GERD (Gastroesophageal Reflux Disease)NCT06613438
Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms
A study testing eGERD device in people with GERD (Gastroesophageal Reflux Disease), run by Gerd Care Medical Ltd at 5 sites in 2 countries.
Trial summary
The purpose of this research is to evaluate the safety and effectiveness of the eGERD device, which is a novel device for treating Gastroesophageal Reflux Disease (GERD). The main questions this research aims to answer are: 1. Does the eGERD device reduce acidity in the esophagus? 2. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- GERD (Gastroesophageal Reflux Disease)
- What is being tested?
- eGERD device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Sep 2024to Apr 2027
- 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 22 - 75
- Has been typically suffering from at least three heartburn and/or regurgitation episodes per week during the past three months.
- Undergone a wireless (Bravo) pH monitoring test during the past 24 months prior to enrollment into the current study, following a 7-day (min.) off-PPI period, with AET ≥6% (as defined in section 7.2) in at least 2 monitoring days AND when averaged over all monitoring days of the test; or, in the absence of such testing, has been determined by the Principal Investigator (PI), based on a detailed anamnesis and with written agreement from the Medical Director, to have gastroesophageal reflux disease (GERD) other than functional GERD; or Undergone a catheter-based pH monitoring test during the past 24 months prior to enrollment into the current study, following a 7-day (min.) off-PPI period, with AET ≥6% (as defined in section 7.2); or, in the absence of such testing, has been determined by the Principal Investigator (PI), based on a detailed anamnesis and with written agreement from the Medical Director, to have gastroesophageal reflux disease (GERD) other than functional GERD.
- Able and willing to give informed consent for participation in the study and to comply with all study requirements, including operating the smartphone application.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- Previously undergoing gastric or esophageal surgery
- Active peptic ulcer disease or symptomatic helicobacter
- Esophageal or gastric varices or esophageal peptic stricture
- Severe dysphagia
- History of suspected or confirmed esophageal or gastric cancer
- History of any other malignancy in the last 2 years
Show all 28Show fewer
- Pregnant women or women intending to become pregnant during the trial period
- Uncontrolled diabetes mellitus, defined as HbA1c \> 7.5%
- Severe cardiac conditions such as cardiac arrhythmia or ischemia or cardiac pacemaker / defibrillator
- Having any implanted electrical device (e.g. sacral nerve stimulation, brain stimulator, others)
- Known allergy to the device's adhesives/patches
- Severe pulmonary diseases
- History of significant multisystem diseases (e.g. kidney failure, liver failure)
- Known autoimmune or a connective tissue disorder (e.g. scleroderma, CREST-syndrome, Sjogren's Syndrome), requiring therapy in the preceding 2 years
- History of Barrett's esophagus
- Para-esophageal hiatal hernia
- Known history of sliding hiatal hernia ≥4 cm in the last 3 years
- Known history of erosive esophagitis Grade C or D (LA classification) in the past 5 years
- Obesity, defined as BMI\>32
- History of gastroparesis
- History of fibromyalgia, epilepsy, endometriosis
- Umbilical hernia \>3cm
- Past usage experience with the study device
- Those currently enrolled in any other interventional clinical study
- Inability to sign the informed consent
- Inability to understand and fill the reports and questionnaires included in the study
- Inability to follow the study requisites
- Other medical conditions/medications that would interfere with subject safety or data collection in the opinion of the PI
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Israel4 sites, 4 recruiting
- Recruiting
Gastroenterology department, Emek medical center (EMC)
Afula
Fahmi Shibli, MD, 972544508118, fahmi_sh@clalit.org.il
Fahmi Shibli, MD
- Recruiting
Gastroenterology department, Rambam Health Care Campus
Haifa
Rita Brun, MD, 972502061142, r_brun@rambam.health.gov.il
Rita Brun, MD
- Recruiting
Gastroenterology department, Rabin medical center (RMC)
Petah Tikva
Ram Dickman, Prof., 972523428692, dickmanr@clalit.org.il
Ram Dickman, Prof.
- Recruiting
Gastroenterology department, Tel Aviv Sourasky Medical Center (Ichilov)
Tel Aviv
Yoav Mazor, MD, 97236974281, yoavmaz@tlvmc.gov.il
Yoav Mazor, MD
United States1 site, 1 recruiting
- Not yet recruiting
Division of Gastroenterology & Hepatology Feinberg School of Medicine Northwestern University
Chicago, Illinois, 60611-2927
Ofer Z Fass, MD, 312.695.0182, ofer.fass@northwestern.edu
About this study
Official title: The Effect of Non-Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD)
The purpose of this research is to evaluate the safety and effectiveness of the eGERD device, which is a novel device for treating Gastroesophageal Reflux Disease (GERD).
The main questions this research aims to answer are:
Read more
- Does the eGERD device reduce acidity in the esophagus?
- Does the eGERD device reduce GERD symptoms such as heartburn and regurgitation?
- What medical problems do participants have when using the eGERD device?
To assess the acidity in the esophagus, a wireless standard-of-care capsule called Bravo will be placed in the participants esophagus (throat) for several days.
To assess GERD symptoms, participants will be requested to report symptoms they experience using a smartphone application.
Researchers will compare a real version of the eGERD device to a sham version (a look-alike device that has no therapeutic effect) to see if the eGERD device is effective in treating GERD.
Read the detailed description
The study includes two consecutive phases: a 14-day washout phase followed by a 28-day device treatment phase.
The washout phase starts on or shortly after the Screening visit, in which the participants sign the informed consent form (ICF) and their eligibility criteria are assessed. The first day of the washout phase is considered Day 1 of the study.
In the washout phase, participants are instructed to avoid any GERD-treatment medications (including antacids), either prescribed or over-the-counter (OTC), and to keep their regular daily routines.
Participants are also instructed to report occurrence and severity of GERD-related symptoms using the eGERD smartphone application.
GERD-HRQL questionnaire are filled at the onset (Day 1) and at the end (Day 14) of this phase. Questionnaire score obtained at the end of the washout phase (QoL Score baseline) are regarded as baseline for the QoL secondary endpoint.
On the last day of the washout phase (Day 14), a 24h wireless pH monitoring test (Bravo) is initiated, in order to obtain acid exposure time (AET) and DeMeester score (DM) baseline levels.
The device treatment phase consists of continuous usage of the study device for 28 days.
At the onset of the device treatment phase, the pH monitoring data is downloaded and analyzed, to establish AET and DM baseline levels. To be eligible for randomization and study device usage, a participant must have (i) at least 18 hours of baseline monitoring data , and (ii) abnormal baseline AET (above 6%). Ineligible subjects are classified as screen failures. participants with insufficient baseline monitoring data (less than 18 monitoring hours) are offered to extend the baseline monitoring for another 24 hours.
Upon establishing participant eligibility and performing randomization, a new 96h wireless pH monitoring test is initiated using the same Bravo capsule already in place. At the same time, the participant starts using the study device. One day later, a short clinic visit is held in which proper operation of the study device is verified. At the end of the 96h pH monitoring test, the monitoring system is collected and the data downloaded.
Usage of the study device is continued from randomization for 28 days. Esophageal acid exposure time (AET) and DeMeester score (DM) obtained from the 24h wireless pH monitoring test are regarded as baseline for AET primary endpoint and DeMeester score secondary endpoint, respectively.
Esophageal acid exposure time and DeMeester score obtained from the last Complete Monitoring Day of the 96h monitoring test are considered AET primary endpoint and DeMeester score secondary endpoint, respectively.
Throughout this phase, participants are using a study device (either functional or sham), after receiving instructions on its usage. Participants are instructed to use the study device 24 hours per day, 7 days per week (excluding device charging, bathing, sporting, private situations, etc.).
Usage of antacids (Gaviscon Regular Strength antacid tablets, 2-4 tablets, up to 4 times a day) as a rescue treatment is allowed after the Bravo system has been collected from the participant (Day 19). Rescue treatment usage is reported and recorded. Usage of any other type of GERD-treatment is prohibited throughout the entire phase.
GERD-HRQL questionnaire is filled at the end of this phase (or on end-of-study visit, in case of early termination). Resulting score is regarded as QoL secondary endpoint.
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- Being tested
- eGERD device, eGERD_Sham
- Keywords
- Electrostimulation, Refulx, Regurgitation, eGERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eGERD deviceDevice
The eGERD device is a novel device developed by GerdCare Medical for reducing symptoms of GERD. The device is noninvasive and designed for self-use in the home environment. It is applied on the abdominal skin and generates electrical stimulation pulses.
For optimized effect, the stimulation is synchronized with the breathing phase, such that it is active mainly during inhalation. The stimulation intensity can be adjusted by the user.
eGERD_ShamDevice
The eGERD_Sham is a sham version of the eGERD device. It is capable of inducing sensation of electrical stimulation pulses in the target abdominal muscles without a therapeutic effect. Aside from this difference, the eGERD_Sham is identical to the eGERD device.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Participants in the active arm will be using a functional version of the investigational device for 28 days. Receives: Device: eGERD device |
| Control | Sham comparator | Participants in the control arm will be using a sham version of the investigational device for 28 days. Receives: Device: eGERD_Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of Adverse Device Effects (ADEs)
Number and severity of Adverse Device Effects (ADEs) occurring when using the investigational device.
Measured: From the beginning (Day 15) to the end (Day 42) of the device treatment phase
Change in esophageal acid exposure time
Magnitude of change (from baseline to within normal limits) of acid exposure time (AET), as measured in a wireless pH monitoring test (Bravo™) conducted following a 14-day washout phase.
Measured: First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
Secondary outcomes (6)
Change in DeMeester Score
Magnitude of change (from baseline to within normal limits) of DeMeester score, as measured in a wireless pH monitoring test (Bravo™) conducted following a 14-day washout phase.
Measured: First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
Quality of life improvement
Magnitude of change (from baseline) of the total score obtained in GERD-HRQL (GERD Health-Related Quality of Life) questionnaire.
Measured: End of the washout phase (Day 14) and end of the device treatment phase (Day 42)
Change in the frequency of regurgitation events
Magnitude of change in the frequency of regurgitation events reported by patients using the smartphone application, when averaged over the last week of the device treatment phase, compared to the last week of the washout phase
Measured: End of the washout phase (Day 14) and end of the device treatment phase (Day 42)
Change in the frequency of heartburn events
Magnitude of change in the frequency of heartburn events reported by patients using the smartphone application, when averaged over the last week of the device treatment phase, compared to the last week of the washout phase
Measured: End of the washout phase (Day 14) and end of the device treatment phase (Day 42)
Usage of rescue treatment
The daily number of reported rescue treatment events, averaged over the period allowed for rescue treatment
Measured: From the end of the pH monitoring test (Day 19) to the end of the device treatment phase (Day 42)
Number of subjects electing to withdraw their consent
Number of subjects electing to withdraw their consent during the device treatment phase
Measured: From the beginning (Day 15) to the end (Day 42) of the device treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start15 Sep 2024
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD (Gastroesophageal Reflux Disease)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gerd Care Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613438
- Sponsor's protocol ID
- CL-PRO-0300
- Other IDs
- MOH_2024-05-12_013278
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2024
- Last updated
- 23 Jun 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT06613438
- Acronym / sponsor ID
- CL-PRO-0300
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- Keywords
- Electrostimulation, Refulx, Regurgitation, eGERD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Gerd Care Medical LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 26 Sep 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 purpose of this research is to evaluate the safety and effectiveness of the eGERD device, which is a novel device for treating Gastroesophageal Reflux Disease (GERD).
The main questions this research aims to answer are:
- Does the eGERD device reduce acidity in the esophagus?
- Does the eGERD device reduce GERD symptoms such as heartburn and regurgitation?
- What medical problems do participants have when using the eGERD device?
To assess the acidity in the esophagus, a wireless standard-of-care capsule called Bravo will be placed in the participants esophagus (throat) for several days.
To assess GERD symptoms, participants will be requested to report symptoms they experience using a smartphone application.
Researchers will compare a real version of the eGERD device to a sham version (a look-alike device that has no therapeutic effect) to see if the eGERD device is effective in treating GERD.
Detailed description
The study includes two consecutive phases: a 14-day washout phase followed by a 28-day device treatment phase.
The washout phase starts on or shortly after the Screening visit, in which the participants sign the informed consent form (ICF) and their eligibility criteria are assessed. The first day of the washout phase is considered Day 1 of the study.
In the washout phase, participants are instructed to avoid any GERD-treatment medications (including antacids), either prescribed or over-the-counter (OTC), and to keep their regular daily routines.
Participants are also instructed to report occurrence and severity of GERD-related symptoms using the eGERD smartphone application.
GERD-HRQL questionnaire are filled at the onset (Day 1) and at the end (Day 14) of this phase. Questionnaire score obtained at the end of the washout phase (QoL Score baseline) are regarded as baseline for the QoL secondary endpoint.
On the last day of the washout phase (Day 14), a 24h wireless pH monitoring test (Bravo) is initiated, in order to obtain acid exposure time (AET) and DeMeester score (DM) baseline levels.
The device treatment phase consists of continuous usage of the study device for 28 days.
At the onset of the device treatment phase, the pH monitoring data is downloaded and analyzed, to establish AET and DM baseline levels. To be eligible for randomization and study device usage, a participant must have (i) at least 18 hours of baseline monitoring data , and (ii) abnormal baseline AET (above 6%). Ineligible subjects are classified as screen failures. participants with insufficient baseline monitoring data (less than 18 monitoring hours) are offered to extend the baseline monitoring for another 24 hours.
Upon establishing participant eligibility and performing randomization, a new 96h wireless pH monitoring test is initiated using the same Bravo capsule already in place. At the same time, the participant starts using the study device. One day later, a short clinic visit is held in which proper operation of the study device is verified. At the end of the 96h pH monitoring test, the monitoring system is collected and the data downloaded.
Usage of the study device is continued from randomization for 28 days. Esophageal acid exposure time (AET) and DeMeester score (DM) obtained from the 24h wireless pH monitoring test are regarded as baseline for AET primary endpoint and DeMeester score secondary endpoint, respectively.
Esophageal acid exposure time and DeMeester score obtained from the last Complete Monitoring Day of the 96h monitoring test are considered AET primary endpoint and DeMeester score secondary endpoint, respectively.
Throughout this phase, participants are using a study device (either functional or sham), after receiving instructions on its usage. Participants are instructed to use the study device 24 hours per day, 7 days per week (excluding device charging, bathing, sporting, private situations, etc.).
Usage of antacids (Gaviscon Regular Strength antacid tablets, 2-4 tablets, up to 4 times a day) as a rescue treatment is allowed after the Bravo system has been collected from the participant (Day 19). Rescue treatment usage is reported and recorded. Usage of any other type of GERD-treatment is prohibited throughout the entire phase.
GERD-HRQL questionnaire is filled at the end of this phase (or on end-of-study visit, in case of early termination). Resulting score is regarded as QoL secondary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: eGERD deviceParticipants in the active arm will be using a functional version of the investigational device for 28 days. |
| Control | Sham comparator | Device: eGERD_ShamParticipants in the control arm will be using a sham version of the investigational device for 28 days. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged 22 - 75
- Has been typically suffering from at least three heartburn and/or regurgitation episodes per week during the past three months.
- Undergone a wireless (Bravo) pH monitoring test during the past 24 months prior to enrollment into the current study, following a 7-day (min.) off-PPI period, with AET ≥6% (as defined in section 7.2) in at least 2 monitoring days AND when averaged over all monitoring days of the test; or, in the absence of such testing, has been determined by the Principal Investigator (PI), based on a detailed anamnesis and with written agreement from the Medical Director, to have gastroesophageal reflux disease (GERD) other than functional GERD; or Undergone a catheter-based pH monitoring test during the past 24 months prior to enrollment into the current study, following a 7-day (min.) off-PPI period, with AET ≥6% (as defined in section 7.2); or, in the absence of such testing, has been determined by the Principal Investigator (PI), based on a detailed anamnesis and with written agreement from the Medical Director, to have gastroesophageal reflux disease (GERD) other than functional GERD.
- Able and willing to give informed consent for participation in the study and to comply with all study requirements, including operating the smartphone application.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Key exclusion criteria (28 listed)
- Previously undergoing gastric or esophageal surgery
- Active peptic ulcer disease or symptomatic helicobacter
- Esophageal or gastric varices or esophageal peptic stricture
- Severe dysphagia
- History of suspected or confirmed esophageal or gastric cancer
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 |
|---|---|---|
| eGERD deviceThe eGERD device is a novel device developed by GerdCare Medical for reducing symptoms of GERD. The device is noninvasive and designed for self-use in the home environment. It is applied on the abdominal skin and generates electrical stimulation pulses. For optimized effect, the stimulation is synchronized with the breathing phase, such that it is active mainly during inhalation. The stimulation intensity can be adjusted by the user. | Device | Active |
| eGERD_ShamThe eGERD_Sham is a sham version of the eGERD device. It is capable of inducing sensation of electrical stimulation pulses in the target abdominal muscles without a therapeutic effect. Aside from this difference, the eGERD_Sham is identical to the eGERD device. | Device | Control |
Primary outcome
Number and severity of Adverse Device Effects (ADEs)
Time frame: From the beginning (Day 15) to the end (Day 42) of the device treatment phase
Number and severity of Adverse Device Effects (ADEs) occurring when using the investigational device.
Change in esophageal acid exposure time
Time frame: First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
Magnitude of change (from baseline to within normal limits) of acid exposure time (AET), as measured in a wireless pH monitoring test (Bravo™) conducted following a 14-day washout phase.
6 secondary outcomes
Change in DeMeester Score
Time frame: First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
Quality of life improvement
Time frame: End of the washout phase (Day 14) and end of the device treatment phase (Day 42)
Change in the frequency of regurgitation events
Time frame: End of the washout phase (Day 14) and end of the device treatment phase (Day 42)
Change in the frequency of heartburn events
Time frame: End of the washout phase (Day 14) and end of the device treatment phase (Day 42)
Usage of rescue treatment
Time frame: From the end of the pH monitoring test (Day 19) to the end of the device treatment phase (Day 42)
Number of subjects electing to withdraw their consent
Time frame: From the beginning (Day 15) to the end (Day 42) of the device treatment 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 23 Jun 2026.
- Related InfoLink provided by the sponsor.
- 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.
Division of Gastroenterology & Hepatology Feinberg School of Medicine Northwestern University
Chicago, United States
Gastroenterology department, Emek medical center (EMC)
Afula, Israel
Gastroenterology department, Rambam Health Care Campus
Haifa, Israel
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eGERD device in people with GERD (Gastroesophageal Reflux Disease), run by Gerd Care Medical Ltd at 5 sites in 2 countries.
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 5 inclusion and 28 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of Adverse Device Effects (ADEs) (time frame: From the beginning (Day 15) to the end (Day 42) of the device treatment phase). 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 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.