Recruiting

Cold-Therapy ProbeIntercostal Cryoanalgesia in Double Lung Transplant Recipients

Sponsor:

UCLA

Code:

NCT07281118

Conditions

Post-operative Pain Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atricure CryoSPHERE MAX Probe

Study Details

Brief summary:

This study is testing a new way to help manage pain after a double lung transplant. Instead of relying only on strong pain medicines like opioids, doctors will use a cold-therapy probe during surgery to help numb the nerves near the incision. Researchers want to see if this method can reduce the need for opioids and improve recovery.

Conditions

Post-operative Pain Management

Study ID

NCT07281118

Start date

Dec 16, 2025

Status verified date

Mar, 2026

Completion date

Nov 24, 2027

Anticipated

Primary completion date

Nov 24, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Adults ≥18 years of age
Undergoing double lung transplantation via bilateral thoracotomies or clamshell incision

Exclusion Criteria:

Multi-organ transplant recipients
Redo lung transplant recipients

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

Patients will be treated intra-operatively with Atricure CryoSPHERE MAX Probe to 2

no intervention: Usual Care

No treatment intra-operatively

Interventions

Atricure CryoSPHERE MAX Probe

Patients will be treated intra-operatively with Atricure CryoSPHERE MAX Probe to 2 intercostal spaces above and below the thoracotomy incision for 1 minutes for each application during their double lung transplant procedure.

Primary outcome measure

Total opioid use (oral morphine equivalents) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Steven Stokes

310-206-7436 sstokes@mednet.ucla.edu

Jenny Lester, MPH

310-794-9728 jlester@mednet.ucla.edu

Locations

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Steven Stokes

310-794-206-7436 sstokes@mednet.ucla.edu

Jenny Lester, MPH

310-794-9728 jlester@mednet.ucla.edu

Principal Investigator:

Abbas Ardehali, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

Lung Transplant
Pain Management

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 California, Los Angeles on 2026-03-05.