Pleural EffusionCOSINENCT05945043
Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion
An observational study of Pleural Effusion, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to better understand the relationship between pleural effusions and breathlessness in patients with unilateral pleural effusions and breathlessness who require pleural fluid removal for its management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Surface parasternal eletromyogram, Surface diaphragm electromyogram and Parasternal muscle ultrasound
- How many people
- 124 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with unilateral pleural effusions requiring pleural fluid removal via thoracocentesis, chest drain insertion or IPC drainage for management of their breathlessness.
Who may be able to join
- Age 18 years or above
- Has a unilateral pleural effusion AND
- require thoracocentesis OR
- chest drain insertion (main study only) OR
- has an IPC in situ (main study only)
Who cannot join
- Inability to consent
- Any contraindications to the proposed pleural procedure
- Haemodynamic or clinical instability that precludes from the safe completion of required pre-procedural measurements
- Inability to identify surface landmarks for surface EMG electrode placement
- Past medical history of diaphragmatic paralysis (diaphragm sub study only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's & St Thomas' NHS Foundation Trust
London, London, SE1 9RT
Gill Radcliffe, 02071888070, gillian.radcliffe@gstt.nhs.uk
About this study
Official title: Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion (COSINE)
The aim of this study is to better understand the relationship between pleural effusions and breathlessness in patients with unilateral pleural effusions and breathlessness who require pleural fluid removal for its management.
Read the detailed description
This study will involve 124 adult patients who are breathlessness with pleural effusions. They will be recruited from a single UK centre over an 18-month period.
After being informed about the study, all patients giving written informed consent will undergo a baseline assessment when they first come to have their fluid drained. The investigators will record information about them and their disease. The investigators will take measurements of their breathlessness, their breathing muscles, and the electrical activity from the brain to those muscles. These will be taken at the start and end of drainage, as well as 1 day and 7 days after. The investigators will use this information to look for links between the effect of pleural effusions and its removal on the electrical activities of the breathing muscles and patients' breathlessness.
- Conditions
- Pleural Effusion
- Being tested
- Surface parasternal eletromyogram, Surface diaphragm electromyogram, Parasternal muscle ultrasound, Breathlessness assessment
- Keywords
- Pleural effusion, Breathlessness, Neural respiratory drive, Neurophysiology
- Medical subject headings
- Pleural Effusion, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface parasternal eletromyogramOther
The surface parasternal EMG of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal
Surface diaphragm electromyogramOther
The ipsilateral and contralateral surface diaphragm EMG of participants will be measured pre and immediately post pleural fluid removal
Parasternal muscle ultrasoundOther
The thickness of the parasternal intercostal muscle of participants will be measured using thoracic ultrasound pre and immediately post pleural fluid removal
Breathlessness assessmentOther
The VAS breathlessness score and Dyspnoea-12 questionnaire of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic pleural effuion | Patients with symptomatic unilateral pleural effusion of any cause who will be undergoing pleural fluid removal via thoracocentesis, chest drain insertion or IPC drainage for relief of their breathlessness. Receives: Other: Surface parasternal eletromyogram; Other: Surface diaphragm electromyogram; Other: Parasternal muscle ultrasound; Other: Breathlessness assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural respiratory drive (as measured by surface parasternal EMG) at 24 hours post pleural fluid removal
Neural respiratory drive index (as measured by surface parasternal EMG)
Measured: 24 hours
Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal
VAS dyspnoea score
Measured: 24 hours
Secondary outcomes (10)
Neural respiratory drive (as measured by surface parasternal EMG) at other time points post pleural fluid removal
Neural respiratory drive index (as measured by surface parasternal EMG)
Measured: pre procedure, immediately post procedure and daily up to 7 days
Patient reported breathlessness (as measured by VAS dyspnoea score) at other time points post pleural fluid removal
VAS dyspnoea score
Measured: pre procedure, immediately post procedure and daily up to and 7 days
The effect on exercise capacity of pleural fluid removal.
6 min walk test
Measured: pre procedure, immediately post procedure, 1 day and 7 days
Pleural effusion characteristics as measured by thoracic ultrasound
Thoracic ultrasound
Measured: immediately post procedure, 1 day and 7 days
To determine the acceptability of incorporating surface parasternal EMG measurement as part of routine clinical practice to patients and clinicians
Qualitative feedback form
Measured: peri-procedural
Neural respiratory drive (as measured by surface diaphragm EMG) of the ipsilateral hemidiaphragm following thoracocentesis
Neural respiratory drive index (as measured by surface diaphragm EMG)
Measured: peri-procedural
Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.
Thoracic ultrasound
Measured: peri-procedural
Neural respiratory drive (as measured by surface diaphragm EMG) of the contralateral hemidiaphragm following thoracocentesis
Neural respiratory drive index (as measured by surface diaphragm EMG)
Measured: peri-procedural
Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.
Thoracic ultrasound
Measured: peri-procedural
Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal
Thoracic ultrasound
Measured: peri-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start15 Nov 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Murphy, MBBS BSc, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945043
- Sponsor's protocol ID
- 322762
- Acronym
- COSINE
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhatnagar R, Maskell N. The modern diagnosis and management of pleural effusions. BMJ. 2015 Sep 8;351:h4520. doi: 10.1136/bmj.h4520. No abstract available.
PubMed 26350935Marel M, Zrustova M, Stasny B, Light RW. The incidence of pleural effusion in a well-defined region. Epidemiologic study in central Bohemia. Chest. 1993 Nov;104(5):1486-9. doi: 10.1378/chest.104.5.1486.
PubMed 8222812Thomas R, Jenkins S, Eastwood PR, Lee YC, Singh B. Physiology of breathlessness associated with pleural effusions. Curr Opin Pulm Med. 2015 Jul;21(4):338-45. doi: 10.1097/MCP.0000000000000174.
PubMed 25978627Estenne M, Yernault JC, De Troyer A. Mechanism of relief of dyspnea after thoracocentesis in patients with large pleural effusions. Am J Med. 1983 May;74(5):813-9. doi: 10.1016/0002-9343(83)91072-0.
PubMed 6837605Psallidas I, Yousuf A, Talwar A, Hallifax RJ, Mishra EK, Corcoran JP, Ali N, Rahman NM. Assessment of patient-reported outcome measures in pleural interventions. BMJ Open Respir Res. 2017 Jul 3;4(1):e000171. doi: 10.1136/bmjresp-2016-000171. eCollection 2017.
PubMed 28883922Muruganandan S, Azzopardi M, Thomas R, Fitzgerald DB, Kuok YJ, Cheah HM, Read CA, Budgeon CA, Eastwood PR, Jenkins S, Singh B, Murray K, Lee YCG. The Pleural Effusion And Symptom Evaluation (PLEASE) study of breathlessness in patients with a symptomatic pleural effusion. Eur Respir J. 2020 May 14;55(5):1900980. doi: 10.1183/13993003.00980-2019. Print 2020 May.
PubMed 32079642Nishino T. Dyspnoea: underlying mechanisms and treatment. Br J Anaesth. 2011 Apr;106(4):463-74. doi: 10.1093/bja/aer040. Epub 2011 Mar 4.
PubMed 21378105Light RW, Stansbury DW, Brown SE. The relationship between pleural pressures and changes in pulmonary function after therapeutic thoracentesis. Am Rev Respir Dis. 1986 Apr;133(4):658-61. doi: 10.1164/arrd.1986.133.4.658.
PubMed 3963629Skaarup SH, Lonni S, Quadri F, Valsecchi A, Ceruti P, Marchetti G. Ultrasound Evaluation of Hemidiaphragm Function Following Thoracentesis: A Study on Mechanisms of Dyspnea Related to Pleural Effusion. J Bronchology Interv Pulmonol. 2020 Jul;27(3):172-178. doi: 10.1097/LBR.0000000000000627.
PubMed 31651544Fitzgerald DB, Muruganandan S, Peddle-McIntyre CJ, Lee YCG, Singh B. Ipsilateral and contralateral hemidiaphragm dynamics in symptomatic pleural effusion: The 2nd PLeural Effusion And Symptom Evaluation (PLEASE-2) Study. Respirology. 2022 Oct;27(10):882-889. doi: 10.1111/resp.14307. Epub 2022 Jun 7.
PubMed 35672271De Troyer A, Kirkwood PA, Wilson TA. Respiratory action of the intercostal muscles. Physiol Rev. 2005 Apr;85(2):717-56. doi: 10.1152/physrev.00007.2004.
PubMed 15788709Decramer M. Hyperinflation and respiratory muscle interaction. Eur Respir J. 1997 Apr;10(4):934-41.
PubMed 9150337Jolley CJ, Moxham J. A physiological model of patient-reported breathlessness during daily activities in COPD. Eur Respir Rev. 2009 Jun;18(112):66-79. doi: 10.1183/09059180.00000809.
PubMed 20956127Finucane KE, Panizza JA, Singh B. Efficiency of the normal human diaphragm with hyperinflation. J Appl Physiol (1985). 2005 Oct;99(4):1402-11. doi: 10.1152/japplphysiol.01165.2004. Epub 2005 Jun 16.
PubMed 15961606De Troyer A, Wilson TA. Effect of acute inflation on the mechanics of the inspiratory muscles. J Appl Physiol (1985). 2009 Jul;107(1):315-23. doi: 10.1152/japplphysiol.91472.2008. Epub 2009 Mar 5.
PubMed 19265064
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion (COSINE)
- ClinicalTrials.gov ID
- NCT05945043
- Acronym / sponsor ID
- COSINE / 322762
- Conditions
- Pleural Effusion
- Keywords
- Pleural effusion, Breathlessness, Neural respiratory drive, Neurophysiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Jul 2023 (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 aim of this study is to better understand the relationship between pleural effusions and breathlessness in patients with unilateral pleural effusions and breathlessness who require pleural fluid removal for its management.
Detailed description
This study will involve 124 adult patients who are breathlessness with pleural effusions. They will be recruited from a single UK centre over an 18-month period.
After being informed about the study, all patients giving written informed consent will undergo a baseline assessment when they first come to have their fluid drained. The investigators will record information about them and their disease. The investigators will take measurements of their breathlessness, their breathing muscles, and the electrical activity from the brain to those muscles. These will be taken at the start and end of drainage, as well as 1 day and 7 days after. The investigators will use this information to look for links between the effect of pleural effusions and its removal on the electrical activities of the breathing muscles and patients' breathlessness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic pleural effuion | – | Other: Surface parasternal eletromyogram, Other: Surface diaphragm electromyogram, Other: Parasternal muscle ultrasound, Other: Breathlessness assessmentPatients with symptomatic unilateral pleural effusion of any cause who will be undergoing pleural fluid removal via thoracocentesis, chest drain insertion or IPC drainage for relief of their breathlessness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with unilateral pleural effusions requiring pleural fluid removal via thoracocentesis, chest drain insertion or IPC drainage for management of their breathlessness.
Key inclusion criteria (5 listed)
- Age 18 years or above
- Has a unilateral pleural effusion AND
Key exclusion criteria (5 listed)
- Inability to consent
- Any contraindications to the proposed pleural procedure
- Haemodynamic or clinical instability that precludes from the safe completion of required pre-procedural measurements
- Inability to identify surface landmarks for surface EMG electrode placement
- Past medical history of diaphragmatic paralysis (diaphragm sub study only)
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 |
|---|---|---|
| Surface parasternal eletromyogramThe surface parasternal EMG of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal | Other | Symptomatic pleural effuion |
| Surface diaphragm electromyogramThe ipsilateral and contralateral surface diaphragm EMG of participants will be measured pre and immediately post pleural fluid removal | Other | Symptomatic pleural effuion |
| Parasternal muscle ultrasoundThe thickness of the parasternal intercostal muscle of participants will be measured using thoracic ultrasound pre and immediately post pleural fluid removal | Other | Symptomatic pleural effuion |
| Breathlessness assessmentThe VAS breathlessness score and Dyspnoea-12 questionnaire of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal | Other | Symptomatic pleural effuion |
Primary outcome
Neural respiratory drive (as measured by surface parasternal EMG) at 24 hours post pleural fluid removal
Time frame: 24 hours
Neural respiratory drive index (as measured by surface parasternal EMG)
Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal
Time frame: 24 hours
VAS dyspnoea score
10 secondary outcomes
Neural respiratory drive (as measured by surface parasternal EMG) at other time points post pleural fluid removal
Time frame: pre procedure, immediately post procedure and daily up to 7 days
Patient reported breathlessness (as measured by VAS dyspnoea score) at other time points post pleural fluid removal
Time frame: pre procedure, immediately post procedure and daily up to and 7 days
The effect on exercise capacity of pleural fluid removal.
Time frame: pre procedure, immediately post procedure, 1 day and 7 days
Pleural effusion characteristics as measured by thoracic ultrasound
Time frame: immediately post procedure, 1 day and 7 days
To determine the acceptability of incorporating surface parasternal EMG measurement as part of routine clinical practice to patients and clinicians
Time frame: peri-procedural
Neural respiratory drive (as measured by surface diaphragm EMG) of the ipsilateral hemidiaphragm following thoracocentesis
Time frame: peri-procedural
Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.
Time frame: peri-procedural
Neural respiratory drive (as measured by surface diaphragm EMG) of the contralateral hemidiaphragm following thoracocentesis
Time frame: peri-procedural
Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.
Time frame: peri-procedural
Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal
Time frame: peri-procedural
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 4 Jun 2026.
- Results publication: PubMed 26350935Bhatnagar R, Maskell N. The modern diagnosis and management of pleural effusions. BMJ. 2015 Sep 8;351:h4520. doi: 10.1136/bmj.h4520. No abstract available.
- Results publication: PubMed 8222812Marel M, Zrustova M, Stasny B, Light RW. The incidence of pleural effusion in a well-defined region. Epidemiologic study in central Bohemia. Chest. 1993 Nov;104(5):1486-9. doi: 10.1378/chest.104.5.1486.
- Results publication: PubMed 25978627Thomas R, Jenkins S, Eastwood PR, Lee YC, Singh B. Physiology of breathlessness associated with pleural effusions. Curr Opin Pulm Med. 2015 Jul;21(4):338-45. doi: 10.1097/MCP.0000000000000174.
- Results publication: PubMed 6837605Estenne M, Yernault JC, De Troyer A. Mechanism of relief of dyspnea after thoracocentesis in patients with large pleural effusions. Am J Med. 1983 May;74(5):813-9. doi: 10.1016/0002-9343(83)91072-0.
- Results publication: PubMed 28883922Psallidas I, Yousuf A, Talwar A, Hallifax RJ, Mishra EK, Corcoran JP, Ali N, Rahman NM. Assessment of patient-reported outcome measures in pleural interventions. BMJ Open Respir Res. 2017 Jul 3;4(1):e000171. doi: 10.1136/bmjresp-2016-000171. eCollection 2017.
- Results publication: PubMed 32079642Muruganandan S, Azzopardi M, Thomas R, Fitzgerald DB, Kuok YJ, Cheah HM, Read CA, Budgeon CA, Eastwood PR, Jenkins S, Singh B, Murray K, Lee YCG. The Pleural Effusion And Symptom Evaluation (PLEASE) study of breathlessness in patients with a symptomatic pleural effusion. Eur Respir J. 2020 May 14;55(5):1900980. doi: 10.1183/13993003.00980-2019. Print 2020 May.
- Results publication: PubMed 21378105Nishino T. Dyspnoea: underlying mechanisms and treatment. Br J Anaesth. 2011 Apr;106(4):463-74. doi: 10.1093/bja/aer040. Epub 2011 Mar 4.
- Results publication: PubMed 3963629Light RW, Stansbury DW, Brown SE. The relationship between pleural pressures and changes in pulmonary function after therapeutic thoracentesis. Am Rev Respir Dis. 1986 Apr;133(4):658-61. doi: 10.1164/arrd.1986.133.4.658.
- Results publication: PubMed 31651544Skaarup SH, Lonni S, Quadri F, Valsecchi A, Ceruti P, Marchetti G. Ultrasound Evaluation of Hemidiaphragm Function Following Thoracentesis: A Study on Mechanisms of Dyspnea Related to Pleural Effusion. J Bronchology Interv Pulmonol. 2020 Jul;27(3):172-178. doi: 10.1097/LBR.0000000000000627.
- Results publication: PubMed 35672271Fitzgerald DB, Muruganandan S, Peddle-McIntyre CJ, Lee YCG, Singh B. Ipsilateral and contralateral hemidiaphragm dynamics in symptomatic pleural effusion: The 2nd PLeural Effusion And Symptom Evaluation (PLEASE-2) Study. Respirology. 2022 Oct;27(10):882-889. doi: 10.1111/resp.14307. Epub 2022 Jun 7.
- Results publication: PubMed 15788709De Troyer A, Kirkwood PA, Wilson TA. Respiratory action of the intercostal muscles. Physiol Rev. 2005 Apr;85(2):717-56. doi: 10.1152/physrev.00007.2004.
- Results publication: PubMed 9150337Decramer M. Hyperinflation and respiratory muscle interaction. Eur Respir J. 1997 Apr;10(4):934-41.
- Individual participant dataSharing planned: No
Related trials for Pleural Effusion
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
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.
Patrick Murphy, MBBS BSc principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 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 1 site in United Kingdom. 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 Junyi Zhang, MBBChir (02071887188 ext. 56122, junyi.zhang@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural respiratory drive (as measured by surface parasternal EMG) at 24 hours post pleural fluid removal (time frame: 24 hours). 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 NCT05945043, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.