Pathway CH-1 Long-Term Follow-Up

January 5, 2017 updated by: Autonomic Technologies, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liege, Belgium, B-4000
        • Headache Research Unit. University Department of Neurology, Citadelle Hospital
  • Denmark
      • Glostrup, Copenhagen, Denmark, DK-2600
        • Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen
  • Spain
      • Valencia, Spain, 46010
        • Servicio de Neurologia, Hospital Clinico Universitario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pathway CH-1 Subjects

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Long-Term
Long-Term

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Autonomic Technologies, Inc.

Investigators

  • Principal Investigator: Jean Schoenen, MD, PhD, Citadelle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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