Intercostal Cryoanalgesia in Double Lung Transplant Recipients

NCT07281118 | Recruiting DMC FDA Device

• 1 other identifier: IRB-24-6029
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 3

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

Keywords

Lung Transplant; Pain Management

Outcome Measures

Primary Outcomes (1)

• Total opioid use (oral morphine equivalents)

  Total opioid use (oral morphine equivalents)

  1 year

Secondary Outcomes (3)

• Frequency of rescue therapy

  1 year

• Median daily pain score

  Day 10

• Duration of ICU Stay

  Days 1-10, 30 days, 60 days

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Device: Atricure CryoSPHERE MAX Probe

Usual Care

NO INTERVENTION

No treatment intra-operatively

Interventions

Atricure CryoSPHERE MAX Probe DEVICE

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.

Also known as: Cryotherapy

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Multi-organ transplant recipients
• Redo lung transplant recipients

Sponsors & Collaborators

• University of California, Los Angeles: lead
• AtriCure, Inc.: collaborator

Study Sites (3)

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

NOT YET RECRUITING

Baylor University

Waco, Texas, 76706, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Abbas Ardehali, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Stokes

CONTACT

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

Jenny Lester, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery and Medicine

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 15, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): November 24, 2027
• Study Completion (Estimated): November 24, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)