At a glance
ClinicalIndex Comparison RecordN/ACompleted· 110 enrolled
Drug / intervention
Renamic Neo programmer device, including software; PK-222-L ECG cabledevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BIO|CONCEPT.Renamic Neo
In Brief
An observational study evaluating Renamic Neo programmer device, including software; PK-222-L ECG cable for Medical Devices. Completed, enrolled 110 participants across 8 sites.
Detailed Summary
The BIO\|CONCEPT.Renamic.Neo study is designed as a pre-market study to provide clinical data and supporting evidence of the safety, performance and usability of the Renamic Neo programmer system.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMedical Devices
CountriesAustralia
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedApr 2020
Enrollment StartJun 2020
Primary CompletionOct 2020
TodayJul 2026
First PostedApr 16, 2020
Enrollment StartJun 8, 2020
Primary CompletionOct 29, 2020
TodayJul 3, 2026
Enrollment to primary: 5 monthsPosted 6.2 years ago
Interventions
Renamic Neo programmer device, including software; PK-222-L ECG cabledevice
Patients were enrolled either for implantation including subsequent pre-hospital discharge or for a follow-up visit only. ICM patients were included for follow-ups only. Implants were programmed and interrogated by using the investigational devices.