A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves
ConditionPost Operative Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorAtriCure, Inc.
About this trial
This is a retrospective and prospective, multicenter, observational patient registry to record outcomes from patients undergoing cryoablation of the intercostal nerves (cryoanalgesia) for post-operative pain management.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients whose age is 12 years or above, and are able to give informed consent/assent specific to state and national law.
Patients have been scheduled by physician(s) to undergo or have undergone cryoablation of the intercostal nerves utilizing at least one AtriCure device or are similar patients treated without the use of cryoablation
Disqualifiers
Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.
Patient with exclusion criteria required by local governance.
Women of childbearing potential who are, or plan to become, pregnant during the time of the study
Trial population
The REDUCE registry eligibility is open to sites and physicians performing cryo nerve block procedures as treatments for patients to generate croanalgesia as a post operative pain management method using the AtriCure Cryo Nerve Block (cryoNB) Device Family. Subjects must have been scheduled to undergo or have undergone the cryo nerve block procedure and must meet all eligibility criteria in order for their treatment and results to be considered for this registry.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
AtriCure Cryo Nerve Block (cryoNB) Device Family
DeviceUse of Atricure Cryo Nerve Block Device Family to generate cryoanalgesia for the management of post operative pain.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management
Collect pain score to assess the effect of cryoanalgesia effect with a follow up duration of up to 5 years.
Time frame
From enrollment to 5 years after date of index procedure2
Safety of cryo nerve block to generate cryoanalgesia as post operative pain management
Collect adverse events occurred during and post operation to assess the safety of the cryo nerve block procedure.
Time frame
From enrollment to 5 years after date of index procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov