CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Standard of Care +1 moredrug
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.

Search/NCT02922153
NCT02922153N/ACompleted

The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)

AtriCure, Inc.·interventional·Posted Oct 4, 2016·Updated Sep 4, 2020

In Brief

A clinical study evaluating Cryoanalgesia and Standard of Care for Pain. Completed, enrolled 84 participants across 5 sites.

Detailed Summary

The investigators propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior post-operative analgesic efficacy as compared to current pain management in patients undergoing unilateral thoracotomy cardiac procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 4, 2016
Enrollment StartJun 13, 2016
Primary CompletionMar 4, 2019
Study CompletionAug 28, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.7 years ago

Interventions

Cryoanalgesiadevice

AtriCure® cryoICE cryo-ablation system

Standard of Caredrug

Institutional SOC for pain management will be followed.