Pathway CH S&E Registry

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02440776

Acronym

SER

Enrollment

Registered

2015-05-12

Start date

2015-04-30

Completion date

2018-06-30

Last updated

2018-06-26

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

Conditions

Cluster Headache

Brief summary

Monitor the safety and performance of the Pulsante Microstimulator System.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Characterization of all device/procedure related Adverse Events	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

Measure	Time frame	Description
Acute response to therapy	Through five years post implant	Outcome will be assessed at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.

Countries

Denmark, Germany, Sweden, Switzerland, United Kingdom

Outcome results