Hepatic HydrothoraxNCT06007820
Efficacy & Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax.
A study testing Large Volume Thoracocentesis and Pigtail Catheter in people with Hepatic Hydrothorax, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
In cirrhotic patients with recurrent hepatic hydrothorax liver transplantation is a definitive treatment. But a significant number of individual are ineligible for liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Hydrothorax
- What is being tested?
- Large Volume Thoracocentesis and Pigtail Catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- 15 Aug 2023to 27 Feb 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- CLD with refilling symptomatic hepatic hydrothorax
Who cannot join
- CTP >12, MELD>25
- Tubercular PE, Ischemic cardiac disease
- If opting for TIPS/ LT
- Severe HPS
- Prior or current SBE/ SBP, septic shock
- Patients on mechanical ventilator
Show all 16Show fewer
- Serum Creatinine >2 mg/dl
- Extrahepatic malignancy
- Serum Sodium < 120
- Post TIPS/ BRTO/ SAE patients
- Post renal or liver transplantation
- Lack of informed consent
- Hepatocellular carcinoma outside milan criteria
- Non-cirrhotic portal HT
- Known HIV infection
- Pregnant women
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr . Jaifrin Daniel, MD, 01146300000, jdaniel.m07@gmail.com
About this study
Official title: Efficacy & Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax. A Randomized Controlled Trial
In cirrhotic patients with recurrent hepatic hydrothorax liver transplantation is a definitive treatment. But a significant number of individual are ineligible for liver transplantation. In these patients to ameliorate the symptoms various treatment modalities such as TIPS, serial thoracocentesis, pigtail catheter drainage and pleurodesis are used. We are doing this study to assess the safety and efficacy of serial thoracocentesis verus pigtail catheter drainage.
Read the detailed description
- Study population - Cirrhotic patients with recurrent hepatic hydrothorax
- Study design - A prospective, randomized, single center open label study
- Block Randomization, block size - 10
- Sample size - Assuming in single time thoracocentesis group 5+/-3.67 thoracocentesis is required, investigator expect a 50 % reduction in pigtail drainage group. Apha error- 5, power -90, 15% dropout 35 patients in each arm
- Intervention - Group 1 - on-demand therapeutic thoracocentensis, Group 2 - small volume frequent thoracocentesis using PCD.
- Monitoring and assessment
- At enrollment: (A) Complete history and examination
- Etiology of cirrhosis
- Severity of ascites, Jaundice
- Prior Hepatic encephalopathy, bleed, Jaundice
- Prior Spontaneous bacterial peritonitis, large volume paracentesis frequency
- Pattern and number of prior decompensation
- Prior Acute on Chronic Liver Failure and Acute Kidney episodes
- Use of non selective beta blockers, norfloxaxin, rifaximin and albumin
- History of Endoscopic Variceal ligation or other endotherapy
- History of Hypertension, Diabetes
- Fever , signs of sepsis (SIRS)
- Examination- Sarcopenia, fraility, icterus, pedal edema
At follow-up (at daily till Day - 7, thereafter at Day - 30 and Day 90) Complete history and examination
- Complications - SBP, SBE, ACLF and Jaundice, HE/ AKI episodes
- HTN, Diabetes control
- Fever , signs of sepsis (SIRS)
- Examination- Sarcopenia, fraility, icterus, pedal edema, ascites, HE Clinical Evaluation
- Etiology of chronic liver disease (Baseline) 2. Severity of liver disease (Baseline, Day - 7, Day - 30, Day - 90 ) 3. MELD score, MELD-Na score, CTP score (Baseline, Day - 7, Day - 30, Day - 90 ) 4. Complications (Baseline, Day - 7, Day - 30, Day - 90 ) 5. Overt HE, PHT related Bleed, clinical jaundice, ascites, hyponatremia, AKI, SBP, Infection (specify site and severity), Frequency of Large Volume Paracentesis, On Demand Thoracocentesis
- Labs and follow up Baseline (at admission) -
- Blood : KFT, LFT, CBC, INR, AFP, PCT, S.PRA, Pro-BNP, Urinary Na
- Imaging : USG abdomen, X-ray chest, 2D ECHO
- Pleural fluid/ ascitic fluid - TLC, DLC, Protein, Sugar, SPAG, SAAG, ADA, c/s
- Hemodynamics : Intrapleural pressures at first TT
- Baseline (at randomization, Day -3 and Day - 7 in PCD-TT) -
- Blood : KFT, INR; S.PRA, Pro-BNP, Urinary Na (at Day 7)
- Imaging : X-ray chest
- Pleural fluid/ ascitic fluid - TLC, DLC, SPAG, c/s if indicated
- Day - 60, Day - 90 (end of follow-up)
- Blood : KFT, LFT, CBC, INR, AFP
- Imaging : USG abdomen, X-ray chest, 2D ECHO
- STATISTICAL ANALYSIS -
- Data will be reported as mean + SD.
- Categorical variables will be compared using the chi-square test or Fisher exact test
- Normal continuous variables will be compared using the Student's t test
- Non normal continuous variables will be compared using the Mann-Whitney rank-sum test (unpaired data) or the Wilcoxon test (paired data).
- The actuarial probability of survival will be calculated by the Kaplan-Meier method and compared using the log-rank test.
- A Cox regression analysis will be performed to identify independent prognostic factors for survival.
- Univariate and multivariate analysis will be used whenever applicable.
- Adverse effects - Chest pain, pain at the site, Breathlessness, infection, pneumothorax, infection, bleeding
- Stopping rule -
- Liver Transplant
- Appearance of SBP, PICD, HE.
- Mortality
- End of follow-up
- Conditions
- Hepatic Hydrothorax
- Being tested
- Large Volume Thoracocentesis, Pigtail Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large Volume ThoracocentesisProcedure or surgery
Large Volume Thoracocentesis
Pigtail CatheterProcedure or surgery
Pigtail Catheter
| Study group | Role | What they receive |
|---|---|---|
| Large Volume Thoracocentesis | Experimental | Group 1 - on-demand therapeutic thoracocentensis Receives: Procedure: Large Volume Thoracocentesis |
| Pigtail Catheter | Active comparator | Group 2 - small volume frequent thoracocentesis using PCD Receives: Procedure: Pigtail Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Repeated Thoracocentesis
Measured: Day 30
Frequency of Repeated Thoracocentesis
Measured: Day 90
Secondary outcomes (44)
Incidence of refilling hydrothorax within
Measured: 72 hours
Frequency of Repeated Thoracocentesis.
Measured: Day 30 and Day 90
Rate of Complete Response, Partial Response, No response.
Measured: Day 7, Day 30, Day 90
Number of times Thoracocentesis is required between both groups at Day 30
Measured: Day 30
Number of times Thoracocentesis is required between both groups at Day 90
Measured: Day 90
Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 7
Measured: Day 7
Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 30
Measured: Day 30
Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 90
Measured: Day 90
Change in Renal parameters - Serum Creatinine at Day 7
Measured: Day 7
Change in Renal parameters - Serum Creatinine at Day 30
Measured: Day 30
Change in Renal parameters - Serum Creatinine at Day 90
Measured: Day 90
Hepatic encephalopathy: Grading as per West Haven Classification.
West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.
Measured: Day 7
Hepatic encephalopathy: Grading as per West Haven Classification.
West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.
Measured: Day 30
Hepatic encephalopathy: Grading as per West Haven Classification.
West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.
Measured: Day 90
Proportion of participants developing Na < 120 meg/l Day 7
Measured: Day 7
Proportion of participants developing Na < 120 meg/l Day 30
Measured: Day 30
Proportion of participants developing Na < 120 meg/l Day 90
Measured: Day 90
Dose of Diuretic in each arm Day 7
Measured: Day 7
Dose of Diuretic in each arm Day 30
Measured: Day 30
Dose of Diuretic in each arm Day 90
Measured: Day 90
Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 7
Measured: Day 7
Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 30
Measured: Day 30
Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 90
Measured: Day 90
Proportion of patients developing Spontaneous Bacterial Empyema Day 7
Measured: Day 7
Proportion of patients developing Spontaneous Bacterial Empyema Day 30
Measured: Day 30
Proportion of patients developing Spontaneous Bacterial Empyema Day 90
Measured: Day 90
No. of days pateint surviving without Liver transplant and TIPS at Day 7
Measured: Day 7
No. of days pateint surviving without Liver transplant and TIPS at Day 30
Measured: Day 30
No. of days pateint surviving without Liver transplant and TIPS at Day 90
Measured: Day 90
Incidence of Post procedure complications in between both groups at Day 7
Measured: Day 7
Incidence of Post procedure complications in between both groups at Day 30
Measured: Day 30
Incidence of Post procedure complications in between both groups at Day 90
Measured: Day 90
Changes in MELD between the groups
Measured: Day 7
Changes in MELD between the groups
Measured: Day 30
Changes in MELD between the groups
Measured: Day 90
Changes in CTP between the groups
Measured: Day 7
Changes in CTP between the groups
Measured: Day 30
Changes in CTP between the groups
Measured: Day 90
Number of Episodes of Hospitalization between both groups at Day 7
Measured: Day 7
Number of Episodes of Hospitalization between both groups at Day 30
Measured: Day 30
Number of Episodes of Hospitalization between both groups at Day 90
Measured: Day 90
Cumulative dose of albumin at D7 in two groups
Measured: Day 7
Cumulative dose of albumin at D30 in two groups
Measured: Day 30
Cumulative dose of albumin at D90 in two groups
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start15 Aug 2023 (estimated)
- Primary completion27 Feb 2024 (estimated)
- Study completion27 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic HydrothoraxStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007820
- Sponsor's protocol ID
- ILBS-Cirrhosis-60
- Status last verified
- Aug 2023
- First submitted
- 5 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy & Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06007820
- Acronym / sponsor ID
- ILBS-Cirrhosis-60
- Conditions
- Hepatic Hydrothorax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 27 Feb 2024 (estimated)
- Study completion
- 27 Feb 2024 (estimated)
- First posted
- 23 Aug 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.
In cirrhotic patients with recurrent hepatic hydrothorax liver transplantation is a definitive treatment. But a significant number of individual are ineligible for liver transplantation. In these patients to ameliorate the symptoms various treatment modalities such as TIPS, serial thoracocentesis, pigtail catheter drainage and pleurodesis are used. We are doing this study to assess the safety and efficacy of serial thoracocentesis verus pigtail catheter drainage.
Detailed description
- Study population - Cirrhotic patients with recurrent hepatic hydrothorax
- Study design - A prospective, randomized, single center open label study
- Block Randomization, block size - 10
- Sample size - Assuming in single time thoracocentesis group 5+/-3.67 thoracocentesis is required, investigator expect a 50 % reduction in pigtail drainage group. Apha error- 5, power -90, 15% dropout 35 patients in each arm
- Intervention - Group 1 - on-demand therapeutic thoracocentensis, Group 2 - small volume frequent thoracocentesis using PCD.
- Monitoring and assessment
- At enrollment: (A) Complete history and examination
- Etiology of cirrhosis
- Severity of ascites, Jaundice
- Prior Hepatic encephalopathy, bleed, Jaundice
- Prior Spontaneous bacterial peritonitis, large volume paracentesis frequency
- Pattern and number of prior decompensation
- Prior Acute on Chronic Liver Failure and Acute Kidney episodes
- Use of non selective beta blockers, norfloxaxin, rifaximin and albumin
- History of Endoscopic Variceal ligation or other endotherapy
- History of Hypertension, Diabetes
- Fever , signs of sepsis (SIRS)
- Examination- Sarcopenia, fraility, icterus, pedal edema
At follow-up (at daily till Day - 7, thereafter at Day - 30 and Day 90) Complete history and examination
- Complications - SBP, SBE, ACLF and Jaundice, HE/ AKI episodes
- HTN, Diabetes control
- Fever , signs of sepsis (SIRS)
- Examination- Sarcopenia, fraility, icterus, pedal edema, ascites, HE Clinical Evaluation
- Etiology of chronic liver disease (Baseline) 2. Severity of liver disease (Baseline, Day - 7, Day - 30, Day - 90 ) 3. MELD score, MELD-Na score, CTP score (Baseline, Day - 7, Day - 30, Day - 90 ) 4. Complications (Baseline, Day - 7, Day - 30, Day - 90 ) 5. Overt HE, PHT related Bleed, clinical jaundice, ascites, hyponatremia, AKI, SBP, Infection (specify site and severity), Frequency of Large Volume Paracentesis, On Demand Thoracocentesis
- Labs and follow up Baseline (at admission) -
- Blood : KFT, LFT, CBC, INR, AFP, PCT, S.PRA, Pro-BNP, Urinary Na
- Imaging : USG abdomen, X-ray chest, 2D ECHO
- Pleural fluid/ ascitic fluid - TLC, DLC, Protein, Sugar, SPAG, SAAG, ADA, c/s
- Hemodynamics : Intrapleural pressures at first TT
- Baseline (at randomization, Day -3 and Day - 7 in PCD-TT) -
- Blood : KFT, INR; S.PRA, Pro-BNP, Urinary Na (at Day 7)
- Imaging : X-ray chest
- Pleural fluid/ ascitic fluid - TLC, DLC, SPAG, c/s if indicated
- Day - 60, Day - 90 (end of follow-up)
- Blood : KFT, LFT, CBC, INR, AFP
- Imaging : USG abdomen, X-ray chest, 2D ECHO
- STATISTICAL ANALYSIS -
- Data will be reported as mean + SD.
- Categorical variables will be compared using the chi-square test or Fisher exact test
- Normal continuous variables will be compared using the Student's t test
- Non normal continuous variables will be compared using the Mann-Whitney rank-sum test (unpaired data) or the Wilcoxon test (paired data).
- The actuarial probability of survival will be calculated by the Kaplan-Meier method and compared using the log-rank test.
- A Cox regression analysis will be performed to identify independent prognostic factors for survival.
- Univariate and multivariate analysis will be used whenever applicable.
- Adverse effects - Chest pain, pain at the site, Breathlessness, infection, pneumothorax, infection, bleeding
- Stopping rule -
- Liver Transplant
- Appearance of SBP, PICD, HE.
- Mortality
- End of follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Large Volume Thoracocentesis | Experimental | Procedure: Large Volume ThoracocentesisGroup 1 - on-demand therapeutic thoracocentensis |
| Pigtail Catheter | Active comparator | Procedure: Pigtail CatheterGroup 2 - small volume frequent thoracocentesis using PCD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-75 years
- CLD with refilling symptomatic hepatic hydrothorax
Key exclusion criteria (16 listed)
- CTP >12, MELD>25
- Tubercular PE, Ischemic cardiac disease
- If opting for TIPS/ LT
- Severe HPS
- Prior or current SBE/ SBP, septic shock
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 |
|---|---|---|
| Large Volume ThoracocentesisLarge Volume Thoracocentesis | Procedure or surgery | Large Volume Thoracocentesis |
| Pigtail CatheterPigtail Catheter | Procedure or surgery | Pigtail Catheter |
Primary outcome
Frequency of Repeated Thoracocentesis
Time frame: Day 30
Frequency of Repeated Thoracocentesis
Time frame: Day 90
44 secondary outcomes
Incidence of refilling hydrothorax within
Time frame: 72 hours
Frequency of Repeated Thoracocentesis.
Time frame: Day 30 and Day 90
Rate of Complete Response, Partial Response, No response.
Time frame: Day 7, Day 30, Day 90
Number of times Thoracocentesis is required between both groups at Day 30
Time frame: Day 30
Number of times Thoracocentesis is required between both groups at Day 90
Time frame: Day 90
Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 7
Time frame: Day 7
Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 30
Time frame: Day 30
Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 90
Time frame: Day 90
Change in Renal parameters - Serum Creatinine at Day 7
Time frame: Day 7
Change in Renal parameters - Serum Creatinine at Day 30
Time frame: Day 30
Change in Renal parameters - Serum Creatinine at Day 90
Time frame: Day 90
Hepatic encephalopathy: Grading as per West Haven Classification.
Time frame: Day 7
Hepatic encephalopathy: Grading as per West Haven Classification.
Time frame: Day 30
Hepatic encephalopathy: Grading as per West Haven Classification.
Time frame: Day 90
Proportion of participants developing Na < 120 meg/l Day 7
Time frame: Day 7
Proportion of participants developing Na < 120 meg/l Day 30
Time frame: Day 30
Proportion of participants developing Na < 120 meg/l Day 90
Time frame: Day 90
Dose of Diuretic in each arm Day 7
Time frame: Day 7
Dose of Diuretic in each arm Day 30
Time frame: Day 30
Dose of Diuretic in each arm Day 90
Time frame: Day 90
Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 7
Time frame: Day 7
Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 30
Time frame: Day 30
Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 90
Time frame: Day 90
Proportion of patients developing Spontaneous Bacterial Empyema Day 7
Time frame: Day 7
Proportion of patients developing Spontaneous Bacterial Empyema Day 30
Time frame: Day 30
Proportion of patients developing Spontaneous Bacterial Empyema Day 90
Time frame: Day 90
No. of days pateint surviving without Liver transplant and TIPS at Day 7
Time frame: Day 7
No. of days pateint surviving without Liver transplant and TIPS at Day 30
Time frame: Day 30
No. of days pateint surviving without Liver transplant and TIPS at Day 90
Time frame: Day 90
Incidence of Post procedure complications in between both groups at Day 7
Time frame: Day 7
Incidence of Post procedure complications in between both groups at Day 30
Time frame: Day 30
Incidence of Post procedure complications in between both groups at Day 90
Time frame: Day 90
Changes in MELD between the groups
Time frame: Day 7
Changes in MELD between the groups
Time frame: Day 30
Changes in MELD between the groups
Time frame: Day 90
Changes in CTP between the groups
Time frame: Day 7
Changes in CTP between the groups
Time frame: Day 30
Changes in CTP between the groups
Time frame: Day 90
Number of Episodes of Hospitalization between both groups at Day 7
Time frame: Day 7
Number of Episodes of Hospitalization between both groups at Day 30
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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The BD Liverty™ TIPS Stent Graft Study
Portal Hypertension, TIPS
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large Volume Thoracocentesis and Pigtail Catheter in people with Hepatic Hydrothorax, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 2 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Jaifrin Daniel, MD (01146300000, jdaniel.m07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Repeated Thoracocentesis (time frame: Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.