Mediastinal or Intra-abdominal Lymphadenopathy,NCT01213290
A Randomized Controlled Trial Of Endoscopic Ultrasound-Guided Fine-Needle Aspiration With And Without A Stylet
A study testing EUS - FNA with stylet and Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in people with Mediastinal or Intra-abdominal Lymphadenopathy, and Pancreatic Masses,, run by American Society for Gastrointestinal Endoscopy at 2 sites in United States.
Trial summary
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become an important tool in the diagnostic evaluation of gastrointestinal tract lesions and other organ sites such as mediastinal and intra-abdominal lymphadenopathy, pancreatic masses, liver masses, left adrenal masses and gastrointestinal submucosal… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mediastinal or Intra-abdominal Lymphadenopathy,, Pancreatic Masses,, Left Adrenal Masses,
- What is being tested?
- EUS - FNA with stylet and Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Mar 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Presence of mediastinal or intra-abdominal lymphadenopathy, solid pancreatic mass, left adrenal mass, gastrointestinal submucosal lesions or liver mass confirmed by at least a single investigational modality - CT scan, magnetic resonance imaging, endoscopy.
- Capable of providing informed consent
Who cannot join
- Severe coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000)
- Lesion unable to be sampled due to the presence of intervening blood vessels
- Results of EUS-FNA would not impact patient management
- Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Veterans Affairs Medical Center
Kansas City, Missouri, 64128
About this study
Official title: A Randomized Controlled Trial Of Endoscopic Ultrasound-Guided Fine-Needle Aspiration With And Without A Stylet : A Pilot Study
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become an important tool in the diagnostic evaluation of gastrointestinal tract lesions and other organ sites such as mediastinal and intra-abdominal lymphadenopathy, pancreatic masses, liver masses, left adrenal masses and gastrointestinal submucosal lesions. It provides crucial information that can have tremendous impact on patient management. FNA is typically performed using a 22- or 25-gauge needle with a stylet under EUS guidance. The lesion is punctured with a stylet in place in the needle. After withdrawal of the stylet, the needle is moved to and fro within the lesion and this process is repeated for each needle pass. It is currently believed that the use of a stylet for EUS-FNA improves the quality of specimens by preventing the tip of the needle being clogged up with tissue and hence enhances the diagnostic yield of specimens obtained. However, there are no data demonstrating clearly that the use of a stylet improves the yield of EUS-FNA. The reason why this question is important is because the use of a stylet during EUS-FNA is cumbersome, time and energy consuming and increases the costs of EUS-FNA needle systems.
In this prospective randomized controlled trial, patients referred for EUS-FNA of mediastinal and intra-abdominal lymphadenopathy, pancreatic mass, liver mass, left adrenal mass and gastrointestinal submucosal tumors will be included. FNA will be performed with a 22-gauge needle under EUS guidance using suction with a 10 mL syringe by two experienced endosonographers. The technique to be used for fine needle sampling i.e. with a stylet in place or without a stylet for each FNA pass will be assigned by using a preprinted randomization scheme obtained from a sealed envelope and clearly documented. Each lesion will be sampled for a minimum of four needle passes. The pathologists providing the final interpretation will be blinded to technique of EUS-FNA (with or without stylet). The degree of cellularity, contamination, amount of blood, adequacy of sample, frequency with which a positive diagnosis is made will be compared between the two groups (EUS-FNA with stylet vs. EUS-FNA without stylet). The sensitivity, specificity, accuracy, positive predictive value and negative predictive value of each technique when compared to the final diagnosis will be calculated. Inter-observer agreement among cytopathologists will be assessed for specimens obtained from EUS-FNA with stylet and for those obtained from EUS-FNA without a stylet.
Read the detailed description
Various techniques have been described to optimize accuracy, efficiency, and quality of EUS-FNA specimens. FNA is typically performed using a 22- or 25-gauge needle with a stylet under EUS guidance. The lesion is punctured with a stylet in place or slightly withdrawing the needle. After puncture, the stylet is pushed out of the needle tip and then the needle is moved to and fro within the lesion and this process is repeated for each needle pass. It is currently believed that the use of a stylet for EUS-FNA helps prevent clogging of the needle by gut wall tissue, which could limit the ability to aspirate cells from the target lesion. This may improve the quality of specimens and hence enhance the diagnostic yield of specimens obtained. This is a logical assumption, but there are no data demonstrating clearly that the use of a stylet increases the yield of EUS-FNA. At the present time, it is recommended that the stylet is re-inserted back into the needle prior to each FNA pass. The use of a stylet during EUS-FNA is cumbersome, time and energy consuming and increases the costs of EUS-FNA needle systems. In some circumstances, the stylet may actually make EUS-FNA very difficult as it may be impossible to advance or remove the stylet once the target has been punctured. This tends to occur when the echoendoscope or the needle is bent and a large (19 gauge) needle is being used. In addition, the data comparing the effectiveness of EUS-FNA with stylet to FNA without stylet is limited. Paquin et al compared the adequacy, the bloodiness, and the yield of FNA samples obtained with a stylet to FNA without a stylet. In this study, the use of stylet for EUS-FNA was associated with a reduced specimen adequacy and more bloody passes. 13 Thus the use of a stylet for EUS-FNA is questionable and needs further investigation. If the diagnostic yield, adequacy and quality of specimens obtained by EUS-FNA without a stylet is found to be equivalent to that with a stylet, this could potentially make a strong case for not using a stylet and thus making the procedure easier, more time- and cost-efficient. The hypothesis and specific aims of this prospective randomized controlled trial are as follows:
First hypothesis: There is no difference in the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet Specific Aim #1: To compare the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet
Second hypothesis: There is no difference in the diagnostic yield of malignancy in specimens obtained by EUS-FNA with a stylet compared with EUS-FNA without a stylet.
Specific Aim #2: To compare the diagnostic yield of malignancy in specimens obtained by EUS-FNA with and without a stylet.
Third hypothesis: An acceptable level of inter-observer agreement exists among cytopathologists in the assessment of specimens obtained from EUS-FNA with stylet and EUS-FNA without a stylet.
Specific Aim #3: To assess the inter-observer agreement among cytopathologists in the evaluation of specimens obtained from EUS-FNA with stylet and specimens obtained from EUS-FNA without a stylet.
- Conditions
- Mediastinal or Intra-abdominal Lymphadenopathy,, Pancreatic Masses,, Left Adrenal Masses,, Gastrointestinal Submucosal Lesions, and, Liver Masses
- Being tested
- EUS - FNA with stylet, Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA)
- Keywords
- Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), Stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS - FNA with styletDevice
Also called FNA Stylet
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) with stylet. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become a useful tool in the diagnostic evaluation of gastrointestinal tract lesions as well as other accessible organ sites and has found a wide use in the management of various gastrointestinal and non-gastrointestinal lesions.
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA)Device
Also called FNA without stylet
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA)without stylet. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become a useful tool in the diagnostic evaluation of gastrointestinal tract lesions as well as other accessible organ sites and has found a wide use in the management of various gastrointestinal and non-gastrointestinal lesions.
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNA with stylet | Active comparator | Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) with stylet. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become a useful tool in the diagnostic evaluation of gastrointestinal tract lesions as well as other accessible organ sites and has found a wide use in the management of various gastrointestinal and non-gastrointestinal lesions. Receives: Device: EUS - FNA with stylet |
| EUS-FNA without stylet | Active comparator | Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) without stylet. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become a useful tool in the diagnostic evaluation of gastrointestinal tract lesions as well as other accessible organ sites and has found a wide use in the management of various gastrointestinal and non-gastrointestinal lesions. Receives: Device: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet
First hypothesis: There is no difference in the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet Specific Aim #1: To compare the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet
Measured: 2 years
Secondary outcomes (1)
To compare the diagnostic yield of malignancy in specimens obtained by EUS-FNA with and without a stylet.
Second hypothesis: There is no difference in the diagnostic yield of malignancy in specimens obtained by EUS-FNA with a stylet compared with EUS-FNA without a stylet.
Specific Aim #2: To compare the diagnostic yield of malignancy in specimens obtained by EUS-FNA with and without a stylet.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mediastinal or Intra-abdominal Lymphadenopathy,Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Society for Gastrointestinal Endoscopy
- Sponsor type
- University, hospital or other
- Collaborators
- Midwest Biomedical Research
- Investigators
- Amit Rastogi, MD, Principal investigator, Kansas City Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213290
- Sponsor's protocol ID
- AR0007
- Status last verified
- Sep 2010
- First submitted
- 30 Sep 2010
- Last updated
- 1 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Rastogi A, Wani S, Gupta N, Singh V, Gaddam S, Reddymasu S, Ulusarac O, Fan F, Romanas M, Dennis KL, Sharma P, Bansal A, Oropeza-Vail M, Olyaee M. A prospective, single-blind, randomized, controlled trial of EUS-guided FNA with and without a stylet. Gastrointest Endosc. 2011 Jul;74(1):58-64. doi: 10.1016/j.gie.2011.02.015. Epub 2011 Apr 23.
PubMed 21514932
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Of Endoscopic Ultrasound-Guided Fine-Needle Aspiration With And Without A Stylet : A Pilot Study
- ClinicalTrials.gov ID
- NCT01213290
- Acronym / sponsor ID
- AR0007
- Conditions
- Mediastinal or Intra-abdominal Lymphadenopathy,, Pancreatic Masses,, Left Adrenal Masses,, Gastrointestinal Submucosal Lesions, and, Liver Masses
- Keywords
- Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), Stylet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- American Society for Gastrointestinal EndoscopyUniversity, hospital or other
- Collaborators
- Midwest Biomedical Research
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (estimated)
- First posted
- 1 Oct 2010 (estimated)
- 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.
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become an important tool in the diagnostic evaluation of gastrointestinal tract lesions and other organ sites such as mediastinal and intra-abdominal lymphadenopathy, pancreatic masses, liver masses, left adrenal masses and gastrointestinal submucosal lesions. It provides crucial information that can have tremendous impact on patient management. FNA is typically performed using a 22- or 25-gauge needle with a stylet under EUS guidance. The lesion is punctured with a stylet in place in the needle. After withdrawal of the stylet, the needle is moved to and fro within the lesion and this process is repeated for each needle pass. It is currently believed that the use of a stylet for EUS-FNA improves the quality of specimens by preventing the tip of the needle being clogged up with tissue and hence enhances the diagnostic yield of specimens obtained. However, there are no data demonstrating clearly that the use of a stylet improves the yield of EUS-FNA. The reason why this question is important is because the use of a stylet during EUS-FNA is cumbersome, time and energy consuming and increases the costs of EUS-FNA needle systems.
In this prospective randomized controlled trial, patients referred for EUS-FNA of mediastinal and intra-abdominal lymphadenopathy, pancreatic mass, liver mass, left adrenal mass and gastrointestinal submucosal tumors will be included. FNA will be performed with a 22-gauge needle under EUS guidance using suction with a 10 mL syringe by two experienced endosonographers. The technique to be used for fine needle sampling i.e. with a stylet in place or without a stylet for each FNA pass will be assigned by using a preprinted randomization scheme obtained from a sealed envelope and clearly documented. Each lesion will be sampled for a minimum of four needle passes. The pathologists providing the final interpretation will be blinded to technique of EUS-FNA (with or without stylet). The degree of cellularity, contamination, amount of blood, adequacy of sample, frequency with which a positive diagnosis is made will be compared between the two groups (EUS-FNA with stylet vs. EUS-FNA without stylet). The sensitivity, specificity, accuracy, positive predictive value and negative predictive value of each technique when compared to the final diagnosis will be calculated. Inter-observer agreement among cytopathologists will be assessed for specimens obtained from EUS-FNA with stylet and for those obtained from EUS-FNA without a stylet.
Detailed description
Various techniques have been described to optimize accuracy, efficiency, and quality of EUS-FNA specimens. FNA is typically performed using a 22- or 25-gauge needle with a stylet under EUS guidance. The lesion is punctured with a stylet in place or slightly withdrawing the needle. After puncture, the stylet is pushed out of the needle tip and then the needle is moved to and fro within the lesion and this process is repeated for each needle pass. It is currently believed that the use of a stylet for EUS-FNA helps prevent clogging of the needle by gut wall tissue, which could limit the ability to aspirate cells from the target lesion. This may improve the quality of specimens and hence enhance the diagnostic yield of specimens obtained. This is a logical assumption, but there are no data demonstrating clearly that the use of a stylet increases the yield of EUS-FNA. At the present time, it is recommended that the stylet is re-inserted back into the needle prior to each FNA pass. The use of a stylet during EUS-FNA is cumbersome, time and energy consuming and increases the costs of EUS-FNA needle systems. In some circumstances, the stylet may actually make EUS-FNA very difficult as it may be impossible to advance or remove the stylet once the target has been punctured. This tends to occur when the echoendoscope or the needle is bent and a large (19 gauge) needle is being used. In addition, the data comparing the effectiveness of EUS-FNA with stylet to FNA without stylet is limited. Paquin et al compared the adequacy, the bloodiness, and the yield of FNA samples obtained with a stylet to FNA without a stylet. In this study, the use of stylet for EUS-FNA was associated with a reduced specimen adequacy and more bloody passes. 13 Thus the use of a stylet for EUS-FNA is questionable and needs further investigation. If the diagnostic yield, adequacy and quality of specimens obtained by EUS-FNA without a stylet is found to be equivalent to that with a stylet, this could potentially make a strong case for not using a stylet and thus making the procedure easier, more time- and cost-efficient. The hypothesis and specific aims of this prospective randomized controlled trial are as follows:
First hypothesis: There is no difference in the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet Specific Aim #1: To compare the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet
Second hypothesis: There is no difference in the diagnostic yield of malignancy in specimens obtained by EUS-FNA with a stylet compared with EUS-FNA without a stylet.
Specific Aim #2: To compare the diagnostic yield of malignancy in specimens obtained by EUS-FNA with and without a stylet.
Third hypothesis: An acceptable level of inter-observer agreement exists among cytopathologists in the assessment of specimens obtained from EUS-FNA with stylet and EUS-FNA without a stylet.
Specific Aim #3: To assess the inter-observer agreement among cytopathologists in the evaluation of specimens obtained from EUS-FNA with stylet and specimens obtained from EUS-FNA without a stylet.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-FNA with stylet | Active comparator | Device: EUS - FNA with styletEndoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) with stylet. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become a useful tool in the diagnostic evaluation of gastrointestinal tract lesions as well as other accessible organ sites and has found a wide use in the management of various gastrointestinal and non-gastrointestinal lesions. |
| EUS-FNA without stylet | Active comparator | Device: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA)Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) without stylet. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become a useful tool in the diagnostic evaluation of gastrointestinal tract lesions as well as other accessible organ sites and has found a wide use in the management of various gastrointestinal and non-gastrointestinal lesions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 years
- Presence of mediastinal or intra-abdominal lymphadenopathy, solid pancreatic mass, left adrenal mass, gastrointestinal submucosal lesions or liver mass confirmed by at least a single investigational modality - CT scan, magnetic resonance imaging, endoscopy.
- Capable of providing informed consent
Key exclusion criteria (4 listed)
- Severe coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000)
- Lesion unable to be sampled due to the presence of intervening blood vessels
- Results of EUS-FNA would not impact patient management
- Inability to provide informed consent
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 |
|---|---|---|
| EUS - FNA with styletAlso: FNA StyletEndoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) with stylet. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become a useful tool in the diagnostic evaluation of gastrointestinal tract lesions as well as other accessible organ sites and has found a wide use in the management of various gastrointestinal and non-gastrointestinal lesions. | Device | EUS-FNA with stylet |
| Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA)Also: FNA without styletEndoscopic ultrasound-guided fine-needle aspiration (EUS-FNA)without stylet. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become a useful tool in the diagnostic evaluation of gastrointestinal tract lesions as well as other accessible organ sites and has found a wide use in the management of various gastrointestinal and non-gastrointestinal lesions. | Device | EUS-FNA without stylet |
Primary outcome
To compare the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet
Time frame: 2 years
First hypothesis: There is no difference in the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet Specific Aim #1: To compare the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet
1 secondary outcome
To compare the diagnostic yield of malignancy in specimens obtained by EUS-FNA with and without a stylet.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2010.
- Derived from this study: PubMed 21514932Rastogi A, Wani S, Gupta N, Singh V, Gaddam S, Reddymasu S, Ulusarac O, Fan F, Romanas M, Dennis KL, Sharma P, Bansal A, Oropeza-Vail M, Olyaee M. A prospective, single-blind, randomized, controlled trial of EUS-guided FNA with and without a stylet. Gastrointest Endosc. 2011 Jul;74(1):58-64. doi: 10.1016/j.gie.2011.02.015. Epub 2011 Apr 23.
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.
Amit Rastogi, MD principal investigator
Kansas City Veterans Affairs Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS - FNA with stylet and Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in people with Mediastinal or Intra-abdominal Lymphadenopathy, and Pancreatic Masses,, run by American Society for Gastrointestinal Endoscopy at 2 sites in United States.
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 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 1 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet (time frame: 2 years). 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 NCT01213290, which also lists 1 linked publication.
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 1 Oct 2010.