Lower Extremity Varicose VeinsNCT07907315
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
An observational study of Lower Extremity Varicose Veins and Radiofrequency Ablation, run by Chunshui He at 1 site in China.
Trial summary
This study compares two common heat-based procedures for treating varicose veins in the legs: radiofrequency ablation (RFA) and microwave ablation (MWA). Both treatments use heat to close off diseased veins, but they work differently-RFA heats through direct contact, while MWA uses microwave energy that spreads heat… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Extremity Varicose Veins, Radiofrequency Ablation, Microwave Ablation
- What is being tested?
- Radiofrequency ablation and Microwave Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Apr 2027
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be selected from adult patients presenting to the Department of Vascular Surgery at the Hospital of Chengdu University of Traditional Chinese Medicine with symptomatic lower extremity varicose veins. The study population will be recruited from adult patients presenting to the Department of Vascular Surgery at the Hospital of Chengdu University of Traditional Chinese Medicine with symptomatic lower extremity varicose veins. Eligible participants are individuals aged 18 to 75 years with ultrasound-confirmed great saphenous vein incompetence (reflux time >0.5 seconds), vein diameter of 4-12 mm, and CEAP clinical class C2 to C6. Exclusion criteria include prior ipsilateral venous interventions, deep vein thrombosis, arterial disease (ABI <0.7), severe organ dysfunction, pregnancy, chronic pain, or local anesthetic allergy. Consecutive eligible patients will be invited to participate until the target of 130 patients (65 per group) is reached.
Who may be able to join
- Age 18 to 75 years, male or female.
- Confirmed diagnosis of great saphenous vein (GSV) trunk reflux with a reflux time >0.5 seconds on lower extremity duplex ultrasound.
- CEAP clinical classification of C2 to C6 (inclusive).
- GSV trunk diameter (thigh segment) measuring 4 to 12 mm on pre-operative ultrasound.
- Planned to undergo endovenous thermal ablation treatment for varicose veins.
- Willing and able to provide written informed consent to participate in the study.
Who cannot join
- History of deep vein thrombosis (DVT) in the ipsilateral lower extremity.
- ior surgical stripping or endovenous ablation treatment on the ipsilateral GSV.
- Acute superficial venous thrombophlebitis in the ipsilateral lower extremity at the time of screening.
- Concurrent lower extremity arterial disease with an ankle-brachial index (ABI) <0.7.
- Pregnancy or currently breastfeeding.
- Known allergy or hypersensitivity to lidocaine, ropivacaine, or any amide-type local anesthetic agent.
Show all 14Show fewer
- Severe hepatic impairment (ALT or AST >3 times the upper limit of normal).
- Severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m²).
- Severe cardiac dysfunction (New York Heart Association Class III or IV) or uncontrolled cardiac arrhythmia.
- Coagulation abnormality (international normalized ratio >1.5 or platelet count <80 × 10⁹/L).
- Diagnosis of severe psychiatric disorder or cognitive impairment that would interfere with the ability to provide reliable Visual Analog Scale (VAS) pain scores.
- Planned bilateral simultaneous ablation procedure (both legs treated in the same session).
- Chronic pain syndrome or long-term use of analgesic medications (regular use for >3 months).
- Any other condition that, in the investigator's judgment, would make the patient unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
About this study
Official title: Comparison of Intraoperative Pain Scores Between Radiofrequency Ablation and Microwave Ablation for Lower Extremity Varicose Veins: A Prospective Single-Center Randomized Controlled Study
This study compares two common heat-based procedures for treating varicose veins in the legs: radiofrequency ablation (RFA) and microwave ablation (MWA). Both treatments use heat to close off diseased veins, but they work differently-RFA heats through direct contact, while MWA uses microwave energy that spreads heat more widely.
The main question is: Which procedure causes less pain during the surgery?
Read more
Participants will be randomly assigned to receive either RFA or MWA. Since the surgery is done under local anesthesia (not general anesthesia), patients remain awake throughout. We will measure their pain at four key moments:
When the needle is first inserted
Right after injecting the numbing fluid (tumescent anesthesia)
During the heat treatment itself
At the end of the entire procedure
We will also track how much numbing fluid is used, how long the procedure takes, and any side effects. Patients will be followed for 30 days after surgery to monitor recovery and satisfaction.
The goal is to find out whether one method is more comfortable for patients, and to identify which factors (such as age, vein size, or anxiety level) affect pain during each procedure. This will help doctors choose the best approach for each patient and improve the overall treatment experience.
- Conditions
- Lower Extremity Varicose Veins, Radiofrequency Ablation, Microwave Ablation, Pain Measurement
- Being tested
- Radiofrequency ablation, Microwave Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
Endovenous thermal ablation of the incompetent great saphenous vein (GSV) using radiofrequency energy. The procedure is performed under tumescent local anesthesia (TLA). The device delivers segmental radiofrequency energy (460 kHz) through a catheter placed within the GSV, heating the vein wall to approximately 120°C, causing collagen contraction and vein occlusion.
Microwave AblationProcedure or surgery
Endovenous thermal ablation of the incompetent great saphenous vein (GSV) using microwave energy. The procedure is performed under tumescent local anesthesia (TLA). The device delivers microwave energy (2450 MHz) through an antenna placed within the GSV, generating dielectric heating that causes thermal coagulation and vein closure.
| Study group | Role | What they receive |
|---|---|---|
| RFA Group | Not described Receives: Procedure: Radiofrequency ablation | |
| MWA Group | Not described Receives: Procedure: Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score at Tumescent Anesthesia Injection Completion (VAS-T2)
Pain intensity immediately after completion of tumescent local anesthesia (TLA) injection, assessed using the Visual Analog Scale (VAS). VAS is a clinical assessment tool that quantifies pain intensity using a linear scale approximately 10 centimeters long. The two ends of the scale are marked as "0" (no pain) and "10" (worst imaginable pain).The patient reports the most significant pain experienced during the entire TLA injection phase (from the first puncture to completion of injection).
Measured: Measured immediately after TLA injection is completed and ultrasound confirms satisfactory perivenous fluid infiltration (before ablation begins) - Intraoperative (Day 0)
Pain Score During Catheter Ablation (VAS-T3)
Pain intensity during the endovenous ablation phase, assessed using the Visual Analog Scale (VAS). The patient reports the most significant pain experienced during the entire ablation phase (from activation of the ablation device to completion of great saphenous vein trunk ablation).Visual Analog Scale (VAS): Minimum = 0, Maximum = 10. Higher scores indicate worse outcome (greater pain intensity). A score of 0 represents "no pain" and a score of 10 represents "worst imaginable pain."
Measured: Measured immediately after completion of GSV trunk ablation and withdrawal of the ablation catheter
Secondary outcomes (17)
Intraoperative Pain Trajectory (Group × Time Interaction)
Overall pattern of intraoperative pain across the four procedural time points, assessed to determine whether the pain trajectory differs between RFA and MWA groups. This is a composite measure derived by aggregating VAS scores from all four time points into a single repeated-measures model.VAS score (0-10 cm) analyzed as a repeated measure; reported as the group × time interaction effect (F-statistic and p-value) from a linear mixed effects model.
VAS scores from T1, T2, T3, and T4 will be combined using a linear mixed effects model (LMM) with fixed effects for group, time, and group × time interaction, and random effects for individual patients. The reported value is the group × time interaction effect, which indicates whether the pain trajectory differs between groups.
Measured: Assessed at four time points: T1 (immediately after sheath placement), T2 (immediately after TLA injection), T3 (immediately after ablation completion), and T4 (immediately after procedure completion)
TLA Total Injection Volume
Total volume of tumescent local anesthesia (TLA) solution injected during the procedure.Milliliters (mL)
Measured: Recorded during the TLA injection phase
RFA Ablation Energy Parameters
Device-specific energy parameters for the RFA group, including temperature achieved.Temperature (°C)
Measured: Intraoperative (Day 0); recorded during the ablation phase
MWA Ablation Energy Parameters
Device-specific energy parameters for the MWA group, including power output .Power (Watts)
Measured: Recorded during the ablation phase
Postoperative Pain at 2 Hours
Pain intensity at rest in the treated leg at 2 hours after procedure completion.VAS score (0-10 cm)
Measured: Postoperative 2 hours
Postoperative Pain at 24 Hours
Pain intensity at rest in the treated leg at 24 hours after procedure completion.VAS score (0-10 cm),Visual Analog Scale (VAS): Minimum = 0, Maximum = 10. Higher scores indicate worse outcome (greater pain intensity)
Measured: Postoperative 24 hours (Day 1)
Postoperative Pain at 7 Days
Pain intensity at rest in the treated leg at 7 days after procedure completion.VAS score (0-10 cm)
Measured: Postoperative 7 days (Day 7)
Postoperative Pain at 30 Days
Pain intensity at rest in the treated leg at 30 days after procedure completion.VAS score (0-10 cm),VAS: Minimum = 0, Maximum = 10. Higher scores indicate worse outcome (greater pain intensity)
Measured: Postoperative 30 days (Day 30)
Venous Clinical Severity Score (VCSS) at Baseline
Disease-specific clinical severity assessed using the Venous Clinical Severity Score (VCSS) before treatment.VCSS score (0-30)
Measured: Baseline (preoperative, within 7 days before surgery)
Venous Clinical Severity Score (VCSS) at 30 Days
Disease-specific clinical severity assessed using the Venous Clinical Severity Score (VCSS) at 30 days after treatment.VCSS is a standardized tool for assessing the severity of lower extremity venous disease. It consists of 10 items (pain, varicose veins, edema, pigmentation, inflammation, induration, ulcer number/size/duration, and compression therapy). Each item is scored from 0 to 3, with a total score ranging from 0 to 30. Higher scores indicate more severe clinical symptoms.
Measured: Postoperative 30 days (Day 30)
Change in Venous Clinical Severity Score (ΔVCSS)
Change in disease-specific clinical severity from baseline to 30 days after treatment. This is a derived composite measure calculated by subtracting the 30-day VCSS from the baseline VCSS.VCSS score change (baseline VCSS minus 30-day VCSS)
Measured: Baseline to postoperative 30 days
Incidence of Adverse Events
Incidence and severity of all procedure-related adverse events from intraoperative period through 30 days post-procedure.Count and percentage of patients with ≥1 adverse event
Measured: Intraoperative through postoperative 30 days
Factors Influencing Intraoperative Pain - Univariable Analysis
Exploratory analysis to identify patient, anatomical, and procedural factors associated with pain at each intraoperative time point.Correlation coefficient (r or ρ) or regression coefficient (β) with 95% CI.Each candidate factor is tested individually against each VAS outcome (T1-T4). Results are reported as point estimates with 95% confidence intervals.
Measured: Intraoperative (Day 0); using data from all four time points (T1, T2, T3, T4)
Factors Influencing Intraoperative Pain - Multivariable Analysis
Exploratory multivariable analysis to identify independent factors influencing pain at the two core time points (VAS-T2 and VAS-T3).Regression coefficient (β) with 95% CI.Separate multivariable linear regression models for VAS-T2 and VAS-T3. Each model includes group assignment, prespecified core variables, and univariable significant factors.
Measured: Intraoperative (Day 0); using data from T2 (TLA injection) and T3 (ablation)
Effect Modification by Patient/Procedural Factors (Group × Factor Interaction)
Exploratory analysis to determine whether the effect of RFA vs. MWA on pain is modified by patient, anatomical, or procedural factors.Interaction effect (β for interaction term) with 95% CI and p-value.Each interaction term (group × factor) tested individually in separate regression models that include both main effects and the interaction.
Measured: Intraoperative (Day 0); using data from T2 (TLA injection) and T3 (ablation)
RFA Ablation Energy Parameters
Device-specific energy parameters for the RFA group, including number of ablation segments and temperature achieved.Number of segments (count); temperature (°C)
Measured: Intraoperative (Day 0); recorded during the ablation phase
MWA Ablation Energy Parameters
Device-specific energy parameters for the MWA group, including power output .Power (Watts)
Measured: Intraoperative (Day 0); recorded during the ablation phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Sep 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Varicose VeinsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chunshui He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chunshui He, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907315
- Sponsor's protocol ID
- ChengduUTCM XGWK
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative Pain Scores Between Radiofrequency Ablation and Microwave Ablation for Lower Extremity Varicose Veins: A Prospective Single-Center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07907315
- Acronym / sponsor ID
- ChengduUTCM XGWK
- Conditions
- Lower Extremity Varicose Veins, Radiofrequency Ablation, Microwave Ablation, Pain Measurement
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Chunshui HeUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 30 Oct 2026 (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 compares two common heat-based procedures for treating varicose veins in the legs: radiofrequency ablation (RFA) and microwave ablation (MWA). Both treatments use heat to close off diseased veins, but they work differently-RFA heats through direct contact, while MWA uses microwave energy that spreads heat more widely.
The main question is: Which procedure causes less pain during the surgery?
Participants will be randomly assigned to receive either RFA or MWA. Since the surgery is done under local anesthesia (not general anesthesia), patients remain awake throughout. We will measure their pain at four key moments:
When the needle is first inserted
Right after injecting the numbing fluid (tumescent anesthesia)
During the heat treatment itself
At the end of the entire procedure
We will also track how much numbing fluid is used, how long the procedure takes, and any side effects. Patients will be followed for 30 days after surgery to monitor recovery and satisfaction.
The goal is to find out whether one method is more comfortable for patients, and to identify which factors (such as age, vein size, or anxiety level) affect pain during each procedure. This will help doctors choose the best approach for each patient and improve the overall treatment experience.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA Group | – | Procedure: Radiofrequency ablation |
| MWA Group | – | Procedure: Microwave Ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from adult patients presenting to the Department of Vascular Surgery at the Hospital of Chengdu University of Traditional Chinese Medicine with symptomatic lower extremity varicose veins. The study population will be recruited from adult patients presenting to the Department of Vascular Surgery at the Hospital of Chengdu University of Traditional Chinese Medicine with symptomatic lower extremity varicose veins. Eligible participants are individuals aged 18 to 75 years with ultrasound-confirmed great saphenous vein incompetence (reflux time >0.5 seconds), vein diameter of 4-12 mm, and CEAP clinical class C2 to C6. Exclusion criteria include prior ipsilateral venous interventions, deep vein thrombosis, arterial disease (ABI <0.7), severe organ dysfunction, pregnancy, chronic pain, or local anesthetic allergy. Consecutive eligible patients will be invited to participate until the target of 130 patients (65 per group) is reached.
Key inclusion criteria (6 listed)
- Age 18 to 75 years, male or female.
- Confirmed diagnosis of great saphenous vein (GSV) trunk reflux with a reflux time >0.5 seconds on lower extremity duplex ultrasound.
- CEAP clinical classification of C2 to C6 (inclusive).
- GSV trunk diameter (thigh segment) measuring 4 to 12 mm on pre-operative ultrasound.
- Planned to undergo endovenous thermal ablation treatment for varicose veins.
Key exclusion criteria (14 listed)
- History of deep vein thrombosis (DVT) in the ipsilateral lower extremity.
- ior surgical stripping or endovenous ablation treatment on the ipsilateral GSV.
- Acute superficial venous thrombophlebitis in the ipsilateral lower extremity at the time of screening.
- Concurrent lower extremity arterial disease with an ankle-brachial index (ABI) <0.7.
- Pregnancy or currently breastfeeding.
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 |
|---|---|---|
| Radiofrequency ablationEndovenous thermal ablation of the incompetent great saphenous vein (GSV) using radiofrequency energy. The procedure is performed under tumescent local anesthesia (TLA). The device delivers segmental radiofrequency energy (460 kHz) through a catheter placed within the GSV, heating the vein wall to approximately 120°C, causing collagen contraction and vein occlusion. | Procedure or surgery | RFA Group |
| Microwave AblationEndovenous thermal ablation of the incompetent great saphenous vein (GSV) using microwave energy. The procedure is performed under tumescent local anesthesia (TLA). The device delivers microwave energy (2450 MHz) through an antenna placed within the GSV, generating dielectric heating that causes thermal coagulation and vein closure. | Procedure or surgery | MWA Group |
Primary outcome
Pain Score at Tumescent Anesthesia Injection Completion (VAS-T2)
Time frame: Measured immediately after TLA injection is completed and ultrasound confirms satisfactory perivenous fluid infiltration (before ablation begins) - Intraoperative (Day 0)
Pain intensity immediately after completion of tumescent local anesthesia (TLA) injection, assessed using the Visual Analog Scale (VAS). VAS is a clinical assessment tool that quantifies pain intensity using a linear scale approximately 10 centimeters long. The two ends of the scale are marked as "0" (no pain) and "10" (worst imaginable pain).The patient reports the most significant pain experienced during the entire TLA injection phase (from the first puncture to completion of injection).
Pain Score During Catheter Ablation (VAS-T3)
Time frame: Measured immediately after completion of GSV trunk ablation and withdrawal of the ablation catheter
Pain intensity during the endovenous ablation phase, assessed using the Visual Analog Scale (VAS). The patient reports the most significant pain experienced during the entire ablation phase (from activation of the ablation device to completion of great saphenous vein trunk ablation).Visual Analog Scale (VAS): Minimum = 0, Maximum = 10. Higher scores indicate worse outcome (greater pain intensity). A score of 0 represents "no pain" and a score of 10 represents "worst imaginable pain."
17 secondary outcomes
Intraoperative Pain Trajectory (Group × Time Interaction)
Time frame: Assessed at four time points: T1 (immediately after sheath placement), T2 (immediately after TLA injection), T3 (immediately after ablation completion), and T4 (immediately after procedure completion)
TLA Total Injection Volume
Time frame: Recorded during the TLA injection phase
RFA Ablation Energy Parameters
Time frame: Intraoperative (Day 0); recorded during the ablation phase
MWA Ablation Energy Parameters
Time frame: Recorded during the ablation phase
Postoperative Pain at 2 Hours
Time frame: Postoperative 2 hours
Postoperative Pain at 24 Hours
Time frame: Postoperative 24 hours (Day 1)
Postoperative Pain at 7 Days
Time frame: Postoperative 7 days (Day 7)
Postoperative Pain at 30 Days
Time frame: Postoperative 30 days (Day 30)
Venous Clinical Severity Score (VCSS) at Baseline
Time frame: Baseline (preoperative, within 7 days before surgery)
Venous Clinical Severity Score (VCSS) at 30 Days
Time frame: Postoperative 30 days (Day 30)
Change in Venous Clinical Severity Score (ΔVCSS)
Time frame: Baseline to postoperative 30 days
Incidence of Adverse Events
Time frame: Intraoperative through postoperative 30 days
Factors Influencing Intraoperative Pain - Univariable Analysis
Time frame: Intraoperative (Day 0); using data from all four time points (T1, T2, T3, T4)
Factors Influencing Intraoperative Pain - Multivariable Analysis
Time frame: Intraoperative (Day 0); using data from T2 (TLA injection) and T3 (ablation)
Effect Modification by Patient/Procedural Factors (Group × Factor Interaction)
Time frame: Intraoperative (Day 0); using data from T2 (TLA injection) and T3 (ablation)
RFA Ablation Energy Parameters
Time frame: Intraoperative (Day 0); recorded during the ablation phase
MWA Ablation Energy Parameters
Time frame: Intraoperative (Day 0); recorded during the ablation phase
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 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Extremity Varicose Veins and Radiofrequency Ablation, run by Chunshui He at 1 site in China.
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 6 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score at Tumescent Anesthesia Injection Completion (VAS-T2) (time frame: Measured immediately after TLA injection is completed and ultrasound confirms satisfactory perivenous fluid infiltration (before ablation begins) - Intraoperative (Day 0)). The study lists 2 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 30 Oct 2026.