Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE September 26, 2016
First Posted Date  ICMJE October 4, 2016
Last Update Posted Date January 9, 2020
Study Start Date  ICMJE June 2016
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
  • Forced Expiratory Volume (FEV1) [ Time Frame: 48-hours post-surgery ]
  • Visual Analogue Scale (VAS) pain in the surgical region [ Time Frame: 48-hours post-surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
  • Spirometry assessments [ Time Frame: 48-hours post-extubation ]
  • Visual Analogue Scale (VAS) pain [ Time Frame: 72-, 96- and 120-hours Post-Op ]
  • Patient Controlled Analgesia (PCA) [ Time Frame: 24-, 48, -96 and 120-hours Post extubation ]
  • ICU length of stay [ Time Frame: Through discharge from ICU, on average 48-hours post-surgery ]
  • Adverse events related to the CryoAnalgesia procedure or device [ Time Frame: 30-days post-procedure ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
Official Title  ICMJE The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cryoanalgesia + SOC
    Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.
    Interventions:
    • Device: Cryoanalgesia
    • Drug: Standard of Care
  • 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.
    Intervention: Drug: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02922153
Other Study ID Numbers  ICMJE CP2015-4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AtriCure, Inc.
Study Sponsor  ICMJE AtriCure, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei Lau, MD William Beaumont Hospitals
PRS Account AtriCure, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP