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



Status:Recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 85
Updated:3/17/2019
Start Date:June 2016
End Date:August 2020
Contact:Nfii Ndikintum, PhD, MBA
Email:NNdikintum@AtriCure.com
Phone:513-644-8192

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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.


Inclusion Criteria:

- Patients undergoing unilateral thoracotomy cardiac procedures

- Acceptable surgical candidate, including use of general anesthesia

- Willing and able to provide written informed consent

- Willing and able to return for scheduled follow-up visits

Exclusion Criteria:

- Cardiac valve surgical procedure via conventional full sternotomy

- Procedures that require a posterolateral thoracotomy

- Current pregnancy

- Current use of prescription opioids

- FEV1 < 40% predicted

- Documented myocardial infarction within 30 days of signing IC

- Documented psychiatric disease

- Documented chronic pain syndrome

- Documented history of substance abuse

- Patient currently enrolled in another research study

- Physical or mental condition that could impact assessment of pain

- Disqualifying medical condition per investigator
We found this trial at
4
sites
225 Smith Avenue North
Saint Paul, Minnesota 55102
Principal Investigator: John Grehan, MD
Phone: 651-241-2216
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Steven Bolling, MD
Phone: 734-232-4297
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Los Angeles, California 90007
Principal Investigator: Vaughn Starnes, MD
Phone: 323-442-6226
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Los Angeles, CA
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Royal Oak, Michigan 48073
Principal Investigator: Wei Lau, MD
Phone: 248-551-6059
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Royal Oak, MI
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