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

This study is currently recruiting participants.
Verified June 2017 by AtriCure, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02922153
First Posted: October 4, 2016
Last Update Posted: September 15, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AtriCure, Inc.
  Purpose
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 Intervention
Pain Device: Cryoanalgesia Drug: Standard of Care

Study Type: Interventional
Study Design: 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)

Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: June 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Denise Breiner, MBA 513-658-9643 DBreiner@AtriCure.com

Locations
United States, California
University of Southern California (USC) Recruiting
Los Angeles, California, United States, 90033
Contact: Stephanie Mullin    323-442-6226    Stephanie.Mullin@med.usc.edu   
Contact: Derrick Dubon    323-442-7894    Derrick.Dubon@med.usc.edu   
Principal Investigator: Vaughn Starnes, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cathie Bloem, RN    734-615-6170    bloem@med.umich.edu   
Principal Investigator: Steven Bolling, MD         
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Julie VanRaemdonck, RN, BSN    248-551-6059    Julie.VanRaemdonck@beaumont.org   
Principal Investigator: Wei Lau, MD         
United States, Minnesota
United Heart and Vascular Institute - Allina Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Christine Jablonski    651-241-2816    Christine.Jablonski@allina.com   
Principal Investigator: John Grehan, MD         
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Principal Investigator: Wei Lau, MD University of Michigan
  More Information

Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT02922153     History of Changes
Other Study ID Numbers: CP2015-4
First Submitted: September 26, 2016
First Posted: October 4, 2016
Last Update Posted: September 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by AtriCure, Inc.:
CryoAnalgesia
Thoracotomy
FEV1
VAS