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NCT01626599 · ClinicalTrials.gov registry record · NA

Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data

A NA study, sponsored by Cyberonics.

Completed
Registry status
NA
Development phase
147
Enrollment target

NCT01626599: Completed NA study, sponsored by Cyberonics.

NCT01626599 is a NA study that has completed, run by Cyberonics. The registered enrollment target is 147 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01626599, a NA study, has completed, sponsored by Cyberonics.

COMPLETED
Registry status
NA
Development phase
147 participants
Enrollment target

Study Summary

This study is designed to collect data to support development of a novel product designed to sense changes in heart rate or movement during periods of sleep in people with epilepsy. When a potential seizure is detected, the system sends out an audio-visual notification.

Primary Outcome

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.

Interventions

  • DEVICE ProGuardian

Trial Details

FieldValue
Enrollment Target 147 participants
Start Date 2012-06
Est. Completion 2014-04
Phase NA
Cyberonics

15 total trials

What the finished NCT01626599 record still lists

NCT01626599 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which ProGuardian is the first listed.

NCT01626599 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01626599 about?

NCT01626599 is a clinical study titled "Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data". This study is designed to collect data to support development of a novel product designed to sense changes in heart rate or movement during periods of sleep in people with epilepsy. When a potential seizure is detected, the system sends out an audio-visual notification.

What is the current status of trial NCT01626599?

This trial is currently completed. It is a NA study. The enrollment target is 147 participants. The study started on 2012-06. Estimated completion is 2014-04.

What interventions are being tested in trial NCT01626599?

The interventions under investigation include: ProGuardian (DEVICE).

Who is sponsoring clinical trial NCT01626599?

This trial is sponsored by Cyberonics, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01626599's enrollment target sits among peer trials

147 703rd of 2000 higher than 1,297 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01626599, the US trial registry maintained by the National Library of Medicine. NCT01626599 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.