Pneumothorax Spontaneous PrimaryNCT03293199
Comparing Efficacy of Chest Tube Drainage and Needle Aspiration in Pneumothorax Treatment
A study testing Chest tube drainage and Repetitive needle aspiration in people with Pneumothorax Spontaneous Primary and Pneumothorax, Recurrent, run by Tabriz University of Medical Sciences at 1 site in Iran.
Trial summary
Spontaneous pneumothorax is a common condition which is defined as air presence inside of pleural space. Despite, several studies that have been carried on management patients suffering spontaneous pneumothorax, the first step approach on patients is still the topic of debate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax Spontaneous Primary, Pneumothorax, Recurrent, Pneumothorax Spontaneous Tension
- What is being tested?
- Chest tube drainage and Repetitive needle aspiration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- 12 Aug 2017to 12 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged more than 18 years old
- Symptomatic primary spontaneous pneumothorax or intervention-needed spontaneous pneumothorax (pneumothorax more than 20% in volume due to Light criteria)
Who cannot join
- Tension pneumothorax
- bilateral severe respiratory failure
- demand for mechanical ventilation
- bilateral pneumothorax
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Imam Reza hospital
Tabriz, East Azerbaijan Province
Seyed Ziaeddin Rasihashemi, Professor, +989144126652, zia.hashemi@yahoo.com
Ali Ramouz
About this study
Official title: Randomized Controlled Trial on Comparison of Chest Tube Drainage and Needle Aspiration in Treatment of Spontaneous Pneumothorax
Spontaneous pneumothorax is a common condition which is defined as air presence inside of pleural space. Despite, several studies that have been carried on management patients suffering spontaneous pneumothorax, the first step approach on patients is still the topic of debate. Since chest tube drainage and needle aspiration are widely used first step techniques in spontaneous pneumothorax, current study compares the efficacy of abovementioned techniques, as well as long-term outcomes. In current multi-center single-blinded RCT, all patients admitted with spontaneous pneumothorax will be enrolled study and written consent form provided by patients, simultaneously. Patients randomly assigned to study groups including (A) chest tube drainage and (B) needle aspiration. Subsequently, all patients will undergo one-year follow-up and will be evaluated in terms of treatment success rate and pneumothorax recurrence. Hypothesis of present trial are as follows: a) repetitive needle aspiration may lead to higher treatment success rate in patients with primary spontaneous pneumothorax, in comparison to chest tube drainage, b) needle aspiration may result in reduction of hospital admission duration in patients with primary spontaneous pneumothorax compared to chest tube drainage, c) the rate of spontaneous pneumothorax recurrence during one-year follow up might be lower in patients who undergo needle aspiration instead of chest tube drainage.
Read the detailed description
The chest tube drainage and needle aspiration are widely used first step techniques in spontaneous pneumothorax, thus present randomized controlled trial (RCT) aims to compare the efficacy of abovementioned techniques, as well as long-term outcomes. The study protocol has been confirmed by the ethics committee of AJA University. In current multi-center single-blinded RCT, all patients admitted with primary spontaneous pneumothorax will be enrolled study and written consent form provided by patients, simultaneously. With due attention to the success rate of 18% provided in a previous study comparing primary spontaneous pneumothorax treatment procedures and the study power of 80% and the confidence coefficient of 0.05, study population calculated to include 64 patient, which increased to 70 patients with taking 10% of falling risk into consideration. Using Randlist software, patients will be randomly assigned to study groups including (A) chest tube drainage and (B) needle aspiration. Subsequently, all patients will undergo one-year follow-up and will be evaluated in terms of treatment success rate and pneumothorax recurrence.
In chest tube drainage group, while the patient is positioned in the supine position and subsequent to local anesthesia administration via lidocaine 2%, F16 or F20 (based on patients physical status) sterile plastic tube will be implemented at the level 4th or 5th intercostal space through the midaxillary line. However, in needle aspiration group, patients will be positioned semi-supine. Subsequently, G16 intravenous angiocath will be inserted through the midclavicular line at the level 2nd or 3rd intercostal space. The catheter needle will be removed and catheter will be fixed using sterile sticks. A three-way valve will be connected to the external end of the catheter and a 50 ml syringe will be connected to the valve. The air suction will be performed using 50 ml syringe till end of the air suction or up to 3.5 liters of air suctioning.
Hypothesis of present trial are as follows: a) repetitive needle aspiration may lead to higher treatment success rate in patients with primary spontaneous pneumothorax, in comparison to chest tube drainage, b) needle aspiration may result in reduction of hospital admission duration in patients with primary spontaneous pneumothorax compared to chest tube drainage, c) the rate of spontaneous pneumothorax recurrence during one-year follow-up might be lower in patients who undergo needle aspiration instead of chest tube drainage.
- Conditions
- Pneumothorax Spontaneous Primary, Pneumothorax, Recurrent, Pneumothorax Spontaneous Tension, Pneumothorax, Spontaneous
- Being tested
- Chest tube drainage, Repetitive needle aspiration
- Medical subject headings
- Pneumothorax, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest tube drainageProcedure or surgery
In this group, in the supine position and subsequent to prepping and draping and local anesthesia administration via lidocaine 2%, F16 or F20 (based on patients physical status) sterile plastic tube will be implemented at the level 4th or 5th intercostal space through the midaxillary line. Subsequently, the external end of the tube will be connected to water sealing bottle and water bubbles coming out will be considered as proper chest tube insertion.
Repetitive needle aspirationProcedure or surgery
In this group, prior to needle aspiration, patients will take the semi-supine position. Subsequent to local anesthesia via lidocaine 2%, as well as prepping and draping, G16 intravenous angiocath will be inserted through midclavicular line at the level 2nd or 3rd intercostal space. Air bubble inside the lidocaine syringe will be considered as needled entrance to pleural cavity, thus 5-10 cm of the angiocath will be import to inside of the cavity. The catheter needle will be removed and catheter will be fixed using sterile sticks. A three-way valve will be connected to external end of the catheter and a 50 ml syringe will be connected to the valve. The air suction will be performed using 50 ml syringe till end of the air suction or up to 3.5 liters of air suctioning.
| Study group | Role | What they receive |
|---|---|---|
| Chest tube drainage | Active comparator | This group will undergo chest tube drainage as an intervention for spontaneous pneumothorax treatment. Receives: Procedure: Chest tube drainage |
| Needle aspiration | Active comparator | This group will undergo repetitive needle aspiration as an intervention for spontaneous pneumothorax treatment. Receives: Procedure: Repetitive needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumothorax recurrence during one-year
Will be defined as the rate of pneumothorax recurrence until postoperative one-year.
Measured: One year postoperative
Secondary outcomes (5)
Successful treatment rate
Is defined as completely resolved pneumothorax during admission.
Measured: Postoperative day 1 and postoperative day 7
Length of hospital admission
will be calculated from the time of the operation to time of discharge.
Measured: Through hospital admission, an average of 10 days
Operation time
Will be calculated from the time of skin incision to completing the procedure including complete chest tube insertion in chest tube group or complete air suction or up to 3.5 liters of air suction in needle aspiration group.
Measured: During procedure
Procedure induced complications
Includes all complications occurred during or after procedure during hospital stay.
Measured: Postoperative day 1, Postoperative day 3, Postoperative day 7, Postoperative month 1,
Pneumothorax size
Will be calculated by Light's formula using chest radiography
Measured: Before procedure, 1 hour after procedure, 48 hours after procedure, one-week after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start12 Aug 2017
- Primary completion12 Jul 2018 (estimated)
- Study completion12 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pneumothorax Spontaneous PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly and equally assigned to study groups, as follows: group (a) will undergo chest tube drainage implementation and group (b) will undergo repetitive needle aspiration till pnuemothorax resolution.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabriz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- AJA University of Medical Sciences
- Responsible party
- Principal investigator, Ali Ramouz, Tabriz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293199
- Sponsor's protocol ID
- IR.AJAUMS.REC.1396.24
- Status last verified
- Sep 2017
- First submitted
- 18 Sep 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tschopp JM, Marquette CH. Spontaneous pneumothorax: stop chest tube as first-line therapy. Eur Respir J. 2017 Apr 12;49(4):1700306. doi: 10.1183/13993003.00306-2017. Print 2017 Apr. No abstract available.
PubMed 28404655Hu X, Cowl CT, Baqir M, Ryu JH. Air travel and pneumothorax. Chest. 2014 Apr;145(4):688-694. doi: 10.1378/chest.13-2363.
PubMed 24687705Cran IR, Rumball CA. Survey of spontaneous pneumothoraces in the Royal Air Force. Thorax. 1967 Sep;22(5):462-5. doi: 10.1136/thx.22.5.462.
PubMed 6050294Harvey J, Prescott RJ. Simple aspiration versus intercostal tube drainage for spontaneous pneumothorax in patients with normal lungs. British Thoracic Society Research Committee. BMJ. 1994 Nov 19;309(6965):1338-9. doi: 10.1136/bmj.309.6965.1338. No abstract available.
PubMed 7755720Dzeljilji A, Rokicki W, Rokicki M, Karus K. New aspects in the diagnosis and treatment of primary spontaneous pneumothorax. Kardiochir Torakochirurgia Pol. 2017 Mar;14(1):27-31. doi: 10.5114/kitp.2017.66926. Epub 2017 Mar 31.
PubMed 28515745MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. No abstract available.
PubMed 20696690Thelle A, Gjerdevik M, SueChu M, Hagen OM, Bakke P. Randomised comparison of needle aspiration and chest tube drainage in spontaneous pneumothorax. Eur Respir J. 2017 Apr 12;49(4):1601296. doi: 10.1183/13993003.01296-2016. Print 2017 Apr.
PubMed 28404647Tschopp JM, Bintcliffe O, Astoul P, Canalis E, Driesen P, Janssen J, Krasnik M, Maskell N, Van Schil P, Tonia T, Waller DA, Marquette CH, Cardillo G. ERS task force statement: diagnosis and treatment of primary spontaneous pneumothorax. Eur Respir J. 2015 Aug;46(2):321-35. doi: 10.1183/09031936.00219214. Epub 2015 Jun 25.
PubMed 26113675Wakai A, O'Sullivan RG, McCabe G. Simple aspiration versus intercostal tube drainage for primary spontaneous pneumothorax in adults. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD004479. doi: 10.1002/14651858.CD004479.pub2.
PubMed 17253510
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Comparison of Chest Tube Drainage and Needle Aspiration in Treatment of Spontaneous Pneumothorax
- ClinicalTrials.gov ID
- NCT03293199
- Acronym / sponsor ID
- IR.AJAUMS.REC.1396.24
- Conditions
- Pneumothorax Spontaneous Primary, Pneumothorax, Recurrent, Pneumothorax Spontaneous Tension, Pneumothorax, Spontaneous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tabriz University of Medical SciencesUniversity, hospital or other
- Collaborators
- AJA University of Medical Sciences
- Study start
- 12 Aug 2017 (actual)
- Primary completion
- 12 Jul 2018 (estimated)
- Study completion
- 12 Oct 2018 (estimated)
- First posted
- 26 Sep 2017 (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.
Spontaneous pneumothorax is a common condition which is defined as air presence inside of pleural space. Despite, several studies that have been carried on management patients suffering spontaneous pneumothorax, the first step approach on patients is still the topic of debate. Since chest tube drainage and needle aspiration are widely used first step techniques in spontaneous pneumothorax, current study compares the efficacy of abovementioned techniques, as well as long-term outcomes. In current multi-center single-blinded RCT, all patients admitted with spontaneous pneumothorax will be enrolled study and written consent form provided by patients, simultaneously. Patients randomly assigned to study groups including (A) chest tube drainage and (B) needle aspiration. Subsequently, all patients will undergo one-year follow-up and will be evaluated in terms of treatment success rate and pneumothorax recurrence. Hypothesis of present trial are as follows: a) repetitive needle aspiration may lead to higher treatment success rate in patients with primary spontaneous pneumothorax, in comparison to chest tube drainage, b) needle aspiration may result in reduction of hospital admission duration in patients with primary spontaneous pneumothorax compared to chest tube drainage, c) the rate of spontaneous pneumothorax recurrence during one-year follow up might be lower in patients who undergo needle aspiration instead of chest tube drainage.
Detailed description
The chest tube drainage and needle aspiration are widely used first step techniques in spontaneous pneumothorax, thus present randomized controlled trial (RCT) aims to compare the efficacy of abovementioned techniques, as well as long-term outcomes. The study protocol has been confirmed by the ethics committee of AJA University. In current multi-center single-blinded RCT, all patients admitted with primary spontaneous pneumothorax will be enrolled study and written consent form provided by patients, simultaneously. With due attention to the success rate of 18% provided in a previous study comparing primary spontaneous pneumothorax treatment procedures and the study power of 80% and the confidence coefficient of 0.05, study population calculated to include 64 patient, which increased to 70 patients with taking 10% of falling risk into consideration. Using Randlist software, patients will be randomly assigned to study groups including (A) chest tube drainage and (B) needle aspiration. Subsequently, all patients will undergo one-year follow-up and will be evaluated in terms of treatment success rate and pneumothorax recurrence.
In chest tube drainage group, while the patient is positioned in the supine position and subsequent to local anesthesia administration via lidocaine 2%, F16 or F20 (based on patients physical status) sterile plastic tube will be implemented at the level 4th or 5th intercostal space through the midaxillary line. However, in needle aspiration group, patients will be positioned semi-supine. Subsequently, G16 intravenous angiocath will be inserted through the midclavicular line at the level 2nd or 3rd intercostal space. The catheter needle will be removed and catheter will be fixed using sterile sticks. A three-way valve will be connected to the external end of the catheter and a 50 ml syringe will be connected to the valve. The air suction will be performed using 50 ml syringe till end of the air suction or up to 3.5 liters of air suctioning.
Hypothesis of present trial are as follows: a) repetitive needle aspiration may lead to higher treatment success rate in patients with primary spontaneous pneumothorax, in comparison to chest tube drainage, b) needle aspiration may result in reduction of hospital admission duration in patients with primary spontaneous pneumothorax compared to chest tube drainage, c) the rate of spontaneous pneumothorax recurrence during one-year follow-up might be lower in patients who undergo needle aspiration instead of chest tube drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly and equally assigned to study groups, as follows: group (a) will undergo chest tube drainage implementation and group (b) will undergo repetitive needle aspiration till pnuemothorax resolution.
| Arm | Type | Receives |
|---|---|---|
| Chest tube drainage | Active comparator | Procedure: Chest tube drainageThis group will undergo chest tube drainage as an intervention for spontaneous pneumothorax treatment. |
| Needle aspiration | Active comparator | Procedure: Repetitive needle aspirationThis group will undergo repetitive needle aspiration as an intervention for spontaneous pneumothorax treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged more than 18 years old
- Symptomatic primary spontaneous pneumothorax or intervention-needed spontaneous pneumothorax (pneumothorax more than 20% in volume due to Light criteria)
Key exclusion criteria (4 listed)
- Tension pneumothorax
- bilateral severe respiratory failure
- demand for mechanical ventilation
- bilateral pneumothorax
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 |
|---|---|---|
| Chest tube drainageIn this group, in the supine position and subsequent to prepping and draping and local anesthesia administration via lidocaine 2%, F16 or F20 (based on patients physical status) sterile plastic tube will be implemented at the level 4th or 5th intercostal space through the midaxillary line. Subsequently, the external end of the tube will be connected to water sealing bottle and water bubbles coming out will be considered as proper chest tube insertion. | Procedure or surgery | Chest tube drainage |
| Repetitive needle aspirationIn this group, prior to needle aspiration, patients will take the semi-supine position. Subsequent to local anesthesia via lidocaine 2%, as well as prepping and draping, G16 intravenous angiocath will be inserted through midclavicular line at the level 2nd or 3rd intercostal space. Air bubble inside the lidocaine syringe will be considered as needled entrance to pleural cavity, thus 5-10 cm of the angiocath will be import to inside of the cavity. The catheter needle will be removed and catheter will be fixed using sterile sticks. A three-way valve will be connected to external end of the catheter and a 50 ml syringe will be connected to the valve. The air suction will be performed using 50 ml syringe till end of the air suction or up to 3.5 liters of air suctioning. | Procedure or surgery | Needle aspiration |
Primary outcome
Pneumothorax recurrence during one-year
Time frame: One year postoperative
Will be defined as the rate of pneumothorax recurrence until postoperative one-year.
5 secondary outcomes
Successful treatment rate
Time frame: Postoperative day 1 and postoperative day 7
Length of hospital admission
Time frame: Through hospital admission, an average of 10 days
Operation time
Time frame: During procedure
Procedure induced complications
Time frame: Postoperative day 1, Postoperative day 3, Postoperative day 7, Postoperative month 1,
Pneumothorax size
Time frame: Before procedure, 1 hour after procedure, 48 hours after procedure, one-week after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Background: PubMed 28404655Tschopp JM, Marquette CH. Spontaneous pneumothorax: stop chest tube as first-line therapy. Eur Respir J. 2017 Apr 12;49(4):1700306. doi: 10.1183/13993003.00306-2017. Print 2017 Apr. No abstract available.
- Background: PubMed 24687705Hu X, Cowl CT, Baqir M, Ryu JH. Air travel and pneumothorax. Chest. 2014 Apr;145(4):688-694. doi: 10.1378/chest.13-2363.
- Background: PubMed 6050294Cran IR, Rumball CA. Survey of spontaneous pneumothoraces in the Royal Air Force. Thorax. 1967 Sep;22(5):462-5. doi: 10.1136/thx.22.5.462.
- Background: PubMed 7755720Harvey J, Prescott RJ. Simple aspiration versus intercostal tube drainage for spontaneous pneumothorax in patients with normal lungs. British Thoracic Society Research Committee. BMJ. 1994 Nov 19;309(6965):1338-9. doi: 10.1136/bmj.309.6965.1338. No abstract available.
- Background: PubMed 28515745Dzeljilji A, Rokicki W, Rokicki M, Karus K. New aspects in the diagnosis and treatment of primary spontaneous pneumothorax. Kardiochir Torakochirurgia Pol. 2017 Mar;14(1):27-31. doi: 10.5114/kitp.2017.66926. Epub 2017 Mar 31.
- Background: PubMed 20696690MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. No abstract available.
- Background: PubMed 28404647Thelle A, Gjerdevik M, SueChu M, Hagen OM, Bakke P. Randomised comparison of needle aspiration and chest tube drainage in spontaneous pneumothorax. Eur Respir J. 2017 Apr 12;49(4):1601296. doi: 10.1183/13993003.01296-2016. Print 2017 Apr.
- Background: PubMed 26113675Tschopp JM, Bintcliffe O, Astoul P, Canalis E, Driesen P, Janssen J, Krasnik M, Maskell N, Van Schil P, Tonia T, Waller DA, Marquette CH, Cardillo G. ERS task force statement: diagnosis and treatment of primary spontaneous pneumothorax. Eur Respir J. 2015 Aug;46(2):321-35. doi: 10.1183/09031936.00219214. Epub 2015 Jun 25.
- Background: PubMed 17253510Wakai A, O'Sullivan RG, McCabe G. Simple aspiration versus intercostal tube drainage for primary spontaneous pneumothorax in adults. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD004479. doi: 10.1002/14651858.CD004479.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest tube drainage and Repetitive needle aspiration in people with Pneumothorax Spontaneous Primary and Pneumothorax, Recurrent, run by Tabriz University of Medical Sciences at 1 site in Iran.
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 4 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 26 Sep 2017. 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 Iran. 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 Ali Ramouz (+989399418336, ramouza@tbzmed.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumothorax recurrence during one-year (time frame: One year postoperative). 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 NCT03293199, which also lists 9 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 26 Sep 2017.