Study to Evaluate a New Device Designed to Collect Heart... | NCT01626599

NCT01626599

Protocol Section

Identification Module

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

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Assess product useability	Other	All subjects participate in the same arm. This arm completes the primary objective of product usability.	Device: ProGuardian

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ProGuardian	Device	The investigational system is composed of a sensor, patch, hub, and caregiver application. The sensor is applied externally during periods of nocturnal sleep for up to 7 nights. The investigational system: is not implantable and no surgical procedure is required for a human subject to use the devices; is not for use in supporting or sustaining a human life; and is not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health. Contains skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess product useability	This study is designed to collect usability data from the intended use population of people with epilepsy and their caregivers to support development of a novel product designed to capture ECG signals and accelerometer data.	Up to 7 nights/7 days

Secondary Outcomes

Measure	Description	Time Frame
Collect ECG and accelerometer data; device wearability; and evaluate adverse events.	Assess ECG and accelerometer data, device adhesion and dermal response	Up to 7 nights/7 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria:

Five (5) years of age or older
Caregiver capable of understanding and willing to comply with instructions provided in English for proper use of the study device as well as scheduled study visits.
Guardian/Parent for subjects less than 18 years or with cognitive limitation that would preclude consent must be willing and able to complete informed consent/and HIPAA authorization.
A self-reported diagnosis of epilepsy.
Currently taking at least one antiepileptic medication.

Caregivers must meet the following inclusion criteria:

Eighteen (18) years of age or older
Capable of understanding and willing to comply with instructions provided in english for proper use of the study device as well as scheduled study visits
Willing and able to complete informed consent and HIPAA authorization.

Exclusion Criteria:

Subjects are not eligible to be enrolled in the study if they meet any of the following exclusion criteria:

Any visible skin disorder, condition, or abnormal skin pigmentation which, in the investigators opinion, would interfere with the ability to wear the patch.
History of chronic dermatological, medical, or physical conditions that would, in the investigators opinion, preclude topical application of the test products and/or influence the outcome of the test.
Known sensitivity or history of irritation to adhesive tape (Latex) and/or topically applied products
An implanted defibrillator and/or pacemakers
Severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
Pregnant and or nursing women (verified by a urine pregnancy test).
Currently participating in another clinical study without sponsor approval.
Caregiver that is unable to read instructions in the English language.

Exclusion Criteria for Caregiver:

Under 18 years of age
Not capable of understanding and willing to comply with instructions provided in English for proper use of the study device as well as scheduled study visits

Facility	Status	City	State	ZIP	Country	Contacts
United States, Illinois		Chicago	Illinois	60654	United States
United States, North Carolina

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases