XLTCS - Accelerometer Data Collection in an Epilepsy Moni... | NCT04282681

Studies
XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU)

NCT04282681

Sponsor

LivaNova

Status

Withdrawn

Last Update Posted

Aug 25, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Epilepsy, Tonic-Clonic

Interventions

Accelerometer Live-Streaming Tool

Countries

Belgium

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision due to clinical strategy changes

Expanded Access Info

Start Date

Mar 16, 2020Estimated

Primary Completion Date

Aug 28, 2021Estimated

Completion Date

Feb 28, 2022Estimated

First Submitted Date

Feb 21, 2020

First Submission Date that Met QC Criteria

Feb 21, 2020

First Posted Date

Feb 25, 2020Actual

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

Aug 24, 2020

Last Update Posted Date

Aug 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 primary objective of this study is to collect accelerometer data from subjects monitored in an EMU with concurrent video EEG.

Detailed Description

XLTCS (LNE-800) is an international multicenter prospective data collection study to gather accelerometer data. The population under the study comprises patients monitored in an Epilepsy Monitoring Unit (EMU) with concurrent video EEG and who are expected to have at least one seizure with tonic-clonic convulsive movement.

A maximum of one hundred and fifty (150) patients will be enrolled and will wear an accelerometer, and up to 6 sites may participate in this study. The total enrollment period will take approximately 2 years.

Once the accelerometer was adhered to the subject, subjects will be followed for a minimum of 2 days and a maximum of 10 days.

Subject participation will run concurrently with the EMU admission. Exit from the study occurs when the subject's stay in the EMU is completed or the subject is withdrawn or withdraws from the study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Accelerometer Live-Streaming Tool	Other	The only 'intervention' that will take place is the placement of the XLS tool(s) on the upper left chest and/or left wrist of the patient.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate accelerometer data and tonic-clonic seizure data	The study will evaluate accelerometer data and tonic-clonic seizure data that was collected during the patients' EMU admission. The sample size is not based on a statistical power calculation, thus no primary endpoint is defined in the clinical investigation plan.	1.5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Four (4) years of age or older.
Admitted to an Epilepsy Monitoring Unit for video EEG monitoring.
Based on medical history, expected to have at least one seizure with tonic-clonic convulsive movement during the EMU stay as determined by the investigator.
Capable of understanding and willing to comply with instructions and study procedures.
Subject or guardian must be willing and able to complete informed consent/assent.

Exclusion Criteria:

Based on medical history, expected to have only non-epileptic events during the EMU stay as determined by the investigator.
Based on medical history, known to have only absence seizures.
Medical or psychiatric condition that in the investigator's judgment would prevent the subject's successful completion of the study.
Participants with known hypersensitivity or skin sensitivity conditions that will preclude attachment of the accelerometer.
Participants who are also taking part in another clinical trial that could confound the results of the study; these patients can be included into the study only if LivaNova has provided written approval.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who have been admitted to an EMU for video EEG monitoring (independent of this study) who are expected to have at least one seizure with tonic-clonic convulsive movement.

Sampling Method

Non-Probability Sample

ID	Term
D004829	Epilepsy, Generalized
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases