Pathway CH-1 Long-Term Follow-Up | NCT01616511

Studies
Pathway CH-1 Long-Term Follow-Up

NCT01616511

Sponsor

Autonomic Technologies, Inc.

Status

Completed

Last Update Posted

Jan 9, 2017Estimated

Enrollment

33Actual

Phase

Not provided

Conditions

Chronic Cluster Headache

Interventions

Not provided

Countries

Belgium
Denmark
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Jun 7, 2012

First Submission Date that Met QC Criteria

Jun 7, 2012

First Posted Date

Jun 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2017

Last Update Posted Date

Jan 9, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Label	Type	Description	Intervention Names
Pathway CH-1 Subjects

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean Schoenen, MD, PhD	Citadelle Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Headache Research Unit. University Department of Neurology, Citadelle Hospital		Liège		B-4000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D003027	Cluster Headache

Ancestor Terms

ID	Term
D051303	Trigeminal Autonomic Cephalalgias
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided