Pathway CH-1 Long-Term Follow-Up

Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01616511

Enrollment

Registered

2012-06-11

Start date

2012-06-30

Completion date

2016-06-30

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Cluster Headache

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for the stimulation of the SPG in CH Subjects.	Long-Term

Countries

Belgium, Denmark, Spain

Outcome results