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Pathway CH S&E Registry (SER)

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ClinicalTrials.gov Identifier: NCT02440776
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Autonomic Technologies, Inc.

Brief Summary:
Monitor the safety and performance of the Pulsante Microstimulator System.

Condition or disease
Cluster Headache

Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: 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
Study Start Date : April 2015
Actual Primary Completion Date : May 13, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who meet the CE marked labeling for cluster headache for the Pulsante Microstimulator System
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440776


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

Responsible Party: Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02440776     History of Changes
Other Study ID Numbers: CP-010
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Headache
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases