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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922153
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Device: Cryoanalgesia Drug: Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
Study Start Date : June 2016
Actual Primary Completion Date : December 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cryoanalgesia + SOC
Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.
Device: Cryoanalgesia
AtriCure® cryoICE cryo-ablation system
Other Name: cryoICE

Drug: Standard of Care
Institutional SOC for pain management will be followed.
Other Name: SOC

Active Comparator: Standard of Care
Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.
Drug: Standard of Care
Institutional SOC for pain management will be followed.
Other Name: SOC




Primary Outcome Measures :
  1. Forced Expiratory Volume (FEV1) [ Time Frame: 48-hours post-surgery ]
  2. Visual Analogue Scale (VAS) pain in the surgical region [ Time Frame: 48-hours post-surgery ]

Secondary Outcome Measures :
  1. Spirometry assessments [ Time Frame: 48-hours post-extubation ]
  2. Visual Analogue Scale (VAS) pain [ Time Frame: 72-, 96- and 120-hours Post-Op ]
  3. Patient Controlled Analgesia (PCA) [ Time Frame: 24-, 48, -96 and 120-hours Post extubation ]
  4. ICU length of stay [ Time Frame: Through discharge from ICU, on average 48-hours post-surgery ]
  5. Adverse events related to the CryoAnalgesia procedure or device [ Time Frame: 30-days post-procedure ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922153


Locations
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United States, California
University of Southern California (USC)
Los Angeles, California, United States, 90033
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
United Heart and Vascular Institute - Allina
Saint Paul, Minnesota, United States, 55102
Sponsors and Collaborators
AtriCure, Inc.
Investigators
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Principal Investigator: Wei Lau, MD William Beaumont Hospitals

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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT02922153    
Other Study ID Numbers: CP2015-4
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AtriCure, Inc.:
CryoAnalgesia
Thoracotomy
FEV1
VAS