Rib FracturesUNPINNCT05865327
UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture
A study testing Cryoneurolysis in people with Rib Fractures and Rib Fracture Multiple, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Traumatic rib fractures (i.e., broken ribs caused by a physical injury) are common and very painful. They also often lead to serious complications, more time spent in hospital, and can even lead to death. Even after rib fractures have healed, they can lead to long-term pain and a lower quality of life. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rib Fractures, Rib Fracture Multiple, Rib; Fracture, With Flail Chest
- What is being tested?
- Cryoneurolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 23 Oct 2023to Dec 2025
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18
- Unilateral traumatic rib fractures (3 to 8)
- Candidate for ESP block catheter
- Within 48hrs of admission to hospital
Who cannot join
- Lack of patient consent; unlikely to comply with follow up
- Unable to use Patient Controlled Regional Analgesia (Ventilated/sedated patients or Moderate to severe traumatic brain injury)
- Chronic pain (opioid use > 30mg oral morphine equivalent per day)
- Substance use disorder
- CrCl < 50
- BMI > 45
Show all 10Show fewer
- Significant distracting injuries (unreduced long bone fractures, unstable pelvic or spine fractures and patients requiring trauma laparotomy- also preclude positioning for block placement (lateral decubitus or sitting up))
- Contraindications for ESP catheter placement (pre-existing medical/neurological/hematologic diseases, localized infection/trauma at site of intervention, allergy to amide local anesthetics)
- Contraindications to CN (cryoglobulinemia, paroxysmal cold hemoglobinuria, multiple myeloma and cold urticarial).
- Unable to return to Trauma Recovery Clinic (in-person or virtual) at 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Ben Safa, 416 480 4864, ben.safa@sunnybrook.ca
About this study
Official title: UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture, a Pilot Randomized Control Trial (UNPIN Trial)
Traumatic rib fractures (i.e., broken ribs caused by a physical injury) are common and very painful. They also often lead to serious complications, more time spent in hospital, and can even lead to death. Even after rib fractures have healed, they can lead to long-term pain and a lower quality of life.
A technology called cryoneurolysis, which acts to freeze nerves causing pain using a small tool which can turn very cold, is a promising new way to manage rib fracture pain. This study is a test with a small number of people to see if it is feasible to use this technology for patients with rib fractures. If this is successful, we will recruit more people for a larger study to see if cryoneurolysis, along with standard pain control techniques, is better at stopping pain, compared to just the normal techniques alone. Participants in our study will be asked to rate their pain, and record pain medications that they take for 3 months after their pain procedure.
Read the detailed description
More than 100,000 people a year suffer from traumatic rib fractures. Pain from rib fractures impairs the ability to inspire deeply and cough effectively, predisposing patients to severe, potentially life threatening complications and increased healthcare costs. For many patients, this pain can also persist long after the acute injury has healed, delaying recovery and reducing quality of life.
Current pain interventions, including multimodal analgesia and local anesthetic-based nerve blocks, are useful, but are limited by a short duration of effectiveness, and/or risk of complications. Cryoneurolysis (CN) is a new method to control pain which acts to freeze intercostal nerves (ICNs) associated with fractured ribs using a handheld device. This freezing action causes neurons to undergo Wallerian degeneration distally from the site of ablation and thus exhibit an extended but reversible block.
This study is a single-site, randomized, pilot study to assess the feasibility of recruitment, randomization, and protocol adherence of providing cryoneurolysis for patients with traumatic rib fractures. Secondary data from the pilot trial designed to assess the effectiveness of the intervention (pain scores, opioid usage, etc.) will be included in the analysis of the full trial if feasible. The objective of the full trial is to demonstrate that cryoneurolysis of ICN, in addition to standard analgesic practice, provides superior, prolonged analgesia.
Participants (individuals aged 18-85, with 3-8 unilateral traumatic rib fractures) will be randomized 1:1 in blocks of 4, stratified by number of rib fractures (> 4 or ≤4) and the presence/absence of flail segment, to receive the current standard of practice for rib fractures (multimodal analgesia and erector spinae plane (ESP) catheter infusion) with or without the addition of CN. Participants in the standard care group will receive a sham CN procedure to maintain blinding.
All participants (both groups) will receive standard of care analgesia. Specifically, an ultrasound-guided ESP catheter will be placed as per standard protocols. 20cc of 0.5% ropivacaine and 1% lidocaine will be injected through the catheter, followed by a basal infusion of 2 cc/hr of 0.2% ropivacaine (to maintain catheter patency) with an on demand patient controlled regional anesthesia (PCRA) dose of 10cc 0.2% ropivacaine available hourly until patient has met criteria for APS discharge or pain is controlled such that PCRA use is < 2 boluses over 12 hrs and NRS < 3 with deep breathing and coughing.
Standard multimodal analgesia including Tylenol 1000mg QID, Celebrex 200mg BID (or ketorolac 7.5 QID), Pregabalin 50mg BID, and/or PRN oral hydromorphone (1-4mg) will also be provided. Additional analgesics include intravenous ketamine at a dose of 0.1-0.2 mg/kg/hr of lean body weight in the event of consistent NRS pain scores > 6, and up to 0.05 mg/kg of intravenous midazolam for anxiolysis and 1mcg/kg of intravenous fentanyl for comfort during positioning, as required.
Participants will remain in the study for 3 months from the date of the block procedure. They will be followed daily while in hospital and using a pain diary following discharge (weekly pain scores and daily opioid usage). Additionally, follow-ups will be completed at 1h, 24h, 48h, 1 week, 1 month, and 3 months post block procedure.
- Conditions
- Rib Fractures, Rib Fracture Multiple, Rib; Fracture, With Flail Chest, Pain, Pain, Acute, Pain, Chronic
- Being tested
- Cryoneurolysis, Sham Cryoneurolysis
- Keywords
- Cryoneurolysis, Rib Fracture Pain, Intercostal Nerve Block
- Medical subject headings
- Rib Fractures, Fractures, Bone, Pain, Acute Pain, Chronic Pain, Wounds and Injuries, Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurolysisProcedure or surgery
Cryoneurolysis will be performed on the intercostal nerve associated with each fractured rib using a handheld cryoneurolysis machine (Iovera). Cryoneurolysis will consist of two 103 second cycles (includes cooling, ice ball formation and warming time) per rib fracture level. Ultrasound guidance will be used to identify appropriate rib fracture levels and to target the device tip in real time. All participants will also receive standard multimodal analgesia and ESP catheter infusion.
Sham CryoneurolysisProcedure or surgery
Participants in the control group will receive sham CN (i.e., application of device without skin puncture or activation of unit) to maintain participant blinding. All participants will also receive standard multimodal analgesia and ESP catheter infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cryoneurolysis Group | Experimental | In addition to all standard of care analgesia treatments, CN will be performed on the ICN of each broken rib using the Iovera CN device and Generation 2 Iovera tip under ultrasound guidance. Receives: Procedure: Cryoneurolysis |
| Standard Care Group | Sham comparator | Participants in the control group will receive all standard of care analgesia treatments as well as sham CN (i.e., application of device without skin puncture or activation of unit) to maintain participant blinding. Receives: Procedure: Sham Cryoneurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants randomized over an 8 month period
Goal of 3 participants per month for 8 months
Measured: Entire pilot study (approximately 8 months)
Number of participants able to adhere to the protocol
Goal of > 90%
Measured: Entire pilot study (approximately 8 months + 3 month follow-up)
Number of participants able to adhere to the follow-up
Goal of > 90%
Measured: 3 month follow-up
Rate of Adverse events
Ensure no adverse events (short or long term) associated with CN
Measured: 3 month follow-up
Secondary outcomes (16)
Pain Severity during deep inspiration 24 hours post ESP catheter placement
Pain measured using Numeric Pain Rating Scale
Measured: 24 hours post placement of ESP catheter
Time to discontinuation of ESP catheter
Based on when patient has met criteria for APS discharge or pain is controlled such that PCRA use is < 2 boluses over 12 hrs and NRS < 3 with deep breathing and coughing
Measured: Until ESP catheter removal (usually < 7 days)
ESP catheter use
Cumulative volume of local anesthetic solution used via ESP catheter patient controlled reginal analgesia
Measured: Until ESP catheter removal (usually < 7 days)
Opioid consumption in hospital and after discharge
Determined from medical records (in-hospital) and via a daily pain diary (post-discharge). Calculated in Oral Morphine Equivalents.
Measured: Daily for 90 days after block placement
Pain Intensity at 1 and 3 months
As measured using Numeric Pain Rating Scale (0-10) , at rest and during deep inspiration
Measured: 1 and 3 month follow-ups
Oxygen requirements
Room air oxygen saturation (SpO2) and requirement for supplementary O2 to maintain SpO2 > 92%
Measured: Pre-intervention, post intervention, then daily until discharge
Pulmonary Function Testing
FVC
Measured: Pre-intervention, post intervention, then daily until discharge
Pulmonary Function Testing
FEV1
Measured: Pre-intervention, post intervention, then daily until discharge
Pulmonary Function Testing
Peak Inspiratory flow
Measured: Pre-intervention, post intervention, then daily until discharge
Pulmonary Function Testing
Peak Expiratory Flow
Measured: Pre-intervention, post intervention, then daily until discharge
Length of Stay in hospital
Hospital discharge date
Measured: Date of admission to date discharge
Length of Stay on acute pain service (APS)
Criteria include on oral meds without continuous regional analgesia or intravenous opioids
Measured: Date of admission to date of discharge from acute pain service
Time to achieve discharge criteria for isolated chest injury
Criteria include on oral meds without continuous regional analgesia, chest tube out and chest well evacuated (e.g. no evidence of retained hemothorax), and no supplemental O2
Measured: Date of admission until discharge criteria met
Patient satisfaction
Patient satisfaction assessed using Patients' Global Impression of Change (PGIC) scale
Measured: 48 post block procedure, and 1 week, 1 month and 3 month follow-ups
Incidence of chronic rib fracture pain
As assessed using Brief Pain Inventory (BPI) questionnaire
Measured: 3 month follow-up
Adverse events
Adverse events to be recorded include: local anesthetic complications, catheter related complications (clotting, migration), procedural complications (pneumothorax, bleeding, infection), and neurological disturbances (dysesthesia, hyperalgesia, allodynia) in area of rib fracture
Measured: until 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start23 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, prospective, parallel, randomized, blinded (participant, data collectors/analysts) pilot feasibility trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ben Safa, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865327
- Sponsor's protocol ID
- 5715
- Acronym
- UNPIN
- Status last verified
- Sep 2025
- First submitted
- 25 Apr 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data will be made available upon reasonable request to study PI following publication of full trial results.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture, a Pilot Randomized Control Trial (UNPIN Trial)
- ClinicalTrials.gov ID
- NCT05865327
- Acronym / sponsor ID
- UNPIN / 5715
- Conditions
- Rib Fractures, Rib Fracture Multiple, Rib; Fracture, With Flail Chest, Pain, Pain, Acute, Pain, Chronic
- Keywords
- Cryoneurolysis, Rib Fracture Pain, Intercostal Nerve Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 May 2023 (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.
Traumatic rib fractures (i.e., broken ribs caused by a physical injury) are common and very painful. They also often lead to serious complications, more time spent in hospital, and can even lead to death. Even after rib fractures have healed, they can lead to long-term pain and a lower quality of life.
A technology called cryoneurolysis, which acts to freeze nerves causing pain using a small tool which can turn very cold, is a promising new way to manage rib fracture pain. This study is a test with a small number of people to see if it is feasible to use this technology for patients with rib fractures. If this is successful, we will recruit more people for a larger study to see if cryoneurolysis, along with standard pain control techniques, is better at stopping pain, compared to just the normal techniques alone. Participants in our study will be asked to rate their pain, and record pain medications that they take for 3 months after their pain procedure.
Detailed description
More than 100,000 people a year suffer from traumatic rib fractures. Pain from rib fractures impairs the ability to inspire deeply and cough effectively, predisposing patients to severe, potentially life threatening complications and increased healthcare costs. For many patients, this pain can also persist long after the acute injury has healed, delaying recovery and reducing quality of life.
Current pain interventions, including multimodal analgesia and local anesthetic-based nerve blocks, are useful, but are limited by a short duration of effectiveness, and/or risk of complications. Cryoneurolysis (CN) is a new method to control pain which acts to freeze intercostal nerves (ICNs) associated with fractured ribs using a handheld device. This freezing action causes neurons to undergo Wallerian degeneration distally from the site of ablation and thus exhibit an extended but reversible block.
This study is a single-site, randomized, pilot study to assess the feasibility of recruitment, randomization, and protocol adherence of providing cryoneurolysis for patients with traumatic rib fractures. Secondary data from the pilot trial designed to assess the effectiveness of the intervention (pain scores, opioid usage, etc.) will be included in the analysis of the full trial if feasible. The objective of the full trial is to demonstrate that cryoneurolysis of ICN, in addition to standard analgesic practice, provides superior, prolonged analgesia.
Participants (individuals aged 18-85, with 3-8 unilateral traumatic rib fractures) will be randomized 1:1 in blocks of 4, stratified by number of rib fractures (> 4 or ≤4) and the presence/absence of flail segment, to receive the current standard of practice for rib fractures (multimodal analgesia and erector spinae plane (ESP) catheter infusion) with or without the addition of CN. Participants in the standard care group will receive a sham CN procedure to maintain blinding.
All participants (both groups) will receive standard of care analgesia. Specifically, an ultrasound-guided ESP catheter will be placed as per standard protocols. 20cc of 0.5% ropivacaine and 1% lidocaine will be injected through the catheter, followed by a basal infusion of 2 cc/hr of 0.2% ropivacaine (to maintain catheter patency) with an on demand patient controlled regional anesthesia (PCRA) dose of 10cc 0.2% ropivacaine available hourly until patient has met criteria for APS discharge or pain is controlled such that PCRA use is < 2 boluses over 12 hrs and NRS < 3 with deep breathing and coughing.
Standard multimodal analgesia including Tylenol 1000mg QID, Celebrex 200mg BID (or ketorolac 7.5 QID), Pregabalin 50mg BID, and/or PRN oral hydromorphone (1-4mg) will also be provided. Additional analgesics include intravenous ketamine at a dose of 0.1-0.2 mg/kg/hr of lean body weight in the event of consistent NRS pain scores > 6, and up to 0.05 mg/kg of intravenous midazolam for anxiolysis and 1mcg/kg of intravenous fentanyl for comfort during positioning, as required.
Participants will remain in the study for 3 months from the date of the block procedure. They will be followed daily while in hospital and using a pain diary following discharge (weekly pain scores and daily opioid usage). Additionally, follow-ups will be completed at 1h, 24h, 48h, 1 week, 1 month, and 3 months post block procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre, prospective, parallel, randomized, blinded (participant, data collectors/analysts) pilot feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Cryoneurolysis Group | Experimental | Procedure: CryoneurolysisIn addition to all standard of care analgesia treatments, CN will be performed on the ICN of each broken rib using the Iovera CN device and Generation 2 Iovera tip under ultrasound guidance. |
| Standard Care Group | Sham comparator | Procedure: Sham CryoneurolysisParticipants in the control group will receive all standard of care analgesia treatments as well as sham CN (i.e., application of device without skin puncture or activation of unit) to maintain participant blinding. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥18
- Unilateral traumatic rib fractures (3 to 8)
- Candidate for ESP block catheter
- Within 48hrs of admission to hospital
Key exclusion criteria (10 listed)
- Lack of patient consent; unlikely to comply with follow up
- Unable to use Patient Controlled Regional Analgesia (Ventilated/sedated patients or Moderate to severe traumatic brain injury)
- Chronic pain (opioid use > 30mg oral morphine equivalent per day)
- Substance use disorder
- CrCl < 50
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 |
|---|---|---|
| CryoneurolysisCryoneurolysis will be performed on the intercostal nerve associated with each fractured rib using a handheld cryoneurolysis machine (Iovera). Cryoneurolysis will consist of two 103 second cycles (includes cooling, ice ball formation and warming time) per rib fracture level. Ultrasound guidance will be used to identify appropriate rib fracture levels and to target the device tip in real time. All participants will also receive standard multimodal analgesia and ESP catheter infusion. | Procedure or surgery | Cryoneurolysis Group |
| Sham CryoneurolysisParticipants in the control group will receive sham CN (i.e., application of device without skin puncture or activation of unit) to maintain participant blinding. All participants will also receive standard multimodal analgesia and ESP catheter infusion. | Procedure or surgery | Standard Care Group |
Primary outcome
Number of participants randomized over an 8 month period
Time frame: Entire pilot study (approximately 8 months)
Goal of 3 participants per month for 8 months
Number of participants able to adhere to the protocol
Time frame: Entire pilot study (approximately 8 months + 3 month follow-up)
Goal of > 90%
Number of participants able to adhere to the follow-up
Time frame: 3 month follow-up
Goal of > 90%
Rate of Adverse events
Time frame: 3 month follow-up
Ensure no adverse events (short or long term) associated with CN
16 secondary outcomes
Pain Severity during deep inspiration 24 hours post ESP catheter placement
Time frame: 24 hours post placement of ESP catheter
Time to discontinuation of ESP catheter
Time frame: Until ESP catheter removal (usually < 7 days)
ESP catheter use
Time frame: Until ESP catheter removal (usually < 7 days)
Opioid consumption in hospital and after discharge
Time frame: Daily for 90 days after block placement
Pain Intensity at 1 and 3 months
Time frame: 1 and 3 month follow-ups
Oxygen requirements
Time frame: Pre-intervention, post intervention, then daily until discharge
Pulmonary Function Testing
Time frame: Pre-intervention, post intervention, then daily until discharge
Pulmonary Function Testing
Time frame: Pre-intervention, post intervention, then daily until discharge
Pulmonary Function Testing
Time frame: Pre-intervention, post intervention, then daily until discharge
Pulmonary Function Testing
Time frame: Pre-intervention, post intervention, then daily until discharge
Length of Stay in hospital
Time frame: Date of admission to date discharge
Length of Stay on acute pain service (APS)
Time frame: Date of admission to date of discharge from acute pain service
Time to achieve discharge criteria for isolated chest injury
Time frame: Date of admission until discharge criteria met
Patient satisfaction
Time frame: 48 post block procedure, and 1 week, 1 month and 3 month follow-ups
Incidence of chronic rib fracture pain
Time frame: 3 month follow-up
Adverse events
Time frame: until 3 month follow-up
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 12 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified participant-level data will be made available upon reasonable request to study PI following publication of full trial results.
Related trials for Rib Fractures
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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.
Ben Safa, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoneurolysis in people with Rib Fractures and Rib Fracture Multiple, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 4 inclusion and 10 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 12 Sep 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 Canada. 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. Some participants in this study may receive a placebo. 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 Ben Safa, MD (416-480-4864, ben.safa@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants randomized over an 8 month period (time frame: Entire pilot study (approximately 8 months)). The study lists 4 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 12 Sep 2025.