden
      • Stockholm, Sweden, 17176
        • Neurologiska Kliniken-Karolinska UniversitetssjukhusetSolna
  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich, Klinik f. Neurologie, Frauenklinikstr. 26
  • United Kingdom
      • Liverpool, United Kingdom, L97LJ
        • The Walton Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who meet the CE marked labeling for cluster headache for the Pulsante Microstimulator System

Description

Inclusion Criteria:

  1. Patient meets CE marked labeling for cluster headache.
  2. Patient has the ability to read, comprehend and reliably record information as required by the Protocol.
  3. Patient is able to provide written informed consent prior to participation in the study.

Exclusion Criteria:

1. Patient has other significant pain problem that might confound the study assessments in the opinion of the Investigator.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of all device/procedure related Adverse Events
Time Frame: Through five years post implant
Outcome will be assessed at Implant, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.
Through five years post implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute response to therapy
Time Frame: Through five years post implant
Outcome will be assessed at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.
Through five years post implant

Collaborators and Investigators

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

Sponsor

Autonomic Technologies, Inc.

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

April 1, 2015

Primary Completion (Actual)

May 13, 2018

Study Completion (Anticipated)

June 30, 2018

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-010

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.

Clinical Trials on Cluster Headache

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe