Vocal Cord Paralysis, BilateralBVCP-BiPAPNCT07042971
Peri-operative BiPAP to Prevent Tracheostomy in High-Risk Bilateral Vocal-Cord Paralysis (BVCP)
A study testing Pre-operative BiPAP Training, Post-extubation BiPAP Support and Standard Peri-operative Care in people with Vocal Cord Paralysis, Bilateral and Airway Obstruction, Postoperative, run by Fujian Medical University at 1 site in China.
Trial summary
Why: After thyroid or neck surgery, some patients can lose movement of both vocal cords (bilateral vocal-cord paralysis, BVCP). This can make breathing difficult and often leads to an emergency or preventive tracheostomy ("wind-pipe") surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vocal Cord Paralysis, Bilateral, Airway Obstruction, Postoperative, Thyroid Neoplasms
- What is being tested?
- Pre-operative BiPAP Training, Post-extubation BiPAP Support and Standard Peri-operative Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2029
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80 years.
- Scheduled for thyroidectomy or other neck surgery under general anesthesia.
- High risk of bilateral vocal-cord paralysis (BVCP) defined by at least ONE of:
- Pre-operative flexible laryngoscopy showing fixed vocal cords at midline or paramedian position, or glottic gap ≤ 3 mm; OR
- Presence of ≥ 2 high-risk factors:
- Planned bilateral central plus lateral neck dissection
Show all 11Show fewer
- Re-operative bilateral neck surgery or dense scarring
- Tumor involving both recurrent laryngeal nerves or crico-arytenoid joints
- Severe obstructive sleep apnea (AHI ≥ 30 events/hour)
- Body-mass index (BMI) ≥ 30 kg/m²
- Able to tolerate and give informed consent for BiPAP mask use.
Who cannot join
- Emergency surgery or need for immediate tracheostomy.
- Existing tracheostomy or home ventilator dependence.
- Inability to protect airway (e.g., Glasgow Coma Scale < 13).
- Craniofacial anomaly or skin condition precluding mask seal.
- Pregnancy or breastfeeding.
- Participation in another interventional trial that could interfere with study endpoints.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized Controlled Trial of Pre-operative BiPAP Training and Post-extubation BiPAP Support to Reduce Peri-operative Tracheostomy or Re-intubation in Patients at High Risk for Bilateral Vocal-Cord Paralysis
Why: After thyroid or neck surgery, some patients can lose movement of both vocal cords (bilateral vocal-cord paralysis, BVCP). This can make breathing difficult and often leads to an emergency or preventive tracheostomy ("wind-pipe") surgery.
What: This study will test two simple ways to avoid a tracheostomy:
Read more
Pre-operative BiPAP sleep training - patients practice sleeping with a non-invasive BiPAP breathing machine for seven nights before surgery so they become comfortable with the mask and pressures.
Immediate post-extubation BiPAP support - the same BiPAP machine is started as soon as the breathing tube is removed in the operating room or recovery area.
How: Adults (18-80 years) who already have, or are at high risk of getting, BVCP will be randomly assigned to one of four groups in a 2 × 2 design:
- Group 1: training + post-op BiPAP • Group 2: training only • Group 3: post-op BiPAP only • Group 4: standard care (no planned BiPAP).
Main goal: To find out whether either or both BiPAP strategies reduce the need for tracheostomy or re-intubation during the first 7 days after surgery.
What participants do: Eligible patients will undergo routine surgery plus the assigned BiPAP plan. Breathing events, comfort, hospital stay, and voice quality will be recorded up to 6 months.
Potential benefit/risk: BiPAP is non-invasive and already FDA-cleared for home and hospital use, but some people may feel mask discomfort or air leaks. Trained staff will adjust settings and stop BiPAP if serious problems occur.
Read the detailed description
Background and Rationale Bilateral vocal-cord paralysis (BVCP) after thyroid and neck procedures poses an immediate risk of airway obstruction. Historical management favors prophylactic or rescue tracheostomy; however, tracheostomy carries morbidity, cost, and long-term stigma. Case series suggest that non-invasive ventilation (NIV) using BiPAP can stent the glottic opening while providing ventilatory support, but no prospective randomized data exist.
Objectives Primary: Compare the 7-day composite rate of (a) tracheostomy or (b) re-intubation among patients managed with (i) pre-operative BiPAP training, (ii) immediate post-extubation BiPAP, both, or neither.
Secondary: BiPAP usage hours, hypoxemic events, ICU/hospital length of stay, Voice Handicap Index-10 (VHI-10) and Eating Assessment Tool-10 (EAT-10) scores, normalized glottic area (NGA %) at 6 months, cost.
Study Design Multicenter, open-label, factorial (2 × 2) randomized controlled trial. Randomization (block size = 4) stratified by center. Total planned enrollment: 204 (to allow for 10 % attrition), yielding ~46 evaluable participants per arm.
Interventions Pre-operative BiPAP training: nightly ≥ 4 h for 7 consecutive nights, pressure ladder EPAP 6 → 8 cmH₂O / IPAP 12 → 16 cmH₂O, recorded on SD-card.
Post-extubation BiPAP: same machine and pressures applied immediately after extubation and continued ≥ 48 h or until patient maintains SpO₂ ≥ 94 % for 24 h without BiPAP.
Standard care includes oxygen, nebulization, steroids, and surgical airway if necessary.
Eligibility (key points) Inclusion: age 18-80; scheduled thyroid/neck surgery; pre-op fixed cords at midline/paramedian or glottic gap ≤ 3 mm OR ≥ 2 high-risk factors (bilateral neck re-entry, tumor near both RLNs, bilateral C + L lymph-node dissection, severe OSA AHI ≥ 30, BMI ≥ 30).
Exclusion: emergency surgery, existing tracheostomy, ventilator dependence, mask intolerance, pregnancy, inability to consent.
Outcomes and Assessments
- Airway status monitored continuously POD 0-2, then daily to POD 7.
- ABG, pulse oximetry, and flexible laryngoscopy performed per protocol schedule.
- Adverse events graded by CTCAE v5.0; DSMB halting rule: ≥ 3 grade 3 airway failures in any arm.
Statistical Methods Intention-to-treat for primary endpoint. Log-binomial regression with center as random effect to estimate risk ratios for each main effect and their interaction. Kaplan-Meier curves for "tracheostomy-free survival." Interim analysis at 50 % information using O'Brien-Fleming alpha-spending.
Regulatory Status Devices (ResMed AirCurve 10 ST; Philips A40) are FDA-cleared class II ventilators (510(k)); IRB classified study as non-significant-risk device research exempt from IDE under 21 CFR 812.2(b).
Data Sharing De-identified individual participant data and statistical code will be shared upon reasonable request 6 months after final publication.
- Conditions
- Vocal Cord Paralysis, Bilateral, Airway Obstruction, Postoperative, Thyroid Neoplasms, Sleep Apnea, Obstructive
- Being tested
- Pre-operative BiPAP Training, Post-extubation BiPAP Support, Standard Peri-operative Care
- Keywords
- BiPAP, Non-invasive Ventilation, Continuous Positive Airway Pressure, Peri-operative Airway Management, Tracheostomy Avoidance, Thyroidectomy, Neck Surgery, Glottic Stenosis, Pre-operative Sleep Training, Voice Handicap Index
- Medical subject headings
- Vocal Cord Paralysis, Airway Obstruction, Thyroid Neoplasms, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative BiPAP TrainingDevice
Seven consecutive nights (≥ 4 h/night) of BiPAP use at home or on ward, pressure ladder EPAP 6→8 cmH₂O / IPAP 12→16 cmH₂O, recorded on SD card; devices: ResMed AirCurve 10 ST or Philips A40.
Post-extubation BiPAP SupportDevice
Same BiPAP device started immediately after tracheal extubation; EPAP 8 cmH₂O / IPAP 14 cmH₂O (or patient's final training setting) maintained ≥ 48 h, then weaned when SpO₂ ≥ 94 % off-BiPAP for 24 h.
Standard Peri-operative CareOther
Routine oxygen, nebulized steroids, airway monitoring; rescue re-intubation or tracheostomy per institutional protocol; no planned BiPAP unless crossover criteria met.
| Study group | Role | What they receive |
|---|---|---|
| Training + Post-op BiPAP | Experimental | Participants receive 7-day Pre-operative BiPAP Training and Post-extubation BiPAP Support for ≥ 48 h after surgery. Receives: Device: Post-extubation BiPAP Support; Other: Standard Peri-operative Care |
| Training Only | Experimental | Participants receive 7-day Pre-operative BiPAP Training. No routine BiPAP after extubation; peri-operative care otherwise standard. Receives: Other: Standard Peri-operative Care |
| Post-op BiPAP Only | Experimental | No pre-op training. BiPAP started immediately after extubation and continued ≥ 48 h. Receives: Device: Pre-operative BiPAP Training; Device: Post-extubation BiPAP Support |
| Standard Care | Active comparator | No planned BiPAP. Airway managed with institutional standard care only. Receives: Device: Pre-operative BiPAP Training; Other: Standard Peri-operative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite "Airway Failure" (Tracheostomy OR Re-intubation)
Post-operative Day 0 through Day 7
Measured: The first occurrence of (a) surgical tracheostomy or (b) endotracheal re-intubation for respiratory distress within 7 days after extubation. Event status adjudicated by an independent investigator using pre-defined criteria.
Secondary outcomes (5)
Total BiPAP Usage Hours
Sum of hours recorded by device SD-card while patient is connected to BiPAP during the first 48 h after extubation.
Measured: Post-op Day 0 to Day 2 (48 hours)
Hypoxemic Episodes (SpO₂ < 90 % ≥ 3 min)
Number of discrete desaturation events captured by continuous pulse oximetry logs.
Measured: Post-op Day 0 to Day 2
ICU Length of Stay
Hours from ICU admission to ICU discharge documented in EMR.
Measured: Surgery end → ICU discharge (up to 7 days)
Voice Handicap Index-10 (VHI-10)
Patient-reported outcome; total score 0-40 (higher = worse voice handicap).
Measured: 6 months (±14 days) post-op
Normalized Glottic Area (NGA %)
Percentage of glottic opening area measured on flexible laryngoscopy and normalized to true-vocal-fold length.
Measured: Baseline pre-op and 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord Paralysis, BilateralStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Two-by-two factorial randomized controlled trial testing the independent and combined effects of (A) 7-day pre-operative BiPAP training and (B) immediate post-extubation BiPAP support.
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University Union Hospital
- Investigators
- Bo WANG, MD, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042971
- Sponsor's protocol ID
- BVCP-BiPAP
- Acronym
- BVCP-BiPAP
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Trial of Pre-operative BiPAP Training and Post-extubation BiPAP Support to Reduce Peri-operative Tracheostomy or Re-intubation in Patients at High Risk for Bilateral Vocal-Cord Paralysis
- ClinicalTrials.gov ID
- NCT07042971
- Acronym / sponsor ID
- BVCP-BiPAP / BVCP-BiPAP
- Conditions
- Vocal Cord Paralysis, Bilateral, Airway Obstruction, Postoperative, Thyroid Neoplasms, Sleep Apnea, Obstructive
- Keywords
- BiPAP, Non-invasive Ventilation, Continuous Positive Airway Pressure, Peri-operative Airway Management, Tracheostomy Avoidance, Thyroidectomy, Neck Surgery, Glottic Stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Jun 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.
Why: After thyroid or neck surgery, some patients can lose movement of both vocal cords (bilateral vocal-cord paralysis, BVCP). This can make breathing difficult and often leads to an emergency or preventive tracheostomy ("wind-pipe") surgery.
What: This study will test two simple ways to avoid a tracheostomy:
Pre-operative BiPAP sleep training - patients practice sleeping with a non-invasive BiPAP breathing machine for seven nights before surgery so they become comfortable with the mask and pressures.
Immediate post-extubation BiPAP support - the same BiPAP machine is started as soon as the breathing tube is removed in the operating room or recovery area.
How: Adults (18-80 years) who already have, or are at high risk of getting, BVCP will be randomly assigned to one of four groups in a 2 × 2 design:
- Group 1: training + post-op BiPAP • Group 2: training only • Group 3: post-op BiPAP only • Group 4: standard care (no planned BiPAP).
Main goal: To find out whether either or both BiPAP strategies reduce the need for tracheostomy or re-intubation during the first 7 days after surgery.
What participants do: Eligible patients will undergo routine surgery plus the assigned BiPAP plan. Breathing events, comfort, hospital stay, and voice quality will be recorded up to 6 months.
Potential benefit/risk: BiPAP is non-invasive and already FDA-cleared for home and hospital use, but some people may feel mask discomfort or air leaks. Trained staff will adjust settings and stop BiPAP if serious problems occur.
Detailed description
Background and Rationale Bilateral vocal-cord paralysis (BVCP) after thyroid and neck procedures poses an immediate risk of airway obstruction. Historical management favors prophylactic or rescue tracheostomy; however, tracheostomy carries morbidity, cost, and long-term stigma. Case series suggest that non-invasive ventilation (NIV) using BiPAP can stent the glottic opening while providing ventilatory support, but no prospective randomized data exist.
Objectives Primary: Compare the 7-day composite rate of (a) tracheostomy or (b) re-intubation among patients managed with (i) pre-operative BiPAP training, (ii) immediate post-extubation BiPAP, both, or neither.
Secondary: BiPAP usage hours, hypoxemic events, ICU/hospital length of stay, Voice Handicap Index-10 (VHI-10) and Eating Assessment Tool-10 (EAT-10) scores, normalized glottic area (NGA %) at 6 months, cost.
Study Design Multicenter, open-label, factorial (2 × 2) randomized controlled trial. Randomization (block size = 4) stratified by center. Total planned enrollment: 204 (to allow for 10 % attrition), yielding ~46 evaluable participants per arm.
Interventions Pre-operative BiPAP training: nightly ≥ 4 h for 7 consecutive nights, pressure ladder EPAP 6 → 8 cmH₂O / IPAP 12 → 16 cmH₂O, recorded on SD-card.
Post-extubation BiPAP: same machine and pressures applied immediately after extubation and continued ≥ 48 h or until patient maintains SpO₂ ≥ 94 % for 24 h without BiPAP.
Standard care includes oxygen, nebulization, steroids, and surgical airway if necessary.
Eligibility (key points) Inclusion: age 18-80; scheduled thyroid/neck surgery; pre-op fixed cords at midline/paramedian or glottic gap ≤ 3 mm OR ≥ 2 high-risk factors (bilateral neck re-entry, tumor near both RLNs, bilateral C + L lymph-node dissection, severe OSA AHI ≥ 30, BMI ≥ 30).
Exclusion: emergency surgery, existing tracheostomy, ventilator dependence, mask intolerance, pregnancy, inability to consent.
Outcomes and Assessments
- Airway status monitored continuously POD 0-2, then daily to POD 7.
- ABG, pulse oximetry, and flexible laryngoscopy performed per protocol schedule.
- Adverse events graded by CTCAE v5.0; DSMB halting rule: ≥ 3 grade 3 airway failures in any arm.
Statistical Methods Intention-to-treat for primary endpoint. Log-binomial regression with center as random effect to estimate risk ratios for each main effect and their interaction. Kaplan-Meier curves for "tracheostomy-free survival." Interim analysis at 50 % information using O'Brien-Fleming alpha-spending.
Regulatory Status Devices (ResMed AirCurve 10 ST; Philips A40) are FDA-cleared class II ventilators (510(k)); IRB classified study as non-significant-risk device research exempt from IDE under 21 CFR 812.2(b).
Data Sharing De-identified individual participant data and statistical code will be shared upon reasonable request 6 months after final publication.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two-by-two factorial randomized controlled trial testing the independent and combined effects of (A) 7-day pre-operative BiPAP training and (B) immediate post-extubation BiPAP support.
| Arm | Type | Receives |
|---|---|---|
| Training + Post-op BiPAP | Experimental | Device: Post-extubation BiPAP Support, Other: Standard Peri-operative CareParticipants receive 7-day Pre-operative BiPAP Training and Post-extubation BiPAP Support for ≥ 48 h after surgery. |
| Training Only | Experimental | Other: Standard Peri-operative CareParticipants receive 7-day Pre-operative BiPAP Training. No routine BiPAP after extubation; peri-operative care otherwise standard. |
| Post-op BiPAP Only | Experimental | Device: Pre-operative BiPAP Training, Device: Post-extubation BiPAP SupportNo pre-op training. BiPAP started immediately after extubation and continued ≥ 48 h. |
| Standard Care | Active comparator | Device: Pre-operative BiPAP Training, Other: Standard Peri-operative CareNo planned BiPAP. Airway managed with institutional standard care only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 - 80 years.
- Scheduled for thyroidectomy or other neck surgery under general anesthesia.
- High risk of bilateral vocal-cord paralysis (BVCP) defined by at least ONE of:
- Able to tolerate and give informed consent for BiPAP mask use.
Key exclusion criteria (6 listed)
- Emergency surgery or need for immediate tracheostomy.
- Existing tracheostomy or home ventilator dependence.
- Inability to protect airway (e.g., Glasgow Coma Scale < 13).
- Craniofacial anomaly or skin condition precluding mask seal.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative BiPAP TrainingSeven consecutive nights (≥ 4 h/night) of BiPAP use at home or on ward, pressure ladder EPAP 6→8 cmH₂O / IPAP 12→16 cmH₂O, recorded on SD card; devices: ResMed AirCurve 10 ST or Philips A40. | Device | Post-op BiPAP Only, Standard Care |
| Post-extubation BiPAP SupportSame BiPAP device started immediately after tracheal extubation; EPAP 8 cmH₂O / IPAP 14 cmH₂O (or patient's final training setting) maintained ≥ 48 h, then weaned when SpO₂ ≥ 94 % off-BiPAP for 24 h. | Device | Post-op BiPAP Only, Training + Post-op BiPAP |
| Standard Peri-operative CareRoutine oxygen, nebulized steroids, airway monitoring; rescue re-intubation or tracheostomy per institutional protocol; no planned BiPAP unless crossover criteria met. | Other | Standard Care, Training + Post-op BiPAP, Training Only |
Primary outcome
Composite "Airway Failure" (Tracheostomy OR Re-intubation)
Time frame: The first occurrence of (a) surgical tracheostomy or (b) endotracheal re-intubation for respiratory distress within 7 days after extubation. Event status adjudicated by an independent investigator using pre-defined criteria.
Post-operative Day 0 through Day 7
5 secondary outcomes
Total BiPAP Usage Hours
Time frame: Post-op Day 0 to Day 2 (48 hours)
Hypoxemic Episodes (SpO₂ < 90 % ≥ 3 min)
Time frame: Post-op Day 0 to Day 2
ICU Length of Stay
Time frame: Surgery end → ICU discharge (up to 7 days)
Voice Handicap Index-10 (VHI-10)
Time frame: 6 months (±14 days) post-op
Normalized Glottic Area (NGA %)
Time frame: Baseline pre-op and 6 months post-op
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 29 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement
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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.
Bo WANG, MD principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative BiPAP Training, Post-extubation BiPAP Support and Standard Peri-operative Care in people with Vocal Cord Paralysis, Bilateral and Airway Obstruction, Postoperative, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 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: opening soon, as of the sponsor's last update on 29 Jun 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 China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo WANG, MD (+8613959123550, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite "Airway Failure" (Tracheostomy OR Re-intubation) (time frame: The first occurrence of (a) surgical tracheostomy or (b) endotracheal re-intubation for respiratory distress within 7 days after extubation. Event status adjudicated by an independent investigator using pre-defined criteria.). 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 29 Jun 2025.