HypersplenismNCT02261584
Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism
A study testing Microwave Thermal Coagulation and Partial Splenic Embolization in people with Hypersplenism, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare microwave thermal coagulation and partial splenic embolization in the management of hypersplenism in patients with cirrhosis. This study will be conducted on 40 patients with liver cirrhosis associated with splenomegaly and hypersplenism. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypersplenism
- What is being tested?
- Microwave Thermal Coagulation and Partial Splenic Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2014to Feb 2015
- 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
- Liver Cirrhosis
- Hypersplenism
Who cannot join
- Patients with bad performance scale.
- Patients with hepatic encephalopathy and tense ascites.
- Patient with active esophageal variceal bleeding .
- Patients with hypocellular bone marrow (BM).
- Patients with renal failure.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Hepatology and Tropical Medicine Research Institute
Cairo, Cairo Governorate
Asem A Elfert, MD, +20-122-437-8188, asem1967@yahoo.com
Asem A Elfert, MD
About this study
Official title: Comparative Study of Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism
The aim of this study is to compare microwave thermal coagulation and partial splenic embolization in the management of hypersplenism in patients with cirrhosis.
This study will be conducted on 40 patients with liver cirrhosis associated with splenomegaly and hypersplenism. The study will be done at the National Hepatology and Tropical Medicine Research Institute.
Read the detailed description
Liver cirrhosis or portal hypertension is frequently associated with congestive splenomegaly resulting in hypersplenism.
Hypersplenism can be defined as anemia, leukopenia, thrombocytopenia, or a combination of these resulting from excessive, splenic sequestration or pooling of blood cells, usually associated with clinical splenomegaly and always ameliorated by splenectomy.
Partial splenic embolization (PSE), which was first performed by Spigos et al in 1979, has been considered first-line therapy for hypersplenism in many institutions, and has been proposed as an effective alternative to splenectomy for improving peripheral blood cell counts. However, PSE is associated with many complications, including intermittent fever, abdominal pain, nausea, vomiting, post-embolization syndrome, splenic abscess, splenic rupture, pneumonia, refractory ascites, pleural effusion and gastrointestinal bleeding. To ensure a sustained and long-term increase in platelet and leucocytic counts, the splenic infarction rate needs to be greater than 50%. Thus, severe complications can ensue.
Thermal ablation methods using different energy sources, such as radiofrequency (RF), microwave (MW), or laser, were developed rapidly as minimally invasive techniques for the eradication of local tumor tissue within solid organs. There have been reports of the use of radiofrequency to ablate normal spleen, splenic injury, and splenomegaly.
Radiofrequency Ablation (RFA) had comparable efficacy and a better safety than PSE in the treatment of hypersplenism in patients with post hepatitis c cirrhosis.
MW ablation performed either laparoscopically or percutaneously is a safe, effective, and minimally invasive technique for the management of hypersplenism in patients with liver cirrhosis. It may significantly increase platelet count and white blood cells (WBC) count and improve hepatic blood supply with fewer complications. Ablating more than 40% of the splenic parenchyma may yield better long term results. This method may provide a new and promising minimally invasive alternative for treating hypersplenism.
The aim of this study is to compare microwave thermal coagulation and partial splenic embolization in the management of hypersplenism in patients with cirrhosis.
This study will be conducted on 40 patients with liver cirrhosis associated with splenomegaly and hypersplenism. The study will be done at the National Hepatology and Tropical Medicine Research Institute.
All patients will be subjected to thorough history taking, full clinical, lab, ultrasound/doppler, and upper endoscopic examination. Diagnosis has been based on peripheral blood count and confirmed with bone marrow examination.
Preoperative antibiotics will be given and correction of bleeding tendency with plasma and platelet transfusion will be done as required to get a prothrombin concentration more than 65% and platelet count more than 100,000.
- Conditions
- Hypersplenism
- Being tested
- Microwave Thermal Coagulation, Partial Splenic Embolization
- Medical subject headings
- Hypersplenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave Thermal CoagulationDevice
Also called Microwave
Microwave thermal coagulation of splenic parenchyma.
Partial Splenic EmbolizationDevice
Also called PSE
Femoral artery approach will be used for splenic artery catheterization with the tip of the catheter always well advanced selectively into the splenic artery. Embolizing agent will be injected in small increments. Arteriography in between divided doses will be done to document the extent of devascularization.
| Study group | Role | What they receive |
|---|---|---|
| Microwave Thermal Coagulation | Experimental | MW ablation performed either laparoscopically or percutaneously is a safe, effective, and minimally invasive technique for the management of hypersplenism in patients with liver cirrhosis. It may significantly increase platelet count and white blood cell (WBC) count and improve hepatic blood supply with fewer complications. Ablating more than 40% of the splenic parenchyma may yield better long term results. This method may provide a new and promising minimally invasive alternative for treating hypersplenism. Receives: Device: Microwave Thermal Coagulation |
| Partial Splenic Embolization Catheter | Experimental | Partial splenic embolization (PSE), which was first performed by Spigos et al in 1979, has been considered first-line therapy for hypersplenism in many institutions, and has been proposed as an effective alternative to splenectomy for improving peripheral blood cell counts. However, PSE is associated with many complications, including intermittent fever, abdominal pain, nausea, vomiting, post-embolization syndrome, splenic abscess, splenic rupture, pneumonia, refractory ascites, pleural effusion and gastrointestinal bleeding. To ensure a sustained and long-term increase in platelet and leucocytic counts, the splenic infarction rate needs to be greater than 50% (8). Thus, severe complications can ensue. Receives: Device: Partial Splenic Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with improvement of hypersplenism after microwave thermal coagulation of the spleen compared with partial splenic embolization.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (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 HypersplenismStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Shebl, Tanta University
- Investigators
- Asem A Elfert, MD, Principal investigator, Tanta Faculty of Medicine, ProfessorFat-heya E Assel, MD', Study director, Tanta Faculty of Medicine, ProfessorMohamed M Elkassas, Study director, Dr.Islam S Ismail, Study director, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261584
- Sponsor's protocol ID
- Microwave vs PSE
- Status last verified
- Oct 2014
- First submitted
- 26 Sep 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pursnani KG, Sillin LF, Kaplan DS. Effect of transjugular intrahepatic portosystemic shunt on secondary hypersplenism. Am J Surg. 1997 Mar;173(3):169-73. doi: 10.1016/s0002-9610(97)00006-8.
PubMed 9124620Spigos DG, Jonasson O, Mozes M, Capek V. Partial splenic embolization in the treatment of hypersplenism. AJR Am J Roentgenol. 1979 May;132(5):777-82. doi: 10.2214/ajr.132.5.777.
PubMed 107745Tajiri T, Onda M, Yoshida H, Mamada Y, Taniai N, Kumazaki T. Long-term hematological and biochemical effects of partial splenic embolization in hepatic cirrhosis. Hepatogastroenterology. 2002 Sep-Oct;49(47):1445-8.
PubMed 12239963Sangro B, Bilbao I, Herrero I, Corella C, Longo J, Beloqui O, Ruiz J, Zozaya JM, Quiroga J, Prieto J. Partial splenic embolization for the treatment of hypersplenism in cirrhosis. Hepatology. 1993 Aug;18(2):309-14.
PubMed 8340060N'Kontchou G, Seror O, Bourcier V, Mohand D, Ajavon Y, Castera L, Grando-Lemaire V, Ganne-Carrie N, Sellier N, Trinchet JC, Beaugrand M. Partial splenic embolization in patients with cirrhosis: efficacy, tolerance and long-term outcome in 32 patients. Eur J Gastroenterol Hepatol. 2005 Feb;17(2):179-84. doi: 10.1097/00042737-200502000-00008.
PubMed 15674095Hayashi H, Beppu T, Okabe K, Masuda T, Okabe H, Baba H. Risk factors for complications after partial splenic embolization for liver cirrhosis. Br J Surg. 2008 Jun;95(6):744-50. doi: 10.1002/bjs.6081.
PubMed 18412294Zhu K, Meng X, Qian J, Huang M, Li Z, Guan S, Jiang Z, Shan H. Partial splenic embolization for hypersplenism in cirrhosis: a long-term outcome in 62 patients. Dig Liver Dis. 2009 Jun;41(6):411-6. doi: 10.1016/j.dld.2008.10.005. Epub 2008 Dec 12.
PubMed 19070555Matsuoka T, Yamamoto A, Okuma T, Oyama Y, Nakamura K, Inoue Y. CT-guided percutaneous radiofrequency ablation of spleen: a preliminary study. AJR Am J Roentgenol. 2007 Apr;188(4):1044-6. doi: 10.2214/AJR.06.0641.
PubMed 17377043Felekouras E, Kontos M, Pissanou T, Pikoulis E, Drakos E, Papalambros E, Diamantis T, Bastounis E. A new spleen-preserving technique using radiofrequency ablation technology. J Trauma. 2004 Dec;57(6):1225-9. doi: 10.1097/01.ta.0000145072.31725.52.
PubMed 15625453Liu Q, Ma K, He Z, Dong J, Hua X, Huang X, Qiao L. Radiofrequency ablation for hypersplenism in patients with liver cirrhosis: a pilot study. J Gastrointest Surg. 2005 May-Jun;9(5):648-57. doi: 10.1016/j.gassur.2004.11.006.
PubMed 15862259Wasfi et al., Prospective randomized controlled study of Radiofrequency Ablation and Partial Splenic Embolization in the Treatment of Hypersplenism in patients with post-hepatitis C cirrhosis. AASLD poster DDW 2014, Chicago, USA
Liang P, Gao Y, Zhang H, Yu X, Wang Y, Duan Y, Shi W. Microwave ablation in the spleen for treatment of secondary hypersplenism: a preliminary study. AJR Am J Roentgenol. 2011 Mar;196(3):692-6. doi: 10.2214/AJR.10.4193.
PubMed 21343515Rasekhi AR, Naderifar M, Bagheri MH, Shahriari M, Foroutan H, Karimi M, Nabavizadeh SA. Radiofrequency ablation of the spleen in patients with thalassemia intermedia: a pilot study. AJR Am J Roentgenol. 2009 May;192(5):1425-9. doi: 10.2214/AJR.08.1382.
PubMed 19380572Crooks V, Waller S, Smith T, Hahn TJ. The use of the Karnofsky Performance Scale in determining outcomes and risk in geriatric outpatients. J Gerontol. 1991 Jul;46(4):M139-44. doi: 10.1093/geronj/46.4.m139.
PubMed 2071835
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism
- ClinicalTrials.gov ID
- NCT02261584
- Acronym / sponsor ID
- Microwave vs PSE
- Conditions
- Hypersplenism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 10 Oct 2014 (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.
The aim of this study is to compare microwave thermal coagulation and partial splenic embolization in the management of hypersplenism in patients with cirrhosis.
This study will be conducted on 40 patients with liver cirrhosis associated with splenomegaly and hypersplenism. The study will be done at the National Hepatology and Tropical Medicine Research Institute.
Detailed description
Liver cirrhosis or portal hypertension is frequently associated with congestive splenomegaly resulting in hypersplenism.
Hypersplenism can be defined as anemia, leukopenia, thrombocytopenia, or a combination of these resulting from excessive, splenic sequestration or pooling of blood cells, usually associated with clinical splenomegaly and always ameliorated by splenectomy.
Partial splenic embolization (PSE), which was first performed by Spigos et al in 1979, has been considered first-line therapy for hypersplenism in many institutions, and has been proposed as an effective alternative to splenectomy for improving peripheral blood cell counts. However, PSE is associated with many complications, including intermittent fever, abdominal pain, nausea, vomiting, post-embolization syndrome, splenic abscess, splenic rupture, pneumonia, refractory ascites, pleural effusion and gastrointestinal bleeding. To ensure a sustained and long-term increase in platelet and leucocytic counts, the splenic infarction rate needs to be greater than 50%. Thus, severe complications can ensue.
Thermal ablation methods using different energy sources, such as radiofrequency (RF), microwave (MW), or laser, were developed rapidly as minimally invasive techniques for the eradication of local tumor tissue within solid organs. There have been reports of the use of radiofrequency to ablate normal spleen, splenic injury, and splenomegaly.
Radiofrequency Ablation (RFA) had comparable efficacy and a better safety than PSE in the treatment of hypersplenism in patients with post hepatitis c cirrhosis.
MW ablation performed either laparoscopically or percutaneously is a safe, effective, and minimally invasive technique for the management of hypersplenism in patients with liver cirrhosis. It may significantly increase platelet count and white blood cells (WBC) count and improve hepatic blood supply with fewer complications. Ablating more than 40% of the splenic parenchyma may yield better long term results. This method may provide a new and promising minimally invasive alternative for treating hypersplenism.
The aim of this study is to compare microwave thermal coagulation and partial splenic embolization in the management of hypersplenism in patients with cirrhosis.
This study will be conducted on 40 patients with liver cirrhosis associated with splenomegaly and hypersplenism. The study will be done at the National Hepatology and Tropical Medicine Research Institute.
All patients will be subjected to thorough history taking, full clinical, lab, ultrasound/doppler, and upper endoscopic examination. Diagnosis has been based on peripheral blood count and confirmed with bone marrow examination.
Preoperative antibiotics will be given and correction of bleeding tendency with plasma and platelet transfusion will be done as required to get a prothrombin concentration more than 65% and platelet count more than 100,000.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microwave Thermal Coagulation | Experimental | Device: Microwave Thermal CoagulationMW ablation performed either laparoscopically or percutaneously is a safe, effective, and minimally invasive technique for the management of hypersplenism in patients with liver cirrhosis. It may significantly increase platelet count and white blood cell (WBC) count and improve hepatic blood supply with fewer complications. Ablating more than 40% of the splenic parenchyma may yield better long term results. This method may provide a new and promising minimally invasive alternative for treating hypersplenism. |
| Partial Splenic Embolization Catheter | Experimental | Device: Partial Splenic EmbolizationPartial splenic embolization (PSE), which was first performed by Spigos et al in 1979, has been considered first-line therapy for hypersplenism in many institutions, and has been proposed as an effective alternative to splenectomy for improving peripheral blood cell counts. However, PSE is associated with many complications, including intermittent fever, abdominal pain, nausea, vomiting, post-embolization syndrome, splenic abscess, splenic rupture, pneumonia, refractory ascites, pleural effusion and gastrointestinal bleeding. To ensure a sustained and long-term increase in platelet and leucocytic counts, the splenic infarction rate needs to be greater than 50% (8). Thus, severe complications can ensue. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Liver Cirrhosis
- Hypersplenism
Key exclusion criteria (5 listed)
- Patients with bad performance scale.
- Patients with hepatic encephalopathy and tense ascites.
- Patient with active esophageal variceal bleeding .
- Patients with hypocellular bone marrow (BM).
- Patients with renal failure.
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 |
|---|---|---|
| Microwave Thermal CoagulationAlso: MicrowaveMicrowave thermal coagulation of splenic parenchyma. | Device | Microwave Thermal Coagulation |
| Partial Splenic EmbolizationAlso: PSEFemoral artery approach will be used for splenic artery catheterization with the tip of the catheter always well advanced selectively into the splenic artery. Embolizing agent will be injected in small increments. Arteriography in between divided doses will be done to document the extent of devascularization. | Device | Partial Splenic Embolization Catheter |
Primary outcome
Percentage of participants with improvement of hypersplenism after microwave thermal coagulation of the spleen compared with partial splenic embolization.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
- Results publication: PubMed 9124620Pursnani KG, Sillin LF, Kaplan DS. Effect of transjugular intrahepatic portosystemic shunt on secondary hypersplenism. Am J Surg. 1997 Mar;173(3):169-73. doi: 10.1016/s0002-9610(97)00006-8.
- Results publication: PubMed 107745Spigos DG, Jonasson O, Mozes M, Capek V. Partial splenic embolization in the treatment of hypersplenism. AJR Am J Roentgenol. 1979 May;132(5):777-82. doi: 10.2214/ajr.132.5.777.
- Results publication: PubMed 12239963Tajiri T, Onda M, Yoshida H, Mamada Y, Taniai N, Kumazaki T. Long-term hematological and biochemical effects of partial splenic embolization in hepatic cirrhosis. Hepatogastroenterology. 2002 Sep-Oct;49(47):1445-8.
- Results publication: PubMed 8340060Sangro B, Bilbao I, Herrero I, Corella C, Longo J, Beloqui O, Ruiz J, Zozaya JM, Quiroga J, Prieto J. Partial splenic embolization for the treatment of hypersplenism in cirrhosis. Hepatology. 1993 Aug;18(2):309-14.
- Results publication: PubMed 15674095N'Kontchou G, Seror O, Bourcier V, Mohand D, Ajavon Y, Castera L, Grando-Lemaire V, Ganne-Carrie N, Sellier N, Trinchet JC, Beaugrand M. Partial splenic embolization in patients with cirrhosis: efficacy, tolerance and long-term outcome in 32 patients. Eur J Gastroenterol Hepatol. 2005 Feb;17(2):179-84. doi: 10.1097/00042737-200502000-00008.
- Results publication: PubMed 18412294Hayashi H, Beppu T, Okabe K, Masuda T, Okabe H, Baba H. Risk factors for complications after partial splenic embolization for liver cirrhosis. Br J Surg. 2008 Jun;95(6):744-50. doi: 10.1002/bjs.6081.
- Results publication: PubMed 19070555Zhu K, Meng X, Qian J, Huang M, Li Z, Guan S, Jiang Z, Shan H. Partial splenic embolization for hypersplenism in cirrhosis: a long-term outcome in 62 patients. Dig Liver Dis. 2009 Jun;41(6):411-6. doi: 10.1016/j.dld.2008.10.005. Epub 2008 Dec 12.
- Results publication: PubMed 17377043Matsuoka T, Yamamoto A, Okuma T, Oyama Y, Nakamura K, Inoue Y. CT-guided percutaneous radiofrequency ablation of spleen: a preliminary study. AJR Am J Roentgenol. 2007 Apr;188(4):1044-6. doi: 10.2214/AJR.06.0641.
- Results publication: PubMed 15625453Felekouras E, Kontos M, Pissanou T, Pikoulis E, Drakos E, Papalambros E, Diamantis T, Bastounis E. A new spleen-preserving technique using radiofrequency ablation technology. J Trauma. 2004 Dec;57(6):1225-9. doi: 10.1097/01.ta.0000145072.31725.52.
- Results publication: PubMed 15862259Liu Q, Ma K, He Z, Dong J, Hua X, Huang X, Qiao L. Radiofrequency ablation for hypersplenism in patients with liver cirrhosis: a pilot study. J Gastrointest Surg. 2005 May-Jun;9(5):648-57. doi: 10.1016/j.gassur.2004.11.006.
- Results publicationWasfi et al., Prospective randomized controlled study of Radiofrequency Ablation and Partial Splenic Embolization in the Treatment of Hypersplenism in patients with post-hepatitis C cirrhosis. AASLD poster DDW 2014, Chicago, USA
- Results publication: PubMed 21343515Liang P, Gao Y, Zhang H, Yu X, Wang Y, Duan Y, Shi W. Microwave ablation in the spleen for treatment of secondary hypersplenism: a preliminary study. AJR Am J Roentgenol. 2011 Mar;196(3):692-6. doi: 10.2214/AJR.10.4193.
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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.
Asem A Elfert, MD principal investigator
Tanta Faculty of Medicine, Professor
Fat-heya E Assel, MD' study director
Tanta Faculty of Medicine, Professor
Mohamed M Elkassas study director
Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave Thermal Coagulation and Partial Splenic Embolization in people with Hypersplenism, run by Tanta University at 1 site in Egypt.
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 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2014. 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 Egypt. 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 Asem A Elfert, MD (+20-122-437-8188, asem1967@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with improvement of hypersplenism after microwave thermal coagulation of the spleen compared with partial splenic embolization. (time frame: 6 months). 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 NCT02261584, 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 10 Oct 2014.