Pathway CH-1 Long-Term Follow-Up

NCT ID: NCT01616511

Last Updated: 2017-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Cluster Headache

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pathway CH-1 Subjects

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Autonomic Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Schoenen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Citadelle Hospital

Locations

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Headache Research Unit. University Department of Neurology, Citadelle Hospital

Liège, , Belgium

Site Status

Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen

Glostrup, Copenhagen, Denmark, Denmark

Site Status

Servicio de Neurologia, Hospital Clinico Universitario

Valencia, Spain, Spain

Site Status

Countries

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Belgium Denmark Spain

Other Identifiers

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CP-005

Identifier Type: -

Identifier Source: org_study_id

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