Post-operative Pain ManagementNCT07281118
Intercostal Cryoanalgesia in Double Lung Transplant Recipients
A study testing Atricure CryoSPHERE MAX Probe in people with Post-operative Pain Management, run by University of California, Los Angeles at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain Management
- What is being tested?
- Atricure CryoSPHERE MAX Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Dec 2025to 24 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age
- Undergoing double lung transplantation via bilateral thoracotomies or clamshell incision
Who cannot join
- Multi-organ transplant recipients
- Redo lung transplant recipients
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Steven Stokes, 310-794-206-7436, sstokes@mednet.ucla.edu
Jenny Lester, MPH, 310-794-9728, jlester@mednet.ucla.edu
- Not yet recruiting
University of California San Francisco
San Francisco, California, 94143
- Not yet recruiting
Baylor University
Waco, Texas, 76706
About this study
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.
Read the 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
- Being tested
- Atricure CryoSPHERE MAX Probe
- Keywords
- Lung Transplant, Pain Management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atricure CryoSPHERE MAX ProbeDevice
Also called Cryotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Patients will be treated intra-operatively with Atricure CryoSPHERE MAX Probe to 2 Receives: Device: Atricure CryoSPHERE MAX Probe |
| Usual Care | No intervention | No treatment intra-operatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid use (oral morphine equivalents)
Total opioid use (oral morphine equivalents)
Measured: 1 year
Secondary outcomes (3)
Frequency of rescue therapy
Compare need for thoracic epidural anesthesia.
Measured: 1 year
Median daily pain score
To compare the Median daily pain score for the first 10 days after lung transplantation, Numerical Rating Scale (NRS) (0-10): A standard 11-point scale (0=no pain, 10=worst imaginable pain) used for pain intensity, showing good reliability and validity in various conditions like neuropathic pain.
Measured: Day 10
Duration of ICU Stay
To compare the duration of the ICU stay
Measured: Days 1-10, 30 days, 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start16 Dec 2025
- Primary completion24 Nov 2027 (estimated)
- Study completion24 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Pain ManagementStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- AtriCure, Inc.
- Responsible party
- Principal investigator, Abbas Ardehali, MD, University of California, Los Angeles
- Investigators
- Abbas Ardehali, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281118
- Sponsor's protocol ID
- IRB-24-6029
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Summary data and results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercostal Cryoanalgesia in Double Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT07281118
- Acronym / sponsor ID
- IRB-24-6029
- Conditions
- Post-operative Pain Management
- Keywords
- Lung Transplant, Pain Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- AtriCure, Inc.
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 24 Nov 2027 (estimated)
- Study completion
- 24 Nov 2027 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Atricure CryoSPHERE MAX ProbePatients will be treated intra-operatively with Atricure CryoSPHERE MAX Probe to 2 |
| Usual Care | No intervention | –No treatment intra-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥18 years of age
- Undergoing double lung transplantation via bilateral thoracotomies or clamshell incision
Key exclusion criteria (2 listed)
- Multi-organ transplant recipients
- Redo lung transplant recipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atricure CryoSPHERE MAX ProbeAlso: CryotherapyPatients 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. | Device | Treatment Arm |
Primary outcome
Total opioid use (oral morphine equivalents)
Time frame: 1 year
Total opioid use (oral morphine equivalents)
3 secondary outcomes
Frequency of rescue therapy
Time frame: 1 year
Median daily pain score
Time frame: Day 10
Duration of ICU Stay
Time frame: Days 1-10, 30 days, 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No. Summary data and results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abbas Ardehali, MD principal investigator
University of California, Los Angeles
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atricure CryoSPHERE MAX Probe in people with Post-operative Pain Management, run by University of California, Los Angeles at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Stokes (310-206-7436, sstokes@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid use (oral morphine equivalents) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.