Pleural EffusionNCT06099054
Ultrasound-guided Pigtail Catheter Versus Intercostal Tube Drainage of Non-traumatic Exudative Pleural Effusion
A study testing Pigtail catheter and Intercostal tube in people with Pleural Effusion, run by Assiut University.
Trial summary
Primary Aims: To compare the performance of pigtail catheter to that of ICT in drainage of pleural effusion of medical aetiology regarding: 1. Various complications(mainly wound pain) that result from either therapeutic approach. 2. Success of complete drainage. 3. Compare the duration needed for complete drainage. 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?
- Pigtail catheter and Intercostal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 25 May 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Non-traumatic non-iatrogenic exudative pleural effusion necessitating drainage.
- Loculated pleural effusion where positive colour doppler sign is preserved
Who cannot join
- Traumatic or iatrogenic pleural effusion.
- Transudative pleural effusion (subjected to treatment of the underlying cause and diuretic therapy).
- Exudative pleural effusion amenable for medical treatment
- Large-volume, easily accessible, free non-loculated empyema.
- Pleural infections with loculated pleural effusion but showing negative colour doppler sign.
- Malignant pleural effusion with potentially inexpnasible underlying lung (thick pleural peel, central airway obstruction), life expectancy < 1 month or asymptomatic.
- Patients with uncorrected bleeding tendency (INR > 1.5, Platelet count < 50.000/mm3).
- Inability or refusal to sign written consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Primary Aims:
To compare the performance of pigtail catheter to that of ICT in drainage of pleural effusion of medical aetiology regarding:
- Various complications(mainly wound pain) that result from either therapeutic approach.
- Success of complete drainage.
- Compare the duration needed for complete drainage.
Secondary Aims:
To evaluate both techniques in terms of:
- Degree of patient's mobility that either technique permits.
- Percentage of patients that can be managed on outpatient settings by either approach
Read the detailed description
The pleural cavity is a space between the visceral and parietal pleura that contains a subtle amount of serous fluid (10 to 20ml) this fluid act as a lubricant to the pleural surface for proper gliding during respiration . Accumulation of abnormal amount of pleural fluid occurs under various pathological disorders, each of which manifests with a different physical and biochemical characteristics of the effused pleural fluid, it may be serous,pus,blood,or chyle.
Long standing undrained accumulated pleural fluid can lead to serious complications: like lung collapse leading to respiratory failure, fibrosis or scarring of the pleural membranes and underlying lung tissue, empyema, septic shock and even death in severe circumstance .
So we always seek to drain accumulated pleural fluid; Chest tubes connected to underwater seal have largely replaced open thoracotomy and rib resection in draining exudative pleural effusion and are now considered the standard method . However Intercostal tube drainage poses risks and hazards: large size of the tube that make it more painful more tissue destructive with more injury to intercostal arteries and nerves, the incisional insertion is also painful and results in more tissue dissection, moreover the tube is heavy as it need water seal to work so causing patient discomfort and increase liability of slippage.
Recently pigtail catheter has been employed to drain accumulated pleural fluid .pigtail catheter has many advantages: it has small caliber , which makes it less painful, less tissue destruction, less Injurious to intercostal nerves and vessels, Additionally it has a suction power with unidirectional valve which abolishes the need for underwater seal; thus avoiding the heavy weight of bottles and decreasing the risk of accidental slippage, inserted with trocar under ultrasonographic guidance decreasing liability of lung injury.
Previous studies compared pigtail versus chest tube in drainage of pleural effusion show .A total of 92 patients were included in the study, 57 (61.9%) patients in pigtail group and 35 (31.8%) in ICD group. Causes of pleural effusion included were pneumonia, malignancy,TB. the study had revealed that pigtail catheter had higher success rate less painful with no significant difference at mean duration of drainage..At other study data collected retrospectively from 60 patient aged more than 18 year 30 patients had an intercostal chest tube and 30 patients had pigtail catheters found that no statistically significant difference between pigtail and ICT at success rate and duration of drainage but pigtail found less painful with less incidence of complication regarding pneumothorax and catheter kinking and slippage .
However these studies have some limations first study was observational study not randomised, second study was retrospective with small sample size. Both studies have no clear definitions of outcomes , not focus on complications mainly wound pain as primary outcome and didn't answer the question of recurrence or drainage failure of pleural effusion after pigtail catheter drainage.
- Conditions
- Pleural Effusion
- Being tested
- Pigtail catheter, Intercostal tube
- Keywords
- pigtail versus intercostal tube
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pigtail catheterDevice
Pigtail catheter will be inserted using Seldinger technique under US guidance to drainage exudative pleural effusion by a trained radiologist
Intercostal tubeDevice
Chest tube will be inserted according to BTS guideline for insertion of ICT by a trained thoracic surgeon
| Study group | Role | What they receive |
|---|---|---|
| pigtail group | Experimental | composed of 40 patients in which pleural effusion will be drained using pigtail catheter under US guidance Receives: Device: Pigtail catheter |
| ICT group | Active comparator | composed of 40 patients in which pleural effusion will be drained using ICT Receives: Device: Intercostal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Degree of Pain/discomfort elicited by the Intervention:
The visual analogue Scale from 0 TO 10 will be used to score reported pain or discomfort
Measured: 10 day
2) Adverse outcomes complicating either line of intervention
(e.g., new onset pneumothorax or haemothorax, subcutaneous emphysema, fluid leakage around the wound, organ puncture, re-expansion pulmonary oedema, pneumonia, blockade of the drain, kinking or malposition).
Measured: through study completion, an average of 1 year
3) Success of Complete Drainage
Number of patients with complete drainage:
Complete drainage will be considered if all the following conditions are met:
Amount of drained fluid < 50 cc of serous/ hemo-serous fluid (no pus or gross bleeding) for two successive days.
No accompanying air leak in the previous 12 hours. Radiological resolution (no residual free pleural fluid seen by chest US and lung expansion against chest wall as detected by chest US and CXR)
Measured: through study completion, an average of 1 year
4) Duration needed for Complete Drainage:
Duration (in days) will be counted from the day of drain insertion to the day of drain removal
Measured: 15 day
Secondary outcomes (3)
5) Degree of Patient's Mobility:
A modification of a 6-item survey assessing the patient's sense of security with a chest drain will be used. Patients are to be asked to report:
- How confident they are moving with the chest drain without limitation in activities.
- How confident they are moving with the chest drain without concerns about accidental slippage/removal of the drainage set.
- How confident they are moving with the chest drain without concerns about accidental damage/breakage to the drainage set.
Patients are to report their answer to this question on a 5-point Likert's scale, where 5 meant "definitely yes" and 1 meant "definitely not".
Measured: 0ne week
6) Duration of Hospital stay.
number of patients need hospitalization and duration they will spend at hospital
Measured: "through study completion, an average of 1 year
7) Number of Patients Managed on Outpatient Settings.
Measured: "through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion25 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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 Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to either group: Group I (Intervention group): in which pleural effusion will be drained using pigtail catheter under US guidance. Group II (Control group): in which pleural effusion will be drained using ICT
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Hassan Sayed, Assiut University
- Investigators
- Hossam El-din Galal, Prof.Dr, Principal investigator, Assiut UniveristyHamdy Mohammad Ibrahim, lecturer, Study director, Assiut UniveristySara Mohammed Hashem, lecturer, Study director, Assiut Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099054
- Sponsor's protocol ID
- Pigtail versus ICT
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chubb SP, Williams RA. Biochemical Analysis of Pleural Fluid and Ascites. Clin Biochem Rev. 2018 May;39(2):39-50.
PubMed 30473591Karkhanis VS, Joshi JM. Pleural effusion: diagnosis, treatment, and management. Open Access Emerg Med. 2012 Jun 22;4:31-52. doi: 10.2147/OAEM.S29942. eCollection 2012.
PubMed 27147861Broaddus VC, Light RW. Pleural effusion. In:Broaddus VC, Ernst JD, King TE, et al, eds. Murray and Nadel's Textbook of Respiratory Medicine. 7th ed. Philadelphia, PA: Elsevier; 2022:chapater108
Monaghan SF, Swan KG. Tube thoracostomy: the struggle to the "standard of care". Ann Thorac Surg. 2008 Dec;86(6):2019-22. doi: 10.1016/j.athoracsur.2008.08.006.
PubMed 19022041Munnell ER. Thoracic drainage. Ann Thorac Surg. 1997 May;63(5):1497-502. doi: 10.1016/s0003-4975(97)00082-9.
PubMed 9146363Liu YH, Lin YC, Liang SJ, Tu CY, Chen CH, Chen HJ, Chen W, Shih CM, Hsu WH. Ultrasound-guided pigtail catheters for drainage of various pleural diseases. Am J Emerg Med. 2010 Oct;28(8):915-21. doi: 10.1016/j.ajem.2009.04.041. Epub 2010 Feb 25.
PubMed 20825924Gammie JS, Banks MC, Fuhrman CR, Pham SM, Griffith BP, Keenan RJ, Luketich JD. The pigtail catheter for pleural drainage: a less invasive alternative to tube thoracostomy. JSLS. 1999 Jan-Mar;3(1):57-61.
PubMed 10323171Khare R*, Anand K, Agrawal P, Yadav A. Comparative analysis of pigtail catheter versus intercostal tube drainage for pleural effusion: a tertiary centre study. Khare R et al. Int Surg J. 2023 Jan;10(1):105-109
Mathis G. Pleura. In: Mathis G, ed. Chest sonography. 3rd ed. Heidelberg: Springer-Verlag, 2011;30-32
Yang PC, Luh KT, Chang DB, Wu HD, Yu CJ, Kuo SH. Value of sonography in determining the nature of pleural effusion: analysis of 320 cases. AJR Am J Roentgenol. 1992 Jul;159(1):29-33. doi: 10.2214/ajr.159.1.1609716.
PubMed 1609716Reuß J., "Sonographic imaging of the pleura: Nearly 30 years experience," European Journal of Ultrasound, vol. 3, no. 2, pp. 125-139, 1996.
SELDINGER SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol (Stockh). 1953 May;39(5):368-76. doi: 10.3109/00016925309136722. No abstract available.
PubMed 13057644Laws D, Neville E, Duffy J; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the insertion of a chest drain. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii53-9. doi: 10.1136/thorax.58.suppl_2.ii53. No abstract available.
PubMed 12728150Fox V, Gould D, Davies N, Owen S. Patients' experiences of having an underwater seal chest drain: a replication study. J Clin Nurs. 1999 Nov;8(6):684-92. doi: 10.1046/j.1365-2702.1999.00307.x.
PubMed 10827615
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Pigtail Catheter Versus Intercostal Tube Drainage of Non-traumatic Exudative Pleural Effusion
- ClinicalTrials.gov ID
- NCT06099054
- Acronym / sponsor ID
- Pigtail versus ICT
- Conditions
- Pleural Effusion
- Keywords
- pigtail versus intercostal tube
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 25 May 2028 (estimated)
- First posted
- 25 Oct 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.
Primary Aims:
To compare the performance of pigtail catheter to that of ICT in drainage of pleural effusion of medical aetiology regarding:
- Various complications(mainly wound pain) that result from either therapeutic approach.
- Success of complete drainage.
- Compare the duration needed for complete drainage.
Secondary Aims:
To evaluate both techniques in terms of:
- Degree of patient's mobility that either technique permits.
- Percentage of patients that can be managed on outpatient settings by either approach
Detailed description
The pleural cavity is a space between the visceral and parietal pleura that contains a subtle amount of serous fluid (10 to 20ml) this fluid act as a lubricant to the pleural surface for proper gliding during respiration . Accumulation of abnormal amount of pleural fluid occurs under various pathological disorders, each of which manifests with a different physical and biochemical characteristics of the effused pleural fluid, it may be serous,pus,blood,or chyle.
Long standing undrained accumulated pleural fluid can lead to serious complications: like lung collapse leading to respiratory failure, fibrosis or scarring of the pleural membranes and underlying lung tissue, empyema, septic shock and even death in severe circumstance .
So we always seek to drain accumulated pleural fluid; Chest tubes connected to underwater seal have largely replaced open thoracotomy and rib resection in draining exudative pleural effusion and are now considered the standard method . However Intercostal tube drainage poses risks and hazards: large size of the tube that make it more painful more tissue destructive with more injury to intercostal arteries and nerves, the incisional insertion is also painful and results in more tissue dissection, moreover the tube is heavy as it need water seal to work so causing patient discomfort and increase liability of slippage.
Recently pigtail catheter has been employed to drain accumulated pleural fluid .pigtail catheter has many advantages: it has small caliber , which makes it less painful, less tissue destruction, less Injurious to intercostal nerves and vessels, Additionally it has a suction power with unidirectional valve which abolishes the need for underwater seal; thus avoiding the heavy weight of bottles and decreasing the risk of accidental slippage, inserted with trocar under ultrasonographic guidance decreasing liability of lung injury.
Previous studies compared pigtail versus chest tube in drainage of pleural effusion show .A total of 92 patients were included in the study, 57 (61.9%) patients in pigtail group and 35 (31.8%) in ICD group. Causes of pleural effusion included were pneumonia, malignancy,TB. the study had revealed that pigtail catheter had higher success rate less painful with no significant difference at mean duration of drainage..At other study data collected retrospectively from 60 patient aged more than 18 year 30 patients had an intercostal chest tube and 30 patients had pigtail catheters found that no statistically significant difference between pigtail and ICT at success rate and duration of drainage but pigtail found less painful with less incidence of complication regarding pneumothorax and catheter kinking and slippage .
However these studies have some limations first study was observational study not randomised, second study was retrospective with small sample size. Both studies have no clear definitions of outcomes , not focus on complications mainly wound pain as primary outcome and didn't answer the question of recurrence or drainage failure of pleural effusion after pigtail catheter drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomised to either group: Group I (Intervention group): in which pleural effusion will be drained using pigtail catheter under US guidance. Group II (Control group): in which pleural effusion will be drained using ICT
| Arm | Type | Receives |
|---|---|---|
| pigtail group | Experimental | Device: Pigtail cathetercomposed of 40 patients in which pleural effusion will be drained using pigtail catheter under US guidance |
| ICT group | Active comparator | Device: Intercostal tubecomposed of 40 patients in which pleural effusion will be drained using ICT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years.
- Non-traumatic non-iatrogenic exudative pleural effusion necessitating drainage.
- Loculated pleural effusion where positive colour doppler sign is preserved
Key exclusion criteria (8 listed)
- Traumatic or iatrogenic pleural effusion.
- Transudative pleural effusion (subjected to treatment of the underlying cause and diuretic therapy).
- Exudative pleural effusion amenable for medical treatment
- Large-volume, easily accessible, free non-loculated empyema.
- Pleural infections with loculated pleural effusion but showing negative colour doppler sign.
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 |
|---|---|---|
| Pigtail catheterPigtail catheter will be inserted using Seldinger technique under US guidance to drainage exudative pleural effusion by a trained radiologist | Device | pigtail group |
| Intercostal tubeChest tube will be inserted according to BTS guideline for insertion of ICT by a trained thoracic surgeon | Device | ICT group |
Primary outcome
1) Degree of Pain/discomfort elicited by the Intervention:
Time frame: 10 day
The visual analogue Scale from 0 TO 10 will be used to score reported pain or discomfort
2) Adverse outcomes complicating either line of intervention
Time frame: through study completion, an average of 1 year
(e.g., new onset pneumothorax or haemothorax, subcutaneous emphysema, fluid leakage around the wound, organ puncture, re-expansion pulmonary oedema, pneumonia, blockade of the drain, kinking or malposition).
3) Success of Complete Drainage
Time frame: through study completion, an average of 1 year
Number of patients with complete drainage: Complete drainage will be considered if all the following conditions are met: Amount of drained fluid < 50 cc of serous/ hemo-serous fluid (no pus or gross bleeding) for two successive days. No accompanying air leak in the previous 12 hours. Radiological resolution (no residual free pleural fluid seen by chest US and lung expansion against chest wall as detected by chest US and CXR)
4) Duration needed for Complete Drainage:
Time frame: 15 day
Duration (in days) will be counted from the day of drain insertion to the day of drain removal
3 secondary outcomes
5) Degree of Patient's Mobility:
Time frame: 0ne week
6) Duration of Hospital stay.
Time frame: "through study completion, an average of 1 year
7) Number of Patients Managed on Outpatient Settings.
Time frame: "through study completion, an average of 1 year
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 25 Oct 2023.
- Background: PubMed 30473591Chubb SP, Williams RA. Biochemical Analysis of Pleural Fluid and Ascites. Clin Biochem Rev. 2018 May;39(2):39-50.
- Background: PubMed 27147861Karkhanis VS, Joshi JM. Pleural effusion: diagnosis, treatment, and management. Open Access Emerg Med. 2012 Jun 22;4:31-52. doi: 10.2147/OAEM.S29942. eCollection 2012.
- BackgroundBroaddus VC, Light RW. Pleural effusion. In:Broaddus VC, Ernst JD, King TE, et al, eds. Murray and Nadel's Textbook of Respiratory Medicine. 7th ed. Philadelphia, PA: Elsevier; 2022:chapater108
- Background: PubMed 19022041Monaghan SF, Swan KG. Tube thoracostomy: the struggle to the "standard of care". Ann Thorac Surg. 2008 Dec;86(6):2019-22. doi: 10.1016/j.athoracsur.2008.08.006.
- Background: PubMed 9146363Munnell ER. Thoracic drainage. Ann Thorac Surg. 1997 May;63(5):1497-502. doi: 10.1016/s0003-4975(97)00082-9.
- Background: PubMed 20825924Liu YH, Lin YC, Liang SJ, Tu CY, Chen CH, Chen HJ, Chen W, Shih CM, Hsu WH. Ultrasound-guided pigtail catheters for drainage of various pleural diseases. Am J Emerg Med. 2010 Oct;28(8):915-21. doi: 10.1016/j.ajem.2009.04.041. Epub 2010 Feb 25.
- Background: PubMed 10323171Gammie JS, Banks MC, Fuhrman CR, Pham SM, Griffith BP, Keenan RJ, Luketich JD. The pigtail catheter for pleural drainage: a less invasive alternative to tube thoracostomy. JSLS. 1999 Jan-Mar;3(1):57-61.
- BackgroundKhare R*, Anand K, Agrawal P, Yadav A. Comparative analysis of pigtail catheter versus intercostal tube drainage for pleural effusion: a tertiary centre study. Khare R et al. Int Surg J. 2023 Jan;10(1):105-109
- BackgroundMathis G. Pleura. In: Mathis G, ed. Chest sonography. 3rd ed. Heidelberg: Springer-Verlag, 2011;30-32
- Background: PubMed 1609716Yang PC, Luh KT, Chang DB, Wu HD, Yu CJ, Kuo SH. Value of sonography in determining the nature of pleural effusion: analysis of 320 cases. AJR Am J Roentgenol. 1992 Jul;159(1):29-33. doi: 10.2214/ajr.159.1.1609716.
- BackgroundReuß J., "Sonographic imaging of the pleura: Nearly 30 years experience," European Journal of Ultrasound, vol. 3, no. 2, pp. 125-139, 1996.
- Background: PubMed 13057644SELDINGER SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol (Stockh). 1953 May;39(5):368-76. doi: 10.3109/00016925309136722. No abstract available.
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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.
Hossam El-din Galal, Prof.Dr principal investigator
Assiut Univeristy
Hamdy Mohammad Ibrahim, lecturer study director
Assiut Univeristy
Sara Mohammed Hashem, lecturer study director
Assiut Univeristy
Questions about this trial
What is this clinical trial studying?
A study testing Pigtail catheter and Intercostal tube in people with Pleural Effusion, run by Assiut University.
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 8 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 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Hossam Hassan, master (01008933979, hh6173303@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) Degree of Pain/discomfort elicited by the Intervention: (time frame: 10 day). The study lists 4 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 NCT06099054, which also lists 14 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 25 Oct 2023.