Intercostal Cryoanalgesia in Double Lung Transplant Recipients

NCT ID: NCT07281118

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2027-11-24

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.

Detailed Description

This study is being done to learn whether a special cold-therapy treatment can help control pain after a double lung transplant. During the surgery, doctors may use a device called the Atricure CryoSPHERE MAX Probe, which gently freezes the nerves around the incision to reduce pain for several days. This freezing effect may help patients need fewer opioid pain medicines, which can sometimes cause sleepiness or make it harder to breathe deeply after surgery. Researchers will compare patients who receive the cryotherapy treatment to patients who receive the usual care without the device.

The main goal is to see whether the cryotherapy group uses at least 25% fewer opioids in the first 10 days after surgery. The study will also look at how often patients still need extra pain treatments, such as an epidural, and whether their average daily pain scores are lower. Another important question is whether the treatment can help shorten the amount of time patients need to stay in the ICU. About 148 people from several hospitals will take part in the study. Everyone who joins the study will be followed for one year after their transplant to monitor their recovery and any long-term effects of the treatment.

Conditions

Post-operative Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Treatment Arm

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

Group Type: EXPERIMENTAL

Atricure CryoSPHERE MAX Probe

Intervention Type: 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.

Usual Care

No treatment intra-operatively

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: DEVICE

Other Intervention Names

Cryotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AtriCure, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Abbas Ardehali, MD

Professor of Surgery and Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abbas Ardehali, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California San Francisco

San Francisco, California, United States

Baylor University

Waco, Texas, United States

Countries

United States

Central Contacts

Steven Stokes

Role: CONTACT

sstokes@mednet.ucla.edu

310-206-7436

Jenny Lester, MPH

Role: CONTACT

jlester@mednet.ucla.edu

310-794-9728

Other Identifiers

IRB-24-6029

Identifier Type: -

Identifier Source: org_study_id