Pathway CH-1 Long-Term Follow-Up

Autonomic Technologies

Status: Completed

Conditions: Chronic Cluster Headache

Study type: Observational

Funder types: Industry

Identifiers

NCT01616511

CP-005

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Volunteers: No 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.

Trial design

33 participants in 1 patient group

Pathway CH-1 Subjects