Liver CarcinomaCIRTNCT02305459
CIRSE Registry for SIR-Spheres Therapy
An observational study of Liver Carcinoma, run by Cardiovascular and Interventional Radiological Society of Europe at 1 site in Austria.
Trial summary
The administration of SIR-Spheres microspheres (yttrium-90 resin microspheres) is a form of selective internal radiation therapy (SIRT) for the treatment of patients with primary and secondary liver tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Carcinoma
- What is being tested?
- Yttrium-90 loaded SIR-Spheres microspheres and QLQ-C30 with HCC module
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 1,051 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2014to 1 Jan 2020
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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
Study population: Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres as part of the treatment determined by the treating clinician.
Who may be able to join
- Treatment of liver tumour with SIR-spheres microspheres
- Primary or secondary liver tumours
- Signed informed consent form
- 18 years or older
Who cannot join
- Under 18 years
Trial locations and contacts
1 site in 1 country.
Austria1 site
Cardiovascular and Interventional Radiological Society of Europe
Vienna, 1010
About this study
The administration of SIR-Spheres microspheres (yttrium-90 resin microspheres) is a form of selective internal radiation therapy (SIRT) for the treatment of patients with primary and secondary liver tumours. The primary objective is to observe the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives are to observe safety and effectiveness of SIR-Spheres treatment in terms of adverse events, Overall Survival (OS), Progression-free survival (PFS), technical considerations, liver PFS and Quality of Life (QoL) + subgroup analyses
Read the detailed description
Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. Following administration, 94% of the radiation is delivered in 11 days. Previous reports on the safety and efficacy of yttrium-90 resin microspheres for the treatment of primary and secondary liver tumours are very promising. In order to further improve the understanding of this therapy in its true clinical setting, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) initiated the CIRSE Registry for SIR-Spheres Therapy (CIRT), a phase 4 observational study that aims to collect robust data on the real-life clinical practice of radioembolisation with SIR-Spheres microspheres. Further, using the quality of life questionnaire QLQ-C30 with its hepatocellular carcinoma module (developed and verified by the European Organisation of Research and Treatment of Cancer (EORTC)), CIRT aims to collect data on the quality of life of patients treated with SIR-Spheres microspheres.
- Conditions
- Liver Carcinoma
- Being tested
- Yttrium-90 loaded SIR-Spheres microspheres, QLQ-C30 with HCC module
- Keywords
- SIRT, microcatheter, primary liver tumor, secondary liver tumor, radioembolisation, QLQ-C30, CIRSE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium-90 loaded SIR-Spheres microspheresDevice
Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. SIR-Spheres microspheres are manufactured by Sirtex Medical.
QLQ-C30 with HCC moduleBehavioural
In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT will incorporate a quality-of-life questionnaire. CIRT will be using EORTC's QLQ-C30 with HCC Module to measure changes in the quality of life of the patient. The quality-of-life questionnaire will be offered to the patient before the treatment, shortly after the treatment (as soon as possible) and at every follow-up. Filling out the quality-of-life questionnaire is entirely voluntary for the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Radioembolisation | All Patients treated with Radioembolisation with yttrium-90 loaded SIR-Spheres microspheres are asked to be enrolled. In no way will participation in the registry influence the way in which the patient is treated or will it influence the quality of the treatment.
In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT will incorporate a quality-of-life questionnaire. CIRT will be using EORTC's QLQ-C30 with the Hepatocellular carcinoma (HCC) Module to measure changes in the quality of life of the patient. Receives: Device: Yttrium-90 loaded SIR-Spheres microspheres; Behavioral: QLQ-C30 with HCC module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the clinical context in which SIR-Spheres are applied
Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures
Measured: Baseline, follow-up every 3 months until 24 months
Secondary outcomes (5)
Adverse events
Adverse events per follow-up
Measured: Every 3 months until 24 months
QLQ-C30
Quality of life using QLQ-C30 from baseline until 24 months
Measured: Every 3 months until 24 months
Overall survival
Time till death
Measured: Every 3 months until 24 months
PFS
Time to progression
Measured: Every 3 months until 24 months
Hepatic PFS
Time to progression
Measured: Every 3 months until 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startNov 2014
- Primary completion1 Jan 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Liver CarcinomaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,051 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Helmberger, Prof, Principal investigator, München Klinik Bogenhausen,Englschalkinger Str. 77, D-81925 München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305459
- Sponsor's protocol ID
- CIRT
- Acronym
- CIRT
- Status last verified
- May 2026
- First submitted
- 11 Nov 2014
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reimer P, Vilgrain V, Arnold D, Balli T, Golfieri R, Loffroy R, Mosconi C, Ronot M, Sengel C, Schaefer N, Maleux G, Munneke G, Peynircioglu B, Sangro B, Kaufmann N, Urdaniz M, Pereira H, de Jong N, Helmberger T. Factors Impacting Survival After Transarterial Radioembolization in Patients with Unresectable Intrahepatic Cholangiocarcinoma: A Combined Analysis of the Prospective CIRT Studies. Cardiovasc Intervent Radiol. 2024 Mar;47(3):310-324. doi: 10.1007/s00270-023-03657-x. Epub 2024 Feb 6.
PubMed 38321223Schaefer N, Grozinger G, Pech M, Pfammatter T, Soydal C, Arnold D, Kolligs F, Maleux G, Munneke G, Peynircioglu B, Sangro B, Pereira H, Zeka B, de Jong N, Helmberger T; CIRT Principal Investigators. Prognostic Factors for Effectiveness Outcomes After Transarterial Radioembolization in Metastatic Colorectal Cancer: Results From the Multicentre Observational Study CIRT. Clin Colorectal Cancer. 2022 Dec;21(4):285-296. doi: 10.1016/j.clcc.2022.09.002. Epub 2022 Sep 20.
PubMed 36270925Maleux G, Albrecht T, Arnold D, Bargellini I, Cianni R, Helmberger T, Kolligs F, Munneke G, Peynircioglu B, Sangro B, Schaefer N, Pereira H, Zeka B, de Jong N, Bilbao JI; CIRT Principal Investigators. Predictive Factors for Adverse Event Outcomes After Transarterial Radioembolization with Yttrium-90 Resin Microspheres in Europe: Results from the Prospective Observational CIRT Study. Cardiovasc Intervent Radiol. 2023 Jul;46(7):852-867. doi: 10.1007/s00270-023-03391-4. Epub 2023 Mar 13.
PubMed 36914788Kolligs F, Arnold D, Golfieri R, Pech M, Peynircioglu B, Pfammatter T, Ronot M, Sangro B, Schaefer N, Maleux G, Munneke G, Pereira H, Zeka B, de Jong N, Helmberger T; CIRT Principal Investigators. Factors impacting survival after transarterial radioembolization in patients with hepatocellular carcinoma: Results from the prospective CIRT study. JHEP Rep. 2022 Nov 25;5(2):100633. doi: 10.1016/j.jhepr.2022.100633. eCollection 2023 Feb.
PubMed 36593888Helmberger T, Golfieri R, Pech M, Pfammatter T, Arnold D, Cianni R, Maleux G, Munneke G, Pellerin O, Peynircioglu B, Sangro B, Schaefer N, de Jong N, Bilbao JI; On behalf of the CIRT Steering Committee; On behalf of the CIRT Principal Investigators. Clinical Application of Trans-Arterial Radioembolization in Hepatic Malignancies in Europe: First Results from the Prospective Multicentre Observational Study CIRSE Registry for SIR-Spheres Therapy (CIRT). Cardiovasc Intervent Radiol. 2021 Jan;44(1):21-35. doi: 10.1007/s00270-020-02642-y. Epub 2020 Sep 21.
PubMed 32959085Helmberger T, Arnold D, Bilbao JI, de Jong N, Maleux G, Nordlund A, Peynircioglu B, Sangro B, Sharma RA, Walk A. Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study. JMIR Res Protoc. 2020 Apr 22;9(4):e16296. doi: 10.2196/16296.
PubMed 32319960Authors: Thomas Helmberger, Dirk Arnold, Romaric Loffroy, Maxime Ronot, Bruno Sangro, Frank Kolligs, Olivier Pellerin, Geert Maleux, Bora Peynircioglu, Niklaus Schaefer, Jose Ignacio Bilbao, Niels de Jong, Milan Geyer, Bleranda Zeka, Maria Urdaniz, Valerie Vilgrain Article Title: Hepatocellular carcinoma patients treated with TARE monotherapy or combination therapy with curative intent: a retrospective, exploratory analysis of two European prospective studies Journal Name: CVIR Oncology Publication Date: 2026 Volume number: 2:5 . : . .
Schaefer N, Arnold D, de Jong N, Geyer M, Urdaniz M, Helmberger T. Aspartate Aminotransferase to Platelet Index (APRI) as a Prognostic Factor for Overall Survival After TARE Y90 Resin Microspheres in Primary Liver Cancer Patients: Results from the European, Prospective Observational Study CIRT. Cardiovasc Intervent Radiol. 2026 May 27. doi: 10.1007/s00270-026-04483-7. Online ahead of print.
PubMed 42203908
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIRSE Registry for SIR-Spheres Therapy
- ClinicalTrials.gov ID
- NCT02305459
- Acronym / sponsor ID
- CIRT / CIRT
- Conditions
- Liver Carcinoma
- Keywords
- SIRT, microcatheter, primary liver tumor, secondary liver tumor, radioembolisation, QLQ-C30, CIRSE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,051 participants (actual)
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of EuropeUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 2 Dec 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 administration of SIR-Spheres microspheres (yttrium-90 resin microspheres) is a form of selective internal radiation therapy (SIRT) for the treatment of patients with primary and secondary liver tumours. The primary objective is to observe the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives are to observe safety and effectiveness of SIR-Spheres treatment in terms of adverse events, Overall Survival (OS), Progression-free survival (PFS), technical considerations, liver PFS and Quality of Life (QoL) + subgroup analyses
Detailed description
Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. Following administration, 94% of the radiation is delivered in 11 days. Previous reports on the safety and efficacy of yttrium-90 resin microspheres for the treatment of primary and secondary liver tumours are very promising. In order to further improve the understanding of this therapy in its true clinical setting, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) initiated the CIRSE Registry for SIR-Spheres Therapy (CIRT), a phase 4 observational study that aims to collect robust data on the real-life clinical practice of radioembolisation with SIR-Spheres microspheres. Further, using the quality of life questionnaire QLQ-C30 with its hepatocellular carcinoma module (developed and verified by the European Organisation of Research and Treatment of Cancer (EORTC)), CIRT aims to collect data on the quality of life of patients treated with SIR-Spheres microspheres.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Radioembolisation | – | Device: Yttrium-90 loaded SIR-Spheres microspheres, Behavioral: QLQ-C30 with HCC moduleAll Patients treated with Radioembolisation with yttrium-90 loaded SIR-Spheres microspheres are asked to be enrolled. In no way will participation in the registry influence the way in which the patient is treated or will it influence the quality of the treatment. In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT will incorporate a quality-of-life questionnaire. CIRT will be using EORTC's QLQ-C30 with the Hepatocellular carcinoma (HCC) Module to measure changes in the quality of life of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres as part of the treatment determined by the treating clinician.
Key inclusion criteria (4 listed)
- Treatment of liver tumour with SIR-spheres microspheres
- Primary or secondary liver tumours
- Signed informed consent form
- 18 years or older
Key exclusion criteria (1 listed)
- Under 18 years
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 |
|---|---|---|
| Yttrium-90 loaded SIR-Spheres microspheresSelective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. SIR-Spheres microspheres are manufactured by Sirtex Medical. | Device | Patients treated with Radioembolisation |
| QLQ-C30 with HCC moduleIn order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT will incorporate a quality-of-life questionnaire. CIRT will be using EORTC's QLQ-C30 with HCC Module to measure changes in the quality of life of the patient. The quality-of-life questionnaire will be offered to the patient before the treatment, shortly after the treatment (as soon as possible) and at every follow-up. Filling out the quality-of-life questionnaire is entirely voluntary for the patient. | Behavioural | Patients treated with Radioembolisation |
Primary outcome
Description of the clinical context in which SIR-Spheres are applied
Time frame: Baseline, follow-up every 3 months until 24 months
Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures
5 secondary outcomes
Adverse events
Time frame: Every 3 months until 24 months
QLQ-C30
Time frame: Every 3 months until 24 months
Overall survival
Time frame: Every 3 months until 24 months
PFS
Time frame: Every 3 months until 24 months
Hepatic PFS
Time frame: Every 3 months until 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 38321223Reimer P, Vilgrain V, Arnold D, Balli T, Golfieri R, Loffroy R, Mosconi C, Ronot M, Sengel C, Schaefer N, Maleux G, Munneke G, Peynircioglu B, Sangro B, Kaufmann N, Urdaniz M, Pereira H, de Jong N, Helmberger T. Factors Impacting Survival After Transarterial Radioembolization in Patients with Unresectable Intrahepatic Cholangiocarcinoma: A Combined Analysis of the Prospective CIRT Studies. Cardiovasc Intervent Radiol. 2024 Mar;47(3):310-324. doi: 10.1007/s00270-023-03657-x. Epub 2024 Feb 6.
- Results publication: PubMed 36270925Schaefer N, Grozinger G, Pech M, Pfammatter T, Soydal C, Arnold D, Kolligs F, Maleux G, Munneke G, Peynircioglu B, Sangro B, Pereira H, Zeka B, de Jong N, Helmberger T; CIRT Principal Investigators. Prognostic Factors for Effectiveness Outcomes After Transarterial Radioembolization in Metastatic Colorectal Cancer: Results From the Multicentre Observational Study CIRT. Clin Colorectal Cancer. 2022 Dec;21(4):285-296. doi: 10.1016/j.clcc.2022.09.002. Epub 2022 Sep 20.
- Results publication: PubMed 36914788Maleux G, Albrecht T, Arnold D, Bargellini I, Cianni R, Helmberger T, Kolligs F, Munneke G, Peynircioglu B, Sangro B, Schaefer N, Pereira H, Zeka B, de Jong N, Bilbao JI; CIRT Principal Investigators. Predictive Factors for Adverse Event Outcomes After Transarterial Radioembolization with Yttrium-90 Resin Microspheres in Europe: Results from the Prospective Observational CIRT Study. Cardiovasc Intervent Radiol. 2023 Jul;46(7):852-867. doi: 10.1007/s00270-023-03391-4. Epub 2023 Mar 13.
- Results publication: PubMed 36593888Kolligs F, Arnold D, Golfieri R, Pech M, Peynircioglu B, Pfammatter T, Ronot M, Sangro B, Schaefer N, Maleux G, Munneke G, Pereira H, Zeka B, de Jong N, Helmberger T; CIRT Principal Investigators. Factors impacting survival after transarterial radioembolization in patients with hepatocellular carcinoma: Results from the prospective CIRT study. JHEP Rep. 2022 Nov 25;5(2):100633. doi: 10.1016/j.jhepr.2022.100633. eCollection 2023 Feb.
- Results publication: PubMed 32959085Helmberger T, Golfieri R, Pech M, Pfammatter T, Arnold D, Cianni R, Maleux G, Munneke G, Pellerin O, Peynircioglu B, Sangro B, Schaefer N, de Jong N, Bilbao JI; On behalf of the CIRT Steering Committee; On behalf of the CIRT Principal Investigators. Clinical Application of Trans-Arterial Radioembolization in Hepatic Malignancies in Europe: First Results from the Prospective Multicentre Observational Study CIRSE Registry for SIR-Spheres Therapy (CIRT). Cardiovasc Intervent Radiol. 2021 Jan;44(1):21-35. doi: 10.1007/s00270-020-02642-y. Epub 2020 Sep 21.
- Results publication: PubMed 32319960Helmberger T, Arnold D, Bilbao JI, de Jong N, Maleux G, Nordlund A, Peynircioglu B, Sangro B, Sharma RA, Walk A. Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study. JMIR Res Protoc. 2020 Apr 22;9(4):e16296. doi: 10.2196/16296.
- Results publicationAuthors: Thomas Helmberger, Dirk Arnold, Romaric Loffroy, Maxime Ronot, Bruno Sangro, Frank Kolligs, Olivier Pellerin, Geert Maleux, Bora Peynircioglu, Niklaus Schaefer, Jose Ignacio Bilbao, Niels de Jong, Milan Geyer, Bleranda Zeka, Maria Urdaniz, Valerie Vilgrain Article Title: Hepatocellular carcinoma patients treated with TARE monotherapy or combination therapy with curative intent: a retrospective, exploratory analysis of two European prospective studies Journal Name: CVIR Oncology Publication Date: 2026 Volume number: 2:5 . : . .
- Derived from this study: PubMed 42203908Schaefer N, Arnold D, de Jong N, Geyer M, Urdaniz M, Helmberger T. Aspartate Aminotransferase to Platelet Index (APRI) as a Prognostic Factor for Overall Survival After TARE Y90 Resin Microspheres in Primary Liver Cancer Patients: Results from the European, Prospective Observational Study CIRT. Cardiovasc Intervent Radiol. 2026 May 27. doi: 10.1007/s00270-026-04483-7. Online ahead of print.
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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.
Thomas Helmberger, Prof principal investigator
München Klinik Bogenhausen,Englschalkinger Str. 77, D-81925 München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Carcinoma, run by Cardiovascular and Interventional Radiological Society of Europe at 1 site in Austria.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 14 May 2026. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Description of the clinical context in which SIR-Spheres are applied (time frame: Baseline, follow-up every 3 months until 24 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 NCT02305459, which also lists 8 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 14 May 2026.