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Pathway CH S&E Registry (SER)

This study is currently recruiting participants.
Verified October 2017 by Autonomic Technologies, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02440776
First Posted: May 12, 2015
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Autonomic Technologies, Inc.
  Purpose
Monitor the safety and performance of the Pulsante Microstimulator System.

Condition
Cluster Headache

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Autonomic Technologies, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 30
Study Start Date: April 2015
Estimated Study Completion Date: May 2023
Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

  Contacts and Locations
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


Contacts
Contact: Carla Griffin 650-395-4229 cgriffin@ati-spg.com
Contact: Jurgen Hambitzer Hhambitzer@ati-spg.com

Locations
Denmark
Rigshospitalet Neurocenter Recruiting
Glostrup, Denmark, 2600
Contact: Rigmor Jensen, Dr. med    +45 38632062    RIGJ@glo.regionh.dk   
Contact: Nunu Lund, Dr.    +45 38632062    nunu.laura.timotheussen.lund.01@regionh.dk   
Principal Investigator: Rigmor Jensen, Dr. med         
Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie Recruiting
Dresden, Germany, 01307
Contact: Gudrun Goßrau, PD Dr. med    +49 0351-458-2063    Gudrun.Gossrau2@uniklinikum-dresden.de   
Principal Investigator: Gudrun Goßrau, PD Dr. med         
Heinrich-Heine-University Recruiting
Düsseldorf, Germany, D-40225
Contact: Jan Vesper, Prof. Dr. med.    49 211 81 16058    jan.vesper@uniklinik-duesseldorf.de   
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Peter Behrens, Dr. med    0761/270-50010    peter.behrens@uniklinik-freiburg.de   
Klinik für Schmerztherapie, Rotes Kreuz Krankenhaus, Hansteinstr. 29 Recruiting
Kassel, Germany, 34121
Contact: Andreas Boger, Dr. med    +43 0561/3086 4601    boeger@rkh-kassel.de   
Contact: Stephanie Schulze    +49 0561/3086 74183    Stephanie.schulze@rkh-kassel.de   
Principal Investigator: Andreas Boger, Dr. med         
Neurologie + Kopfschmerzzentrum Münchner Freiheit Recruiting
Munich, Germany, 80802
Contact: Margarete Siemen, Dr. med    +49 (0)89 / 389977-15    info2@neuro-one.de   
Principal Investigator: Holger Kaube, Dr. med         
Sub-Investigator: Margarete Siemen, Dr. med         
Sweden
Neurologiska Kliniken-Karolinska UniversitetssjukhusetSolna Recruiting
Stockholm, Sweden, 17176
Contact: Anna Steinberg, MD    08-517 753 18    anna.steinberg@karolinska.se   
Contact: Hans Ericson, MD    0733-687799    hans.ericson@akademiska.se   
Switzerland
University Hospital Zurich, Klinik f. Neurologie, Frauenklinikstr. 26 Recruiting
Zurich, Switzerland, 8091
Contact: Jens Petersen, Dr. med    +41 44 255 1111    jens.petersen@usz.ch   
United Kingdom
The Walton Center Recruiting
Liverpool, United Kingdom, L97LJ
Contact: Nick Silver, Dr    +44 1515253611    nicholas.silver@thewaltoncentre.nhs.uk   
Contact: Paul Eldridge, Prof    +44 1515253611    paul.eldridge@thewaltoncentre.nhs.uk   
Principal Investigator: Nick Silver, Dr         
Sponsors and Collaborators
Autonomic Technologies, Inc.
  More Information

Responsible Party: Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02440776     History of Changes
Other Study ID Numbers: CP-010
First Submitted: May 6, 2015
First Posted: May 12, 2015
Last Update Posted: November 2, 2017
Last Verified: October 2017

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