Recruiting

Cryoablation

Sponsor:

University of Michigan

Code:

NCT06384664

Conditions

Pain, Postoperative

Intrathoracic Procedure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Atricure's crysoSPHERE probe

Standard of Care

Study Details

Brief summary:

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.

Conditions

Pain, Postoperative

Intrathoracic Procedure

Study ID

NCT06384664

Start date

Jun 3, 2024

Status verified date

Aug, 2025

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine
  • Patient is opioid naïve

Exclusion Criteria:

  • Patients who are pregnant
  • Patients with cognitive impairment
  • Patients with psychological disorders
  • Patients with prior thoracic surgery
  • Patients with fibromyalgia
  • Patients with redo ipsilateral thoracic surgery
  • Patients undergoing bilateral thoracotomy

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Atricure's crysoSPHERE probe

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

An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.

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 ]
  • Inflammatory cytokine levels as measured by blood samples [ Time Frame: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery ]
  • Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score [ Time Frame: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery ]
  • Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) [ Time Frame: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop ]
  • Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) [ Time Frame: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop ]

Central Contacts and Locations

Central contacts

Shari L Barnett

734-936-4561shbailey@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Shari L Barnett

734-936-4561shbailey@umich.edu

Principal Investigator:

Rishindra Reddy, MD, MBA

More Information

Sponsor

University of Michigan

Last update posted

Aug 28, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-08-28.