Pathway CH-1 Long-Term Follow-Up
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Autonomic Technologies, Inc.
First received: June 7, 2012
Last updated: June 29, 2015
Last verified: December 2014
The objective of the study is to demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in cluster headache subjects.
||Observational Model: Cohort
Time Perspective: Prospective
||Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache
Primary Outcome Measures:
- Demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for the stimulation of the SPG in CH Subjects. [ Time Frame: Long-Term ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2015 (Final data collection date for primary outcome measure)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects who have been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial, who have completed the Pathway CH-1 trial, and who remain implanted with an ATI Neurostimulator.
- Subject has been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial.
- Subject has completed the Pathway CH-1 Open Label Final office visit and remains implanted with an ATI Neurostimulator.
- Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
- Subject is able to provide written informed consent prior to participation in the study.
- Subject has or requires a pacemaker/defibrillator or other implantable device having a sense amplifier that is programmed 'On.'
- Subject is not suitable for the study for any reason in the judgment of the Investigator.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616511
|Headache Research Unit. University Department of Neurology, Citadelle Hospital
|Liege, Belgium, B-4000 |
|Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen
|Glostrup, Copenhagen, Denmark, DK-2600 |
|Headache Center, Dept. of Neurology, University Duisburg-Essen
|Essen, Germany, 45147 |
|Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
|Hamburg, Germany, 20246 |
|Servicio de Neurologia, Hospital Clinico Universitario
|Valencia, Spain, 46010 |
Autonomic Technologies, Inc.
||Jean Schoenen, MD, PhD
No publications provided
||Autonomic Technologies, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 7, 2012
||June 29, 2015
||Belgium: Federal Agency for Medicinal Products and Health Products
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 30, 2015
Central Nervous System Diseases
Headache Disorders, Primary
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias