CholecystitisIBPMNCT07473687
Feasibility Study of Non-Contact Imaging-Based Physiological Monitoring in the Operating Room
An observational study of Cholecystitis and Liver Neoplasms, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study aims to evaluate the feasibility and accuracy of a non-contact, camera-based physiological monitoring technology in a perioperative setting (including anesthesia induction, surgery, and recovery).Conventional vital sign monitoring tools-such as ECG leads, blood pressure cuffs, and pulse oximeters-require… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Liver Neoplasms, Cholelithiasis
- What is being tested?
- Non-contact rPPG software
- Type of treatment
- Medical device
- How many people
- 315 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jan 2026to 30 Jun 2030
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical patients undergoing anesthesia and surgery at Taipei Veterans General Hospital who meet the specified inclusion and exclusion criteria.
Who may be able to join
- Patients aged >18 years.
- Patients scheduled to undergo surgical procedures under general anesthesia.
- American Society of Anesthesiologists (ASA) Physical Status I, II, or III.
Who cannot join
- Patients aged < 18 years.
- Pregnant patients.
- Patients whose facial images cannot be captured or recognized (e.g., due to surgical drapes, severe edema, or major trauma).
- Patients who refuse to participate or have not signed the informed consent form.
- Other cases deemed unsuitable for the study by the clinical physician or anesthesiologist.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, 11217
Hui-Hsuan Ke, +886-939-196-809, kehuihsuan0221@gmail.com
About this study
This study aims to evaluate the feasibility and accuracy of a non-contact, camera-based physiological monitoring technology in a perioperative setting (including anesthesia induction, surgery, and recovery).Conventional vital sign monitoring tools-such as ECG leads, blood pressure cuffs, and pulse oximeters-require direct skin contact, which may pose risks of cross-infection or skin injury in vulnerable populations (e.g., newborns or elderly patients). This research utilizes remote Photoplethysmography (rPPG) technology to estimate vital signs, including heart rate, blood pressure, and blood oxygen saturation (SpO2), by analyzing facial video captured via standard camera devices (Logitech C930, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra).The primary goal is to assess the consistency and stability of this non-contact system compared to clinical gold-standard monitors (Masimo Root, SedLine O3, and Radical-7) during actual surgical procedures. The findings will serve as a foundation for developing non-invasive, supplementary monitoring tools in dynamic clinical environments.
Read the detailed description
Background and Rationale:
Perioperative vital sign monitoring is crucial for patient safety. However, current standard-of-care tools are predominantly contact-based or invasive. These devices can cause discomfort, limit patient mobility, and potentially damage fragile skin. While various non-contact sensing technologies (e.g., radar, thermal imaging) have been researched, high costs and poor adaptability to dynamic clinical settings have limited their routine use. Our team has previously validated a camera-based rPPG algorithm in clinical environments; this study seeks to further evaluate its feasibility within the rigorous conditions of an operating room (OR).
Study Objectives:
To evaluate the accuracy and consistency of a non-contact video monitoring system in measuring heart rate, blood pressure, and SpO2 across different surgical phases (pre-operative, intra-operative, and post-operative).To optimize algorithms using multi-point clinical data to enhance system robustness in dynamic surgical environments. To explore the potential of rPPG technology as a supplementary or alternative monitoring solution for patients unsuitable for traditional contact-based sensors.
Methodology:
This is a feasibility study conducted in a perioperative clinical environment. Participants will undergo simultaneous monitoring by two systems without interference with routine medical care:
- Investigational Device (Non-contact): A software module utilizing rPPG technology installed on multiple platforms (Logitech C930 with Windows Laptop, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra). These devices capture facial video via front-facing cameras to calculate physiological parameters non-invasively.
- Reference Standard (Clinical Monitors): The Masimo Root monitoring platform, equipped with SedLine O3 regional oximetry and Radical-7 pulse oximetry, will provide the benchmark physiological data.
Data Analysis:
The estimated physiological parameters from the non-contact software will be compared with the synchronized data from the Masimo Root system. Statistical analysis will focus on the correlation and limits of agreement between the two methods to determine the technical feasibility for future clinical translation.
- Conditions
- Cholecystitis, Liver Neoplasms, Cholelithiasis, Inguinal Hernia
- Being tested
- Non-contact rPPG software
- Keywords
- General anesthesia, Intraoperative monitoring, Camera-based monitor, Non-contact Physiological Monitoring, Total Extraperitoneal Approach (TEP), Remote Sensing, Perioperative Care
- Medical subject headings
- Cholecystitis, Liver Neoplasms, Cholelithiasis, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contact rPPG softwareDevice
A non-invasive, video-based software utilizing remote Photoplethysmography (rPPG) technology to estimate heart rate, blood pressure, and SpO2 by analyzing facial video captured via camera-enabled devices.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Monitoring Group | Surgical patients who will be monitored simultaneously using both the investigational non-contact rPPG software (installed on laptop and mobile devices) and standard clinical monitoring systems (Masimo Root, SedLine O3, and Radical-7) across different surgical phases. Receives: Device: Non-contact rPPG software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Heart Rate (HR) monitoring
The success rate of non-contact HR measurement using the rPPG software compared to the reference values from the Masimo Root clinical monitoring platform. A "success" is defined as an absolute error within +/- 3 bpm.
Unit of Measure: Percentage of successful measurements (%)
Measured: From anesthesia induction to recovery (approximately 2-6 hours).
Success rate of Systolic Blood Pressure (SBP) monitoring
The success rate of non-contact SBP measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 12 mmHg.
Unit of Measure: Percentage of successful measurements (%)
Measured: From anesthesia induction to recovery (approximately 2-6 hours).
Success rate of Diastolic Blood Pressure (DBP) monitoring
The success rate of non-contact DBP measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 10 mmHg.
Unit of Measure: Percentage of successful measurements (%)
Measured: From anesthesia induction to recovery (approximately 2-6 hours).
Success rate of Oxygen Saturation (SpO2) monitoring
The success rate of non-contact SpO2 measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 8% (when SpO2 >/= 80%) or +/- 15% (when SpO2 < 80%).
Unit of Measure: Percentage of successful measurements (%)
Measured: From anesthesia induction to recovery (approximately 2-6 hours).
Secondary outcomes (2)
Mean Absolute Error (MAE) of Heart Rate (HR) across hardware platforms
Evaluation of the Heart Rate measurement consistency among three devices (Logitech C930, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra) compared to the Masimo Root monitor. The measurement tool is the rPPG software. Consistency will be assessed by calculating the Mean Absolute Error (MAE) of heart rate.
Unit of Measure： Beats per minute (bpm)
Measured: During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).
Mean Absolute Error (MAE) of Blood Pressure (SBP and DBP) across hardware platforms
Evaluation of the Systolic and Diastolic Blood Pressure measurement consistency among three devices (Logitech C930, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra) compared to the Masimo Root monitor. The measurement tool is the rPPG software. Consistency will be assessed by calculating the Mean Absolute Error (MAE) of blood pressure.
Unit of Measure： mmHg
Measured: During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start8 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hui-Hsuan Ke, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473687
- Sponsor's protocol ID
- 2025-07-019CC
- Acronym
- IBPM
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared at this time to protect proprietary algorithmic information and ongoing technical development related to the monitoring software.
Publications
Fujimori S. Gastric acid level of humans must decrease in the future. World J Gastroenterol. 2020 Nov 21;26(43):6706-6709. doi: 10.3748/wjg.v26.i43.6706.
PubMed 33268958Greenstein VC, Eggers HM, Hood DC. Multifocal visual evoked potential and automated perimetry abnormalities in strabismic amblyopes. J AAPOS. 2008 Feb;12(1):11-7. doi: 10.1016/j.jaapos.2007.04.017. Epub 2007 Jul 24.
PubMed 17651996Xing L, Dai W, Zhang Y. Scheimpflug Camera-Based Technique for Multi-Point Displacement Monitoring of Bridges. Sensors (Basel). 2022 May 27;22(11):4093. doi: 10.3390/s22114093.
PubMed 35684714Garcia-Fontana C, Corral Lugo A, Krell T. Specificity of the CheR2 methyltransferase in Pseudomonas aeruginosa is directed by a C-terminal pentapeptide in the McpB chemoreceptor. Sci Signal. 2014 Apr 8;7(320):ra34. doi: 10.1126/scisignal.2004849.
PubMed 24714571Mismetti P, Rivron-Guillot K, Moulin N. [Vena cava filters and treatment of venous thromboembolism in cancer patients]. Pathol Biol (Paris). 2008 Jun;56(4):229-32. doi: 10.1016/j.patbio.2008.03.002. Epub 2008 May 5. French.
PubMed 18456434Wallach JB, McGarry T, Torres J. Lymphangitic metastasis of recurrent renal cell carcinoma to the contralateral lung causing lymphangitic carcinomatosis and respiratory symptoms. Curr Oncol. 2011 Jan;18(1):e35-7. doi: 10.3747/co.v18i1.647.
PubMed 21331270Lee KJ, Liu S, Parmigiani F, Ibsen M, Petropoulos P, Gallo K, Richardson DJ. OTDM to WDM format conversion based on quadratic cascading in a periodically poled lithium niobate waveguide. Opt Express. 2010 May 10;18(10):10282-8. doi: 10.1364/OE.18.010282.
PubMed 20588881Wada M, Hara H, Nakamura M. A change in the pattern of vasospasm after stenting in a patient with vasospastic angina. Heart Vessels. 2006 Nov;21(6):388-91. doi: 10.1007/s00380-006-0920-6. Epub 2006 Nov 27.
PubMed 17143717
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Non-Contact Imaging-Based Physiological Monitoring in the Operating Room
- ClinicalTrials.gov ID
- NCT07473687
- Acronym / sponsor ID
- IBPM / 2025-07-019CC
- Conditions
- Cholecystitis, Liver Neoplasms, Cholelithiasis, Inguinal Hernia
- Keywords
- General anesthesia, Intraoperative monitoring, Camera-based monitor, Non-contact Physiological Monitoring, Total Extraperitoneal Approach (TEP), Remote Sensing, Perioperative Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 16 Mar 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 aims to evaluate the feasibility and accuracy of a non-contact, camera-based physiological monitoring technology in a perioperative setting (including anesthesia induction, surgery, and recovery).Conventional vital sign monitoring tools-such as ECG leads, blood pressure cuffs, and pulse oximeters-require direct skin contact, which may pose risks of cross-infection or skin injury in vulnerable populations (e.g., newborns or elderly patients). This research utilizes remote Photoplethysmography (rPPG) technology to estimate vital signs, including heart rate, blood pressure, and blood oxygen saturation (SpO2), by analyzing facial video captured via standard camera devices (Logitech C930, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra).The primary goal is to assess the consistency and stability of this non-contact system compared to clinical gold-standard monitors (Masimo Root, SedLine O3, and Radical-7) during actual surgical procedures. The findings will serve as a foundation for developing non-invasive, supplementary monitoring tools in dynamic clinical environments.
Detailed description
Background and Rationale:
Perioperative vital sign monitoring is crucial for patient safety. However, current standard-of-care tools are predominantly contact-based or invasive. These devices can cause discomfort, limit patient mobility, and potentially damage fragile skin. While various non-contact sensing technologies (e.g., radar, thermal imaging) have been researched, high costs and poor adaptability to dynamic clinical settings have limited their routine use. Our team has previously validated a camera-based rPPG algorithm in clinical environments; this study seeks to further evaluate its feasibility within the rigorous conditions of an operating room (OR).
Study Objectives:
To evaluate the accuracy and consistency of a non-contact video monitoring system in measuring heart rate, blood pressure, and SpO2 across different surgical phases (pre-operative, intra-operative, and post-operative).To optimize algorithms using multi-point clinical data to enhance system robustness in dynamic surgical environments. To explore the potential of rPPG technology as a supplementary or alternative monitoring solution for patients unsuitable for traditional contact-based sensors.
Methodology:
This is a feasibility study conducted in a perioperative clinical environment. Participants will undergo simultaneous monitoring by two systems without interference with routine medical care:
- Investigational Device (Non-contact): A software module utilizing rPPG technology installed on multiple platforms (Logitech C930 with Windows Laptop, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra). These devices capture facial video via front-facing cameras to calculate physiological parameters non-invasively.
- Reference Standard (Clinical Monitors): The Masimo Root monitoring platform, equipped with SedLine O3 regional oximetry and Radical-7 pulse oximetry, will provide the benchmark physiological data.
Data Analysis:
The estimated physiological parameters from the non-contact software will be compared with the synchronized data from the Masimo Root system. Statistical analysis will focus on the correlation and limits of agreement between the two methods to determine the technical feasibility for future clinical translation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perioperative Monitoring Group | – | Device: Non-contact rPPG softwareSurgical patients who will be monitored simultaneously using both the investigational non-contact rPPG software (installed on laptop and mobile devices) and standard clinical monitoring systems (Masimo Root, SedLine O3, and Radical-7) across different surgical phases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients undergoing anesthesia and surgery at Taipei Veterans General Hospital who meet the specified inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Patients aged >18 years.
- Patients scheduled to undergo surgical procedures under general anesthesia.
- American Society of Anesthesiologists (ASA) Physical Status I, II, or III.
Key exclusion criteria (5 listed)
- Patients aged < 18 years.
- Pregnant patients.
- Patients whose facial images cannot be captured or recognized (e.g., due to surgical drapes, severe edema, or major trauma).
- Patients who refuse to participate or have not signed the informed consent form.
- Other cases deemed unsuitable for the study by the clinical physician or anesthesiologist.
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 |
|---|---|---|
| Non-contact rPPG softwareA non-invasive, video-based software utilizing remote Photoplethysmography (rPPG) technology to estimate heart rate, blood pressure, and SpO2 by analyzing facial video captured via camera-enabled devices. | Device | Perioperative Monitoring Group |
Primary outcome
Accuracy of Heart Rate (HR) monitoring
Time frame: From anesthesia induction to recovery (approximately 2-6 hours).
The success rate of non-contact HR measurement using the rPPG software compared to the reference values from the Masimo Root clinical monitoring platform. A "success" is defined as an absolute error within +/- 3 bpm. Unit of Measure: Percentage of successful measurements (%)
Success rate of Systolic Blood Pressure (SBP) monitoring
Time frame: From anesthesia induction to recovery (approximately 2-6 hours).
The success rate of non-contact SBP measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 12 mmHg. Unit of Measure: Percentage of successful measurements (%)
Success rate of Diastolic Blood Pressure (DBP) monitoring
Time frame: From anesthesia induction to recovery (approximately 2-6 hours).
The success rate of non-contact DBP measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 10 mmHg. Unit of Measure: Percentage of successful measurements (%)
Success rate of Oxygen Saturation (SpO2) monitoring
Time frame: From anesthesia induction to recovery (approximately 2-6 hours).
The success rate of non-contact SpO2 measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 8% (when SpO2 >/= 80%) or +/- 15% (when SpO2 < 80%). Unit of Measure: Percentage of successful measurements (%)
2 secondary outcomes
Mean Absolute Error (MAE) of Heart Rate (HR) across hardware platforms
Time frame: During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).
Mean Absolute Error (MAE) of Blood Pressure (SBP and DBP) across hardware platforms
Time frame: During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).
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 16 Mar 2026.
- Background: PubMed 33268958Fujimori S. Gastric acid level of humans must decrease in the future. World J Gastroenterol. 2020 Nov 21;26(43):6706-6709. doi: 10.3748/wjg.v26.i43.6706.
- Background: PubMed 17651996Greenstein VC, Eggers HM, Hood DC. Multifocal visual evoked potential and automated perimetry abnormalities in strabismic amblyopes. J AAPOS. 2008 Feb;12(1):11-7. doi: 10.1016/j.jaapos.2007.04.017. Epub 2007 Jul 24.
- Background: PubMed 35684714Xing L, Dai W, Zhang Y. Scheimpflug Camera-Based Technique for Multi-Point Displacement Monitoring of Bridges. Sensors (Basel). 2022 May 27;22(11):4093. doi: 10.3390/s22114093.
- Background: PubMed 24714571Garcia-Fontana C, Corral Lugo A, Krell T. Specificity of the CheR2 methyltransferase in Pseudomonas aeruginosa is directed by a C-terminal pentapeptide in the McpB chemoreceptor. Sci Signal. 2014 Apr 8;7(320):ra34. doi: 10.1126/scisignal.2004849.
- Background: PubMed 18456434Mismetti P, Rivron-Guillot K, Moulin N. [Vena cava filters and treatment of venous thromboembolism in cancer patients]. Pathol Biol (Paris). 2008 Jun;56(4):229-32. doi: 10.1016/j.patbio.2008.03.002. Epub 2008 May 5. French.
- Background: PubMed 21331270Wallach JB, McGarry T, Torres J. Lymphangitic metastasis of recurrent renal cell carcinoma to the contralateral lung causing lymphangitic carcinomatosis and respiratory symptoms. Curr Oncol. 2011 Jan;18(1):e35-7. doi: 10.3747/co.v18i1.647.
- Background: PubMed 20588881Lee KJ, Liu S, Parmigiani F, Ibsen M, Petropoulos P, Gallo K, Richardson DJ. OTDM to WDM format conversion based on quadratic cascading in a periodically poled lithium niobate waveguide. Opt Express. 2010 May 10;18(10):10282-8. doi: 10.1364/OE.18.010282.
- Background: PubMed 17143717Wada M, Hara H, Nakamura M. A change in the pattern of vasospasm after stenting in a patient with vasospastic angina. Heart Vessels. 2006 Nov;21(6):388-91. doi: 10.1007/s00380-006-0920-6. Epub 2006 Nov 27.
- Institutional Review Board of Taipei Veterans General HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared at this time to protect proprietary algorithmic information and ongoing technical development related to the monitoring software.
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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.
Hui-Hsuan Ke principal investigator
Taipei Veterans General Hospital, Taiwan
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 Cholecystitis and Liver Neoplasms, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 3 inclusion and 5 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 16 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 1 site in Taiwan. 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 Hui-Hsuan Ke (+886-939-196-809, kehuihsuan0221@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Heart Rate (HR) monitoring (time frame: From anesthesia induction to recovery (approximately 2-6 hours).). 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?
On the ClinicalTrials.gov record for NCT07473687, which also lists 8 linked publications.
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 16 Mar 2026.