Pathway CH S&E Registry

Cluster Headache Clinical Trial

— SER  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02440776
• Other study ID #: CP-010
• Status: Active, not recruiting
• Start date: April 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2018
• Source: Autonomic Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Monitor the safety and performance of the Pulsante Microstimulator System.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 30, 2018
• Est. primary completion date: May 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Locations

Country	Name	City	State
Denmark	Rigshospitalet Neurocenter	Glostrup
Germany	Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie	Dresden
Germany	Heinrich-Heine-University	Düsseldorf
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Klinik für Schmerztherapie, Rotes Kreuz Krankenhaus, Hansteinstr. 29	Kassel
Germany	Neurologie + Kopfschmerzzentrum Münchner Freiheit	Munich
Sweden	Neurologiska Kliniken-Karolinska UniversitetssjukhusetSolna	Stockholm
Switzerland	University Hospital Zurich, Klinik f. Neurologie, Frauenklinikstr. 26	Zurich
United Kingdom	The Walton Center	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Autonomic Technologies, Inc.

Countries where clinical trial is conducted

Denmark,  Germany,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of all device/procedure related Adverse Events	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	Acute response to therapy	Outcome will be assessed at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.	Through five years post implant