Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06384664
Status
Recruiting
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Conditions

  • Intrathoracic Procedure
  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Atricure's crysoSPHERE probe — DEVICE
    Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.
  • Standard of Care — PROCEDURE
    An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.

Study Details

The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.

Key Dates

Start date
Jun 3, 2024
Status verified
Aug 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Intercostal nerve block
    Standard of care
  • Experimental: Cryoablation
    Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.

Primary Outcome Measure

Severity of pain in the peri-operative period [ Time Frame: Post-op day 1 and day of hospital discharge, approximately 3 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Shari L Barnett
[email protected]
734-936-4561
Rishindra Reddy, MD, MBA (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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