COPD (Chronic Obstructive Pulmonary Disease)ElectrovestNCT07175012
ELECTROVEST: Electro-Stimulation Vibratory Vest for Pulmonary Rehabilitation in Patients With Chronic Respiratory Diseases
A study testing ELECTROVEST and The Vest® Model 105 in people with COPD (Chronic Obstructive Pulmonary Disease) and Cystic Fibrosis (CF), run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
Trial summary
This study will evaluate the effectiveness, safety, and tolerability of a novel wearable device, the ELECTROVEST, designed to improve airway clearance in patients with chronic respiratory diseases. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Cystic Fibrosis (CF), Bronchiectasis Adult
- What is being tested?
- ELECTROVEST and The Vest® Model 105
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 2 Oct 2023to 20 May 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Chronic Respiratory Diseases Diagnosed with chronic respiratory disease with bronchial hypersecretion: COPD, cystic fibrosis, bronchiectasis, or asthma
- Age >16 years
- Clinically stable (no exacerbations in past 4 weeks)
Who cannot join
- Risk of pneumothorax and/or barotrauma
- Risk or history of hemoptysis
- On active waiting list for lung transplant or surgery
- Musculoskeletal or other limiting condition
- Diagnosis of osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the effectiveness, safety, and tolerability of a novel wearable device, the ELECTROVEST, designed to improve airway clearance in patients with chronic respiratory diseases. The ELECTROVEST will integrate high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrostimulation. This crossover clinical trial will compare the performance of the ELECTROVEST with a standard HFCWO vest (The Vest®) in adult patients. Primary outcomes will include sputum expectoration and patient-reported comfort. The study will aim to determine whether this new system can optimize bronchial hygiene.
Read the detailed description
This is a prospective, crossover pilot study designed to evaluate the safety, efficacy, and tolerability of a novel respiratory therapy device, ELECTROVEST, in adult patients diagnosed with chronic respiratory diseases featuring bronchial hypersecretion, such as COPD, bronchiectasis, cystic fibrosis, and asthma.
ELECTROVEST is a wearable vest that integrates high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrical stimulation (NMES). This dual-action therapy aims to enhance airway clearance while also stimulating respiratory musculature.
The study will enroll 20 patients, using a non-probabilistic, intentional sampling strategy. Each participant will undergo two intervention phases, acting as their own control. The phases are separated by a 30-day washout period to minimize carryover effects.
Phase 1 (ELECTROVEST intervention): Participants receive standard fluid and aerosol therapy followed by vibratory therapy delivered by the ELECTROVEST device. Sessions include:
Warm-up phase: 2 minutes at 4 Hz
Active treatment: 16 minutes at 8 Hz
Cool-down phase: 2 minutes at 4 Hz
Phase 2 (Control intervention): Participants receive the same fluid and aerosol therapy, followed by vibratory therapy using standard HFCWO systems (The Vest® Model 105 ). The session follows:
Warm-up: 2 minutes at 13 Hz
Active treatment: 16 minutes at 20 Hz
Cool-down: 2 minutes at 13 Hz
Both interventions are conducted under clinical supervision. The effects will be assessed through pulmonary function tests, respiratory muscle strength, sputum analysis, oxygenation and hemodynamics, patient-reported symptoms, and blood biomarkers.
Pulmonary function and muscle strength will be measured before and 10 minutes after each intervention (FEV₁, DLCO, PImax, PEmax, SNIP). Sputum production and quality will be assessed by weight and purulence (Murray scale). Exercise tolerance will be evaluated via the 6-minute walk test.
Blood markers will be obtained before and 48 hours after each intervention, including:
Creatine phosphokinase (CPK-MM, CPK-BB)
C-reactive protein (CRP)
Peripheral leukocyte count
Creatinine, urea, albumin
Estimated glomerular filtration rate (eGFR)
Venous lactate
Monitoring during sessions includes:
Oxygen saturation (SpO₂)
Heart rate
Discomfort and dyspnea assessed via a visual analogue scale (VAS, 0-10), recorded at baseline, 5 minutes, and post-treatment.
This trial aims to identify physiological responses, tolerability, and short-term safety signals, while generating preliminary data on the potential dual utility of the ELECTROVEST device as a mucociliary clearance and respiratory muscle stimulation therapy.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Cystic Fibrosis (CF), Bronchiectasis Adult, Asthma Bronchiale
- Being tested
- ELECTROVEST, The Vest® Model 105
- Keywords
- Electrostimulation, High-Frequency Chest Wall Oscillation (HFCW, Airway Clearance, Chronic Respiratory Diseas, Respiratory Physiotherapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELECTROVESTDevice
Also called Electrostimulation Vibratory Vest
A wearable vest device that delivers airway clearance therapy through high-frequency chest wall oscillation (HFCWO) combined with surface neuromuscular electrostimulation (EEM). The session includes a 2-minute warm-up phase at 4 Hz, 16 minutes of active stimulation at 8 Hz, and a 2-minute recovery phase at 4 Hz (total duration: 20 minutes). The intervention is administered during supervised physiotherapy sessions to promote mucociliary clearance and respiratory muscle activation in patients with chronic respiratory diseases.
The Vest® Model 105Device
Also called Standard HFCWO Therapy
A conventional airway clearance therapy using a commercial high-frequency chest wall oscillation (HFCWO) device (The Vest® Model 105 or AffloVest®). The session includes a 2-minute warm-up phase at 13 Hz, 16 minutes of treatment at 20 Hz, and a 2-minute cool-down at 13 Hz (total duration: 20 minutes). This intervention serves as the active comparator in the crossover trial.
| Study group | Role | What they receive |
|---|---|---|
| ELECTROVEST Intervention | Experimental | Participants in this arm will receive airway clearance therapy using the ELECTROVEST, a wearable device that combines high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrostimulation (EEM). The intervention will be administered alongside standard fluid and aerosol therapy. This phase is designed to evaluate the device's safety, effectiveness, and tolerability. Receives: Device: ELECTROVEST |
| Standard HFCWO Therapy (Control) | Active comparator | Participants in this arm will receive standard airway clearance therapy using a high-frequency chest wall oscillation (HFCWO) vest device, either The Vest® Model 105 or the AffloVest®. The therapy will be combined with fluid and aerosol therapy and will serve as the comparator for evaluating the ELECTROVEST intervention. Participants will undergo this treatment after a 30-day washout period. Receives: Device: The Vest® Model 105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Expectorated Sputum
Total sputum weight (in grams) collected during and within 1 hour after each airway clearance session
Measured: Immediately post-intervention (within 1 hour)
Discomfort Level (VAS Score)
Subjective discomfort assessed using a 0-10 visual analogue scale (VAS), where 0 indicates no discomfort and 10 indicates maximum discomfort.
Measured: Immediately after each intervention session
Secondary outcomes (9)
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 measured via spirometry, according to ATS/ERS standards.
Measured: Baseline and 24-48 hours after each intervention.
Maximal Inspiratory Pressure (PImax)
Respiratory muscle strength measured in cmH2O using MicroRPM (Carefusion)
Measured: Baseline and 24-48 hours after each intervention.
Maximal Expiratory Pressure (PEmax)
Respiratory muscle strength measured in cmH2O using MicroRPM (Carefusion)
Measured: Baseline and 24-48 hours after each intervention.
Six-Minute Walk Distance (6MWD)
Distance walked in meters during the 6-minute walk test as a measure of functional capacity.
Measured: Baseline and 24-48 hours after each intervention.
DLCO (Diffusing Capacity for Carbon Monoxide)
Measured using single-breath technique, following ATS/ERS 2017 guidelines.
Measured: Baseline and 24-48 hours after each intervention.
Inflammatory and Muscle Biomarkers
Blood markers including creatine phosphokinase (CPK) and C-reactive protein (CRP), measured through standard blood analysis.
Measured: Baseline and 24-48 hours after each intervention.
Maximal Nasal Inspiratory Pressure (SNIP)
Nasal inspiratory pressure assessed using the SNIP test (Sniff Nasal Inspiratory Pressure) to evaluate inspiratory muscle strength. Unit measure cmH₂O.
Measured: Baseline and 24-48 hours after each intervention.
Estimated Glomerular Filtration Rate (eGFR)
Renal function assessed using estimated glomerular filtration rate (eGFR), calculated using the Cockcroft-Gault formula based on blood creatinine, age, weight, and sex.
Measured: Baseline and 24-48 hours after each intervention.
Health-Related Quality of Life (CASA-Q)
Health status and cough-related quality of life evaluated using the CASA-Q questionnaire (Cough and Sputum Assessment Questionnaire). Higher scores indicate better outcomes.
Measured: Baseline and 24-48 hours after each intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start2 Oct 2023
- Primary completion7 Mar 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary 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
- Crossover
- Model description
- This is a randomized, open-label, two-period crossover trial. Each participant will undergo two treatment phases: one with the investigational device (ELECTROVEST) and one with the standard HFCWO vest (The Vest®). A 30-day washout period will separate the two phases. Each participant will serve as their own control, allowing for intra-individual comparisons of outcomes such as sputum production, pulmonary function, respiratory muscle strength, and tolerability.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Responsible party
- Principal investigator, Rafael Rivilla Rivilla, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175012
- Sponsor's protocol ID
- EXP - 00111621 / ITC-20181118
- Acronym
- Electrovest
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is undecided whether individual participant data (IPD) will be shared. The study team is currently evaluating the feasibility of anonymizing and storing IPD in a secure repository in accordance with institutional and ethical guidelines.
Publications
Rivilla Rivilla R, Mendez Alonso AY, Roque Betancourt E, Vazquez Sanchez RM, Ortiz Molina I, Bonail Acuna B, Elena Perez MDM, Tejero Garcia S, Diaz Gutierrez F, Quintana Gallego E, Giraldez Sanchez MA, Cejudo Ramos P. Electrovest(R): A novel portable electro-vibratory device for airway clearance in chronic hypersecretory lung diseases. Pulmonology. 2025 Dec 31;31(1):2594888. doi: 10.1080/25310429.2025.2594888. Epub 2025 Dec 1.
PubMed 41324124
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELECTROVEST: Electro-Stimulation Vibratory Vest for Pulmonary Rehabilitation in Patients With Chronic Respiratory Diseases
- ClinicalTrials.gov ID
- NCT07175012
- Acronym / sponsor ID
- Electrovest / EXP - 00111621 / ITC-20181118
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Cystic Fibrosis (CF), Bronchiectasis Adult, Asthma Bronchiale
- Keywords
- Electrostimulation, High-Frequency Chest Wall Oscillation (HFCW, Airway Clearance, Chronic Respiratory Diseas, Respiratory Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 16 Sep 2025 (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 will evaluate the effectiveness, safety, and tolerability of a novel wearable device, the ELECTROVEST, designed to improve airway clearance in patients with chronic respiratory diseases. The ELECTROVEST will integrate high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrostimulation. This crossover clinical trial will compare the performance of the ELECTROVEST with a standard HFCWO vest (The Vest®) in adult patients. Primary outcomes will include sputum expectoration and patient-reported comfort. The study will aim to determine whether this new system can optimize bronchial hygiene.
Detailed description
This is a prospective, crossover pilot study designed to evaluate the safety, efficacy, and tolerability of a novel respiratory therapy device, ELECTROVEST, in adult patients diagnosed with chronic respiratory diseases featuring bronchial hypersecretion, such as COPD, bronchiectasis, cystic fibrosis, and asthma.
ELECTROVEST is a wearable vest that integrates high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrical stimulation (NMES). This dual-action therapy aims to enhance airway clearance while also stimulating respiratory musculature.
The study will enroll 20 patients, using a non-probabilistic, intentional sampling strategy. Each participant will undergo two intervention phases, acting as their own control. The phases are separated by a 30-day washout period to minimize carryover effects.
Phase 1 (ELECTROVEST intervention): Participants receive standard fluid and aerosol therapy followed by vibratory therapy delivered by the ELECTROVEST device. Sessions include:
Warm-up phase: 2 minutes at 4 Hz
Active treatment: 16 minutes at 8 Hz
Cool-down phase: 2 minutes at 4 Hz
Phase 2 (Control intervention): Participants receive the same fluid and aerosol therapy, followed by vibratory therapy using standard HFCWO systems (The Vest® Model 105 ). The session follows:
Warm-up: 2 minutes at 13 Hz
Active treatment: 16 minutes at 20 Hz
Cool-down: 2 minutes at 13 Hz
Both interventions are conducted under clinical supervision. The effects will be assessed through pulmonary function tests, respiratory muscle strength, sputum analysis, oxygenation and hemodynamics, patient-reported symptoms, and blood biomarkers.
Pulmonary function and muscle strength will be measured before and 10 minutes after each intervention (FEV₁, DLCO, PImax, PEmax, SNIP). Sputum production and quality will be assessed by weight and purulence (Murray scale). Exercise tolerance will be evaluated via the 6-minute walk test.
Blood markers will be obtained before and 48 hours after each intervention, including:
Creatine phosphokinase (CPK-MM, CPK-BB)
C-reactive protein (CRP)
Peripheral leukocyte count
Creatinine, urea, albumin
Estimated glomerular filtration rate (eGFR)
Venous lactate
Monitoring during sessions includes:
Oxygen saturation (SpO₂)
Heart rate
Discomfort and dyspnea assessed via a visual analogue scale (VAS, 0-10), recorded at baseline, 5 minutes, and post-treatment.
This trial aims to identify physiological responses, tolerability, and short-term safety signals, while generating preliminary data on the potential dual utility of the ELECTROVEST device as a mucociliary clearance and respiratory muscle stimulation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, open-label, two-period crossover trial. Each participant will undergo two treatment phases: one with the investigational device (ELECTROVEST) and one with the standard HFCWO vest (The Vest®). A 30-day washout period will separate the two phases. Each participant will serve as their own control, allowing for intra-individual comparisons of outcomes such as sputum production, pulmonary function, respiratory muscle strength, and tolerability.
| Arm | Type | Receives |
|---|---|---|
| ELECTROVEST Intervention | Experimental | Device: ELECTROVESTParticipants in this arm will receive airway clearance therapy using the ELECTROVEST, a wearable device that combines high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrostimulation (EEM). The intervention will be administered alongside standard fluid and aerosol therapy. This phase is designed to evaluate the device's safety, effectiveness, and tolerability. |
| Standard HFCWO Therapy (Control) | Active comparator | Device: The Vest® Model 105Participants in this arm will receive standard airway clearance therapy using a high-frequency chest wall oscillation (HFCWO) vest device, either The Vest® Model 105 or the AffloVest®. The therapy will be combined with fluid and aerosol therapy and will serve as the comparator for evaluating the ELECTROVEST intervention. Participants will undergo this treatment after a 30-day washout period. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Chronic Respiratory Diseases Diagnosed with chronic respiratory disease with bronchial hypersecretion: COPD, cystic fibrosis, bronchiectasis, or asthma
- Age >16 years
- Clinically stable (no exacerbations in past 4 weeks)
Key exclusion criteria (5 listed)
- Risk of pneumothorax and/or barotrauma
- Risk or history of hemoptysis
- On active waiting list for lung transplant or surgery
- Musculoskeletal or other limiting condition
- Diagnosis of osteoporosis
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 |
|---|---|---|
| ELECTROVESTAlso: Electrostimulation Vibratory VestA wearable vest device that delivers airway clearance therapy through high-frequency chest wall oscillation (HFCWO) combined with surface neuromuscular electrostimulation (EEM). The session includes a 2-minute warm-up phase at 4 Hz, 16 minutes of active stimulation at 8 Hz, and a 2-minute recovery phase at 4 Hz (total duration: 20 minutes). The intervention is administered during supervised physiotherapy sessions to promote mucociliary clearance and respiratory muscle activation in patients with chronic respiratory diseases. | Device | ELECTROVEST Intervention |
| The Vest® Model 105Also: Standard HFCWO TherapyA conventional airway clearance therapy using a commercial high-frequency chest wall oscillation (HFCWO) device (The Vest® Model 105 or AffloVest®). The session includes a 2-minute warm-up phase at 13 Hz, 16 minutes of treatment at 20 Hz, and a 2-minute cool-down at 13 Hz (total duration: 20 minutes). This intervention serves as the active comparator in the crossover trial. | Device | Standard HFCWO Therapy (Control) |
Primary outcome
Volume of Expectorated Sputum
Time frame: Immediately post-intervention (within 1 hour)
Total sputum weight (in grams) collected during and within 1 hour after each airway clearance session
Discomfort Level (VAS Score)
Time frame: Immediately after each intervention session
Subjective discomfort assessed using a 0-10 visual analogue scale (VAS), where 0 indicates no discomfort and 10 indicates maximum discomfort.
9 secondary outcomes
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and 24-48 hours after each intervention.
Maximal Inspiratory Pressure (PImax)
Time frame: Baseline and 24-48 hours after each intervention.
Maximal Expiratory Pressure (PEmax)
Time frame: Baseline and 24-48 hours after each intervention.
Six-Minute Walk Distance (6MWD)
Time frame: Baseline and 24-48 hours after each intervention.
DLCO (Diffusing Capacity for Carbon Monoxide)
Time frame: Baseline and 24-48 hours after each intervention.
Inflammatory and Muscle Biomarkers
Time frame: Baseline and 24-48 hours after each intervention.
Maximal Nasal Inspiratory Pressure (SNIP)
Time frame: Baseline and 24-48 hours after each intervention.
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and 24-48 hours after each intervention.
Health-Related Quality of Life (CASA-Q)
Time frame: Baseline and 24-48 hours after each intervention.
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 16 Sep 2025.
- Derived from this study: PubMed 41324124Rivilla Rivilla R, Mendez Alonso AY, Roque Betancourt E, Vazquez Sanchez RM, Ortiz Molina I, Bonail Acuna B, Elena Perez MDM, Tejero Garcia S, Diaz Gutierrez F, Quintana Gallego E, Giraldez Sanchez MA, Cejudo Ramos P. Electrovest(R): A novel portable electro-vibratory device for airway clearance in chronic hypersecretory lung diseases. Pulmonology. 2025 Dec 31;31(1):2594888. doi: 10.1080/25310429.2025.2594888. Epub 2025 Dec 1.
- Individual participant dataSharing planned: Undecided. It is undecided whether individual participant data (IPD) will be shared. The study team is currently evaluating the feasibility of anonymizing and storing IPD in a secure repository in accordance with institutional and ethical guidelines.
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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?
A study testing ELECTROVEST and The Vest® Model 105 in people with COPD (Chronic Obstructive Pulmonary Disease) and Cystic Fibrosis (CF), run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
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: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Volume of Expectorated Sputum (time frame: Immediately post-intervention (within 1 hour)). 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?
On the ClinicalTrials.gov record for NCT07175012, which also lists 1 linked publication.
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 Sep 2025.