Pain, PostoperativeNCT06384664
Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy
A study testing Atricure's crysoSPHERE probe in people with Pain, Postoperative and Intrathoracic Procedure, run by University of Michigan at 1 site in United States.
Trial summary
The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Intrathoracic Procedure
- What is being tested?
- Atricure's crysoSPHERE probe
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to Apr 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine
- Patient is opioid naïve
Who cannot join
- Patients who are pregnant
- Patients with cognitive impairment
- Patients with psychological disorders
- Patients with prior thoracic surgery
- Patients with fibromyalgia
- Patients with redo ipsilateral thoracic surgery
- Patients undergoing bilateral thoracotomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Shari L Barnett, 734-936-4561, shbailey@umich.edu
Rishindra Reddy, MD, MBA
About this study
The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.
- Conditions
- Pain, Postoperative, Intrathoracic Procedure
- Being tested
- Atricure's crysoSPHERE probe, Standard of Care
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atricure's crysoSPHERE probeDevice
Also called cryoablation
Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.
Standard of CareProcedure or surgery
Also called Intercostal nerve block
An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intercostal nerve block | Active comparator | Standard of care Receives: Procedure: Standard of Care |
| Cryoablation | Experimental | Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas. Receives: Device: Atricure's crysoSPHERE probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of pain in the peri-operative period
Pain measured using a numeric rating scale ranging from 1-10 where a higher pain score indicates more pain severity
Measured: Post-op day 1 and day of hospital discharge, approximately 3 days
Inflammatory cytokine levels as measured by blood samples
Levels are measured using blood sample collection and assay specifically assessing IL-1, IL-6, TNF-a
Measured: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score
Correlations with the pain scores from outcome #1
Measured: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity surveys
Measured: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop
Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
assessment of feeling or touching sensations along the thoracic cavity measured using dermatone assessment
Measured: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop
Secondary outcomes (3)
Quality of life score as measured by SF-36 Health questionnaire
36 item survey instrument
Measured: baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op.
Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management)
Hospital charges for cases that get standard of care postop pain management versus cases that receive cryoablation.
Measured: Up to 180-days postop
Workflow/time
Including items such as length of operating room use and length of hospital stay
Measured: Up to 180-days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start3 Jun 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- AtriCure, Inc.
- Responsible party
- Principal investigator, Rishindra Reddy, University of Michigan
- Investigators
- Rishindra Reddy, MD, MBA, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384664
- Sponsor's protocol ID
- HUM00241242
- Status last verified
- Aug 2025
- First submitted
- 15 Apr 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy
- ClinicalTrials.gov ID
- NCT06384664
- Acronym / sponsor ID
- HUM00241242
- Conditions
- Pain, Postoperative, Intrathoracic Procedure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- AtriCure, Inc.
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 25 Apr 2024 (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.
The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercostal nerve block | Active comparator | Procedure: Standard of CareStandard of care |
| Cryoablation | Experimental | Device: Atricure's crysoSPHERE probeCryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine
- Patient is opioid naïve
Key exclusion criteria (7 listed)
- Patients who are pregnant
- Patients with cognitive impairment
- Patients with psychological disorders
- Patients with prior thoracic surgery
- Patients with fibromyalgia
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's crysoSPHERE probeAlso: cryoablationCryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas. | Device | Cryoablation |
| Standard of CareAlso: Intercostal nerve blockAn intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery. | Procedure or surgery | Intercostal nerve block |
Primary outcome
Severity of pain in the peri-operative period
Time frame: Post-op day 1 and day of hospital discharge, approximately 3 days
Pain measured using a numeric rating scale ranging from 1-10 where a higher pain score indicates more pain severity
Inflammatory cytokine levels as measured by blood samples
Time frame: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
Levels are measured using blood sample collection and assay specifically assessing IL-1, IL-6, TNF-a
Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score
Time frame: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
Correlations with the pain scores from outcome #1
Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
Time frame: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity surveys
Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
Time frame: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop
assessment of feeling or touching sensations along the thoracic cavity measured using dermatone assessment
3 secondary outcomes
Quality of life score as measured by SF-36 Health questionnaire
Time frame: baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op.
Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management)
Time frame: Up to 180-days postop
Workflow/time
Time frame: Up to 180-days postop
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 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Rishindra Reddy, MD, MBA principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atricure's crysoSPHERE probe in people with Pain, Postoperative and Intrathoracic Procedure, run by University of Michigan at 1 site 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 7 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 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Shari L Barnett (734-936-4561, shbailey@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of pain in the peri-operative period (time frame: Post-op day 1 and day of hospital discharge, approximately 3 days). The study lists 5 primary outcomes in all. 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 28 Aug 2025.