Trials / Completed
CompletedNCT02922153
The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- AtriCure, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cryoanalgesia | AtriCure® cryoICE cryo-ablation system |
| DRUG | Standard of Care | Institutional SOC for pain management will be followed. |
Timeline
- Start date
- 2016-06-13
- Primary completion
- 2019-03-04
- Completion
- 2019-08-28
- First posted
- 2016-10-04
- Last updated
- 2020-09-04
- Results posted
- 2020-09-04
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02922153. Inclusion in this directory is not an endorsement.