Postoperative DeliriumNCT06445153
Digitalized Clinical Decision Support for the Prevention of Postoperative Delirium (POD)
A study testing Intervention with clinical decision support system in people with Postoperative Delirium, run by Charite University, Berlin, Germany at 4 sites in Germany.
Trial summary
The project aims to improve patient safety, reduce barriers to the implementation of current guideline recommendations, reduce workload in clinics, increase efficiency in work processes and close gaps in care. Subprojects regarding delirium are implementes as well. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Intervention with clinical decision support system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 844 participants
- Where
- 4 sitesGermany
- Study dates
- 3 Jun 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70 years
- Male and female patients
- Patients who are insured through statutory health insurance
- Patients capable of giving consent for inclusion: by the patient, preoperatively
- Patients under guardianship for inclusion: written declaration of consent by guardian
- Operation (elective)
Show all 10Show fewer
- Age ≥ 18 years
- Male and female relatives
- Relatives capable of giving consent for inclusion
- All inpatients ≥ 18 years of age who have undergone delirium screening with a validated delirium screening instrument
Who cannot join
- Insufficient language skills
- Moribund patients
- Study relatives
- Insufficient language skills
- No consent for data entry
- Substudy of the Charité - University Berlin:
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Institut für Anästhesiologie und Schmerztherapie-Herz- und Diabeteszentrum NRW- Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, Bochum, 32545
Department of Anaesthesiolgy and Intensive Care Medicine CCM/CVK, Charite- University Berlin
Berlin, 13355
CARITAS Klinik Maria Heimsuchung
Berlin
Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
Berlin
About this study
The project aims to improve patient safety, reduce barriers to the implementation of current guideline recommendations, reduce workload in clinics, increase efficiency in work processes and close gaps in care. Subprojects regarding delirium are implementes as well.
Read the detailed description
Postoperative delirium (POD) is the most common post-operative complication in the 70+ age group, affecting approximately fifteen percent of elderly patients. POD is characterized by impaired attention, awareness, and cognitive function. Both patients and their families are severely affected by the effects of this condition. While symptoms of POD occur during hospitalization, they have a critical impact on post-hospitalization quality of life, dependency on long-term care, and life expectancy.
The overarching goal of the Digi-POD project consortium is to develop a digital decision support system that makes current evidence-based guideline recommendations for POD machine-readable and allows automated, real-time validation against clinical data.
Sub-projects such as a point prevalence analysis on the incidence of delirium on 2 days at the Charité and a staff survey conducted by Aktionsbündnis Patientensicherheit e.V. in all study centers accompany this study.
Further substudies initiated by Charité Universitätsmedizin Berlin:
Two substudies (one feasibility study and one acceptance study) will be conducted using the prototype of the Clinical Brain Protection (CBP) application in Digi-POD patients at Charité.
Interviews and a review of project documentation to analyze obstacles and solution strategies for implementing data security/information security will be organized by Fraunhofer Fokus. The results will be incorporated into the Data Security project report.
- Conditions
- Postoperative Delirium
- Being tested
- Intervention with clinical decision support system
- Keywords
- Clinical decision support system, Delirium risk factors, recommendations, surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with clinical decision support systemOther
To this phase, patient data is automated and systematically analyzed in order to derive decision support based on current evidence and make it available to Digi-POD users (patients, relatives, nursing staff, doctors, other healthcare professionals).
| Study group | Role | What they receive |
|---|---|---|
| Control phase | No intervention | Control phase: in this phase, all study patients receive the standard therapy of the respective study center. |
| Intervention phase | Experimental | In this phase, the intervention with Digi-POD is made available as Clinical Decision Support System. The intervention consists of providing patients, relatives and caregivers with Digi-POD decision support for the prevention of delirium and treatment decisions for delirium in accordance with the recommendations from the guidelines in addition to the standard therapy of the respective study center. Receives: Other: Intervention with clinical decision support system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guideline adherence
Guideline adherence: proportion of guideline recommendations fulfilled per patient in the first five postoperative days. The guideline adherence rate up to postoperative day 5 (or earlier if the patient has already been discharged) is calculated as a simple division: Number of recommendations fulfilled by number of all recommendations (N=6). A guideline adherence rate of at least 4 out of 6 points (67%) per patient is considered clinically sufficient.
Measured: Up to five days
Postperative delirium- free days
Number of postoperative delirium- free days within 5 days postoperatively per patient.
Measured: Up to five days
Secondary outcomes (50)
Causes of delirium
Causes of postoperative delirium- within 7 days postoperatively per patient.
Measured: Up to seven days
Changes of Electroencephalography
Signals are measured by Electroencephalography Monitor.
Measured: Participants will be followed up until the end of the operation, an expected average of 60 minutes
Blood pressure
Blood pressure is measured in millimeters of mercury. Drop in blood pressure, Digi-POD cutoff RR systolic below 20% of baseline from start of surgery to discharge ICU.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Pulse
Heart rate (or pulse rate) is the frequency of the heartbeat measured by the number of contractions of the heart per minute.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Heart rhythm
Heart rhythm is measured by an electrocardiogram used to evaluate heart frequencies.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Heart rate
Heart rate is measured by an electrocardiogram used to evaluate the heart. Heart rate drop Digi-POD cutoff below 50 bpm from start of surgery to discharge ICU.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Oxygen saturation
Oxygen saturation is measured by pulse oximetry.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Amount of dexmedetomidine
If dexmedetomidine is administered by the attending physician, the information from the patient's dexmedetomidine medication chart is recorded.
Measured: Participants will be followed up until the end of intensive care unit stay, an expected average of 3 days.
Therapeutic measures against postoperative delirium (POD)
Multicomponent/multimodal preventive measures to avoid POD are recorded by a questionnaire.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Team meetings on postoperative delirium (POD)
Multicomponent team meetings to discuss preventive measures to avoid POD will be recorded by a questionnaire.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Delirium incidence
Delirium incidence is measured with validated delirium scores.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Delirium duration
Delirium duration is measured in days.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Proportion of patients with adequate adherence
Proportion of patients with adequate (at least 4 out of 6 points) adherence to guidelines.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Proportion of patients with good adherence
Proportion of patients with good (at least 5 out of 6 points) adherence to guidelines
Measured: Up to 7 postoperative days
Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.
Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.
Measured: Up to 7 postoperative days
Guideline adherence
Percentage of guideline recommendations fulfilled per patient in the first 7 postoperative days.
Measured: Up to 7 postoperative days
Number of POD-free days within 7 days
Number of POD-free days within 7 days is measured postoperatively per patient:in
Measured: Up to 7 postoperative days
Delirium incidence within 7 days
Delirium incidence in patients who received delirium screening with validated delirium scores twice a day in at least two shifts (per-protocol analysis)
Measured: Up to 7 postoperative days
Anxiety
Anxiety is measured by Faces Anxiety Scale
Measured: Up to 5 postoperative days
Pain
Pain is measured with validated pain scores, scoring form 0 (no pain) to 10 (highest pain).
Measured: Up to 5 postoperative days
Depth of sedation
Depth of sedation is measured with the Richmond Agitation-Sedation Scale (RASS)
Measured: Up to 5 postoperative days
Functional performance
Functional performance is measured with the Glagow Coma Scale
Measured: Up to 5 postoperative days
Concomitant medication
Concomitant medication is measured in dosis per day.
Measured: Up to 5 postoperative days
Complications
Postoperative procedures/therapies and complications classified according to Clavien-Dindo
Measured: Up to 7 postoperative days
Infection status
Infection status is measured by chart review
Measured: Up to 7 postoperative days
Charlson comorbidity index (CCI)
The total score in the CCI is derived by summing the assigned weights of all comorbid conditions presented by the client. Higher scores indicate a more severe condition and consequently, a worse prognosis.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Change in cognitive status I
Cognitive status is measured with validated scores.
Measured: Up to 6 months
Change in cognitive status II
Cognitive status is measured with the MOCA in patients with positive and negative MiniCog.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Change in care level for BARMER patients
Care level is measured by chart review.
Measured: Up to 6 months
Change in utilization of inpatient care
Measured: Up to 6 months
Change in Patient-Reported Outcomes Measures (PROMs)
Patient-Reported Outcome Measures are recorded by PROM instruments.
Measured: Up to 3 months
Change in Patient-Reported Experience Measures (PREMs)
Patient-Reported Experience Measures are recorded by PREM instruments.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Change in the result from the detailed geriatric assessment and the frailty scoring
Frailty is measured by a modified Fried score.
Measured: Up to 6 months
Length of hospital stay
Length of hospital stay is measured in days.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Length of intensive care unit stay
Length of intensive care unit stay is measured in days.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Discharge type
Discharge type is taken from the medical record.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Length of stay in the recovery room
Length of stay in the recovery room is measured in hours.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Duration of surgery
Duration of surgery is measured in minutes.
Measured: Participants will be followed up until the end of operation, an expected average of 2 hours
Duration of anesthesia
Duration of anesthesia is measured in minutes.
Measured: Participants will be followed up until the end of operation, an expected average of 2 hours
Recommended therapies
Recommended therapies (physiotherapy, memory consultation, nutritional counseling) are measured by physical assessments.
Measured: Up to 6 months
Incidence of Post Intensive Care Syndrome (PICS)
Incidence of Post Intensive Care Syndrome (PICS) is measured by a composite of psychological, cognitive and functional scores.
Measured: Up to 3 months
Social data/Paragraph 21 data
Health economic data according to cost of patient care (The §21 dataset (diagnoses and operation-codes).
Measured: Up to 6 months
Social data
Evaluation of social data (pseudonymised) only for patients with statutory BARMER insurance and only with the patient's written consent to the processing of social data.
Measured: Up to 6 months
All-cause "mortality"
Mortality is measured inhospital and during ths FU phase.
Measured: Up to 6 months
Direct cost data
Direct care costs during inpatient treatment from the perspective of SHI (statutory health insurance).
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Follow-up costs
e.g. for outpatient/inpatient treatment, medication, remedies/aids and long-term care) from the perspective of statutory health insurance (SHI) and statutory long-term care insurance (LTCI)
Measured: Up to 6 months
Utilization of benefits
Utilization of benefits from (statutory health insurance) (SHI) and statutory long-term care insurance (GPV) (in particular need for long-term care, outpatient/inpatient treatment)
Measured: Up to 6 months
Personnel resources during the hospital stay
Personnel resources are measured by commitment time
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Investment costs
Costs are calculated with project data.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Maintenance costs
Costs are calculated with project data.
Measured: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start3 Jun 2024
- Primary completion15 Jan 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Digi-POD is a multicenter, prospective, longitudinal intervention study in a before-and-after design with quantitative process analysis
- Masking
- None (open label)
- Enrolment
- 844 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- BARMER, Technische Universität Berlin, Freie Universität Berlin, Ruhr University of Bochum
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445153
- Sponsor's protocol ID
- Digi-POD
- Status last verified
- Oct 2026
- First submitted
- 23 May 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitalized Clinical Decision Support for the Prevention of Postoperative Delirium (POD)
- ClinicalTrials.gov ID
- NCT06445153
- Acronym / sponsor ID
- Digi-POD
- Conditions
- Postoperative Delirium
- Keywords
- Clinical decision support system, Delirium risk factors, recommendations, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 844 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- BARMER, Technische Universität Berlin, Freie Universität Berlin, Ruhr University of Bochum
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Jun 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 project aims to improve patient safety, reduce barriers to the implementation of current guideline recommendations, reduce workload in clinics, increase efficiency in work processes and close gaps in care. Subprojects regarding delirium are implementes as well.
Detailed description
Postoperative delirium (POD) is the most common post-operative complication in the 70+ age group, affecting approximately fifteen percent of elderly patients. POD is characterized by impaired attention, awareness, and cognitive function. Both patients and their families are severely affected by the effects of this condition. While symptoms of POD occur during hospitalization, they have a critical impact on post-hospitalization quality of life, dependency on long-term care, and life expectancy.
The overarching goal of the Digi-POD project consortium is to develop a digital decision support system that makes current evidence-based guideline recommendations for POD machine-readable and allows automated, real-time validation against clinical data.
Sub-projects such as a point prevalence analysis on the incidence of delirium on 2 days at the Charité and a staff survey conducted by Aktionsbündnis Patientensicherheit e.V. in all study centers accompany this study.
Further substudies initiated by Charité Universitätsmedizin Berlin:
Two substudies (one feasibility study and one acceptance study) will be conducted using the prototype of the Clinical Brain Protection (CBP) application in Digi-POD patients at Charité.
Interviews and a review of project documentation to analyze obstacles and solution strategies for implementing data security/information security will be organized by Fraunhofer Fokus. The results will be incorporated into the Data Security project report.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Digi-POD is a multicenter, prospective, longitudinal intervention study in a before-and-after design with quantitative process analysis
| Arm | Type | Receives |
|---|---|---|
| Control phase | No intervention | –Control phase: in this phase, all study patients receive the standard therapy of the respective study center. |
| Intervention phase | Experimental | Other: Intervention with clinical decision support systemIn this phase, the intervention with Digi-POD is made available as Clinical Decision Support System. The intervention consists of providing patients, relatives and caregivers with Digi-POD decision support for the prevention of delirium and treatment decisions for delirium in accordance with the recommendations from the guidelines in addition to the standard therapy of the respective study center. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Age ≥ 70 years
- Male and female patients
- Patients who are insured through statutory health insurance
- Patients capable of giving consent for inclusion: by the patient, preoperatively
- Patients under guardianship for inclusion: written declaration of consent by guardian
Key exclusion criteria (6 listed)
- Insufficient language skills
- Moribund patients
- Study relatives
- Insufficient language skills
- No consent for data entry
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 |
|---|---|---|
| Intervention with clinical decision support systemTo this phase, patient data is automated and systematically analyzed in order to derive decision support based on current evidence and make it available to Digi-POD users (patients, relatives, nursing staff, doctors, other healthcare professionals). | Other | Intervention phase |
Primary outcome
Guideline adherence
Time frame: Up to five days
Guideline adherence: proportion of guideline recommendations fulfilled per patient in the first five postoperative days. The guideline adherence rate up to postoperative day 5 (or earlier if the patient has already been discharged) is calculated as a simple division: Number of recommendations fulfilled by number of all recommendations (N=6). A guideline adherence rate of at least 4 out of 6 points (67%) per patient is considered clinically sufficient.
Postperative delirium- free days
Time frame: Up to five days
Number of postoperative delirium- free days within 5 days postoperatively per patient.
50 secondary outcomes
Causes of delirium
Time frame: Up to seven days
Changes of Electroencephalography
Time frame: Participants will be followed up until the end of the operation, an expected average of 60 minutes
Blood pressure
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Pulse
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Heart rhythm
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Heart rate
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Oxygen saturation
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Amount of dexmedetomidine
Time frame: Participants will be followed up until the end of intensive care unit stay, an expected average of 3 days.
Therapeutic measures against postoperative delirium (POD)
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Team meetings on postoperative delirium (POD)
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Delirium incidence
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Delirium duration
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Proportion of patients with adequate adherence
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Proportion of patients with good adherence
Time frame: Up to 7 postoperative days
Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.
Time frame: Up to 7 postoperative days
Guideline adherence
Time frame: Up to 7 postoperative days
Number of POD-free days within 7 days
Time frame: Up to 7 postoperative days
Delirium incidence within 7 days
Time frame: Up to 7 postoperative days
Anxiety
Time frame: Up to 5 postoperative days
Pain
Time frame: Up to 5 postoperative days
Depth of sedation
Time frame: Up to 5 postoperative days
Functional performance
Time frame: Up to 5 postoperative days
Concomitant medication
Time frame: Up to 5 postoperative days
Complications
Time frame: Up to 7 postoperative days
Infection status
Time frame: Up to 7 postoperative days
Charlson comorbidity index (CCI)
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Change in cognitive status I
Time frame: Up to 6 months
Change in cognitive status II
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Change in care level for BARMER patients
Time frame: Up to 6 months
Change in utilization of inpatient care
Time frame: Up to 6 months
Change in Patient-Reported Outcomes Measures (PROMs)
Time frame: Up to 3 months
Change in Patient-Reported Experience Measures (PREMs)
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Change in the result from the detailed geriatric assessment and the frailty scoring
Time frame: Up to 6 months
Length of hospital stay
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Length of intensive care unit stay
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Discharge type
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Length of stay in the recovery room
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Duration of surgery
Time frame: Participants will be followed up until the end of operation, an expected average of 2 hours
Duration of anesthesia
Time frame: Participants will be followed up until the end of operation, an expected average of 2 hours
Recommended therapies
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- 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. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with clinical decision support system in people with Postoperative Delirium, run by Charite University, Berlin, Germany at 4 sites in Germany.
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 10 inclusion and 6 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: finished, as of the sponsor's last update on 23 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 4 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Guideline adherence (time frame: Up to five days). 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 23 Oct 2026.