Actively Recruiting
Intercostal Cryoanalgesia in Double Lung Transplant Recipients
Led by University of California, Los Angeles · Updated on 2026-03-05
148
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
A
AtriCure, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a new method to manage pain after a double lung transplant. It focuses on whether using a cold-therapy probe during surgery can reduce the need for opioid pain medicines and improve recovery. The study compares patients receiving this cold treatment to those receiving usual care to understand its impact on pain control and opioid use. During surgery, some patients will receive treatment with the Atricure CryoSPHERE MAX Probe, which gently freezes nerves around the incision to numb pain for several days. This device is applied to two intercostal spaces above and below the thoracotomy incision for one minute each time during the transplant procedure. Other patients will receive the standard care without this device. The study follows participants for one year after their transplant to assess long-term effects. Participants will be closely monitored through the first 10 days after surgery for opioid use, pain scores, need for additional pain treatments, and time spent in the intensive care unit. Researchers will measure total opioid use over one year and track recovery progress. Safety and recovery will be observed with ongoing follow-up visits throughout the year to understand how well this cold-therapy method helps patients after lung transplant surgery.
CONDITIONS
Brief Title
Intercostal Cryoanalgesia in Double Lung Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 6ge;18 years of age
- Undergoing double lung transplantation via bilateral thoracotomies or clamshell incision
You will not qualify if you...
- Multi-organ transplant recipients
- Redo lung transplant recipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and first 10 days after surgery
Participants undergo double lung transplant surgery. Some receive a cold-therapy treatment using a device that freezes nerves around the incision to reduce pain during and shortly after surgery.
Daily in-hospital visits during initial recovery
Duration - Up to 1 year after transplant
Participants are followed for recovery and monitoring of pain, opioid use, and ICU stay after surgery.
Regular follow-up visits over 1 year
Trial Site Locations
Total: 3 locations
1
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
3
Baylor University
Waco, Texas, United States, 76706
Not Yet Recruiting
Research Team
S
Steven Stokes
J
Jenny Lester, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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