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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. (see Contacts and Locations)
Verified September 2016 by AtriCure, Inc.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT02922153
First received: September 26, 2016
Last updated: September 30, 2016
Last verified: September 2016
  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 Blind (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: November 2018
Estimated Primary Completion Date: December 2017 (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02922153

Contacts
Contact: William Beecher 414-418-7913 WBeecher@AtriCure.com

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cathie Bloem, RN    734-615-6170      
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         
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
Study First Received: September 26, 2016
Last Updated: September 30, 2016
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on May 25, 2017