Pathway CH S&E Registry

NCT ID: NCT02440776

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-06-30

Brief Summary

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Monitor the safety and performance of the Pulsante Microstimulator System.

Detailed Description

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Conditions

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Cluster Headache

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Autonomic Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rigshospitalet Neurocenter

Glostrup Municipality, , Denmark

Site Status

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie

Dresden, , Germany

Site Status

Heinrich-Heine-University

Düsseldorf, , Germany

Site Status

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Site Status

Klinik für Schmerztherapie, Rotes Kreuz Krankenhaus, Hansteinstr. 29

Kassel, , Germany

Site Status

Neurologie + Kopfschmerzzentrum Münchner Freiheit

Munich, , Germany

Site Status

Neurologiska Kliniken-Karolinska UniversitetssjukhusetSolna

Stockholm, , Sweden

Site Status

University Hospital Zurich, Klinik f. Neurologie, Frauenklinikstr. 26

Zurich, , Switzerland

Site Status

The Walton Center

Liverpool, , United Kingdom

Site Status

Countries

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Denmark Germany Sweden Switzerland United Kingdom

Other Identifiers

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CP-010

Identifier Type: -

Identifier Source: org_study_id

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