Liver CancerNCT04309747
A Prospective, Multicenter Clinical Trial of Safety and Effectiveness of Nanosecond Knife Ablation for Liver Cancer
A study testing nanosecond knife liver cancer ablation in people with Liver Cancer, run by First Affiliated Hospital of Zhejiang University.
Trial summary
This is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cancer
- What is being tested?
- nanosecond knife liver cancer ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.
- Age: 18-75 years old, regardless of gender.
- Liver function: Child-Pugh A or B, or Child C will reach B.
- No serious heart, lung, brain and other organ dysfunction. Normal or nearly normal blood coagulation function. Prothrombin time does not exceed 50% of the normal control, and platelets are more than 50 × 109 / L.
- It is usually suitable for single tumor with a maximum diameter of ≤5cm, or the number of tumors of ≤3 and a maximum diameter of ≤3cm.
- For single tumors > 5 cm in diameter that cannot be surgically removed, or multiple tumors with a maximum diameter > 3 cm, local ablation can be used as p palliative comprehensive treatment.
- According to CT and MRI, there are no macrovascular and bile duct invasions visible by the naked eye.
- Patients signed informed consent to participate in the trial.
Who cannot join
- The lesion of liver cancer is huge or diffuse ;
- Merged portal vein to secondary branch tumor thrombus or hepatic vein tumor thrombus, invasion of nearby organs or distant metastasis;
- tumors located on the surface of the liver, of which more than 1/3 tumor size are bare;
- liver function: Child-pugh C, those could not improve after liver protective treatment;
- Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment;
- Uncorrectable coagulation dysfunction and severe haematological abnormalities, who tend to severe bleeding;
Show all 12Show fewer
- Refractory large amount of ascites and cachexia;
- active infection, especially inflammation of the biliary system;
- Severe failure of major organs such as liver, kidney, heart, lung and brain;
- Patients with unconsciousness or unable to cooperate with treatment;
- Subjects could not be followed up and fell off;
- Those who discontinued treatment, or the case records were incomplete for various reasons, and were determined by researchers to be unable to be evaluated.
Trial locations and contacts
No sites are listed yet.
About this study
This is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
Read the detailed description
The prospective, multi-center, single-arm clinical trial is to evaluate whether the nanosecond knife can achieve the effectiveness and safety of liver cancer ablation treatment. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. This clinical trial requires 190 subjects. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary outcome (the effective rate of nanosecond knife ablation for liver cancer) and secondary outcomes (partial response rate, secondary ablation rate, progression-free survival, overall survival rate, quality of life score, alpha-fetoprotein levels, technical success rate, local control rate, complication rate, device Use satisfaction of nanosecond knife ablation for liver cancer). The first 2-month follow-up after the operation, CT, MR, CEUS, liver function, tumor markers were reviewed monthly to observe the lesion necrosis and tumor marker changes. After that, tumor markers, CEUS, or three-phase CT/MRI of liver were examined every 2 to 3 months. After two years, tumor markers, CEUS, or three-phase CT/MRI of liver were examined every 3 to 6 months. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
- Conditions
- Liver Cancer
- Being tested
- nanosecond knife liver cancer ablation
- Keywords
- nanosecond knife, liver cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanosecond knife liver cancer ablationProcedure or surgery
This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
| Study group | Role | What they receive |
|---|---|---|
| nanosecond knife group | Experimental | This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups. Receives: Procedure: nanosecond knife liver cancer ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness analysis
The effective rate of nanosecond knife ablation for liver cancer
Measured: 12 months
Secondary outcomes (10)
Secondary validity analysis
partial response rate of nanosecond knife ablation for liver cancer
Measured: 12 months
Secondary validity analysis
secondary ablation rate of nanosecond knife ablation for liver cancer
Measured: 12 months
Secondary validity analysis
progression-free survival of nanosecond knife ablation for liver cancer
Measured: 12 months
Secondary validity analysis
overall survival rate of nanosecond knife ablation for liver cancer
Measured: 12 months
Secondary validity analysis
quality of life score of nanosecond knife ablation for liver cancer
Measured: 12 months
Secondary validity analysis
alpha-fetoprotein levels
Measured: 12 months
Secondary validity analysis
technical success rate of nanosecond knife ablation for liver cancer
Measured: 12 months
Secondary validity analysis
local control rate of nanosecond knife ablation for liver cancer
Measured: 12 months
Secondary validity analysis
complication rate of nanosecond knife ablation for liver cancer
Measured: 12 months
Secondary validity analysis
device Use satisfaction of nanosecond knife ablation for liver cancer
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
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 CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- Not applicable
- Intervention model
- Single group
- Model description
- To evaluate whether the nanosecond knife can achieve the effectiveness and safety of liver cancer ablation treatment.
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Principal investigator, Tian'an Jiang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309747
- Sponsor's protocol ID
- nanosecond001
- Other IDs
- nanosecond knife01
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
Publications
Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.
PubMed 18477802Gu YK, Luo RG, Huang JH, Si Tu QJ, Li XX, Gao F. Transarterial embolization ablation of hepatocellular carcinoma with a lipiodol-ethanol mixture. World J Gastroenterol. 2010 Dec 7;16(45):5766-72. doi: 10.3748/wjg.v16.i45.5766.
PubMed 21128329Bargellini I, Vignali C, Cioni R, Petruzzi P, Cicorelli A, Campani D, De Simone P, Filipponi F, Bartolozzi C. Hepatocellular carcinoma: CT for tumor response after transarterial chemoembolization in patients exceeding Milan criteria--selection parameter for liver transplantation. Radiology. 2010 Apr;255(1):289-300. doi: 10.1148/radiol.09090927.
PubMed 20308465Fruhling P, Nilsson A, Duraj F, Haglund U, Noren A. Single-center nonrandomized clinical trial to assess the safety and efficacy of irreversible electroporation (IRE) ablation of liver tumors in humans: Short to mid-term results. Eur J Surg Oncol. 2017 Apr;43(4):751-757. doi: 10.1016/j.ejso.2016.12.004. Epub 2017 Jan 11.
PubMed 28109674Distelmaier M, Barabasch A, Heil P, Kraemer NA, Isfort P, Keil S, Kuhl CK, Bruners P. Midterm Safety and Efficacy of Irreversible Electroporation of Malignant Liver Tumors Located Close to Major Portal or Hepatic Veins. Radiology. 2017 Dec;285(3):1023-1031. doi: 10.1148/radiol.2017161561. Epub 2017 Aug 11.
PubMed 28799842Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. doi: 10.1016/s0168-8278(01)00130-1. No abstract available.
PubMed 11592607Liu J, Fang C, Jin X, Tian G, Sun Z, Hong L, Pan J, Chen X, Zhao J, Cao H, Jiang T. Nanosecond pulsed electric field ablation-induced modulation of sphingolipid metabolism is associated with Ly6c2+ mononuclear phagocyte differentiation in liver cancer. Mol Oncol. 2023 Jun;17(6):1093-1111. doi: 10.1002/1878-0261.13372. Epub 2023 Jan 21.
PubMed 36587393Xu M, Xu D, Dong G, Ren Z, Zhang W, Aji T, Zhao Q, Chen X, Jiang T. The Safety and Efficacy of Nanosecond Pulsed Electric Field in Patients With Hepatocellular Carcinoma: A Prospective Phase 1 Clinical Study Protocol. Front Oncol. 2022 Jul 13;12:869316. doi: 10.3389/fonc.2022.869316. eCollection 2022.
PubMed 35912221
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Trial of Safety and Effectiveness of Nanosecond Knife Ablation for Liver Cancer
- ClinicalTrials.gov ID
- NCT04309747
- Acronym / sponsor ID
- nanosecond001
- Conditions
- Liver Cancer
- Keywords
- nanosecond knife, liver cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 16 Mar 2020 (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.
This is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
Detailed description
The prospective, multi-center, single-arm clinical trial is to evaluate whether the nanosecond knife can achieve the effectiveness and safety of liver cancer ablation treatment. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. This clinical trial requires 190 subjects. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary outcome (the effective rate of nanosecond knife ablation for liver cancer) and secondary outcomes (partial response rate, secondary ablation rate, progression-free survival, overall survival rate, quality of life score, alpha-fetoprotein levels, technical success rate, local control rate, complication rate, device Use satisfaction of nanosecond knife ablation for liver cancer). The first 2-month follow-up after the operation, CT, MR, CEUS, liver function, tumor markers were reviewed monthly to observe the lesion necrosis and tumor marker changes. After that, tumor markers, CEUS, or three-phase CT/MRI of liver were examined every 2 to 3 months. After two years, tumor markers, CEUS, or three-phase CT/MRI of liver were examined every 3 to 6 months. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To evaluate whether the nanosecond knife can achieve the effectiveness and safety of liver cancer ablation treatment.
| Arm | Type | Receives |
|---|---|---|
| nanosecond knife group | Experimental | Procedure: nanosecond knife liver cancer ablationThis trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.
- Age: 18-75 years old, regardless of gender.
- Liver function: Child-Pugh A or B, or Child C will reach B.
- No serious heart, lung, brain and other organ dysfunction. Normal or nearly normal blood coagulation function. Prothrombin time does not exceed 50% of the normal control, and platelets are more than 50 × 109 / L.
- It is usually suitable for single tumor with a maximum diameter of ≤5cm, or the number of tumors of ≤3 and a maximum diameter of ≤3cm.
Key exclusion criteria (12 listed)
- The lesion of liver cancer is huge or diffuse ;
- Merged portal vein to secondary branch tumor thrombus or hepatic vein tumor thrombus, invasion of nearby organs or distant metastasis;
- tumors located on the surface of the liver, of which more than 1/3 tumor size are bare;
- liver function: Child-pugh C, those could not improve after liver protective treatment;
- Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment;
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 |
|---|---|---|
| nanosecond knife liver cancer ablationThis trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups. | Procedure or surgery | nanosecond knife group |
Primary outcome
Effectiveness analysis
Time frame: 12 months
The effective rate of nanosecond knife ablation for liver cancer
10 secondary outcomes
Secondary validity analysis
Time frame: 12 months
Secondary validity analysis
Time frame: 12 months
Secondary validity analysis
Time frame: 12 months
Secondary validity analysis
Time frame: 12 months
Secondary validity analysis
Time frame: 12 months
Secondary validity analysis
Time frame: 12 months
Secondary validity analysis
Time frame: 12 months
Secondary validity analysis
Time frame: 12 months
Secondary validity analysis
Time frame: 12 months
Secondary validity analysis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Background: PubMed 18477802Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.
- Background: PubMed 21128329Gu YK, Luo RG, Huang JH, Si Tu QJ, Li XX, Gao F. Transarterial embolization ablation of hepatocellular carcinoma with a lipiodol-ethanol mixture. World J Gastroenterol. 2010 Dec 7;16(45):5766-72. doi: 10.3748/wjg.v16.i45.5766.
- Background: PubMed 20308465Bargellini I, Vignali C, Cioni R, Petruzzi P, Cicorelli A, Campani D, De Simone P, Filipponi F, Bartolozzi C. Hepatocellular carcinoma: CT for tumor response after transarterial chemoembolization in patients exceeding Milan criteria--selection parameter for liver transplantation. Radiology. 2010 Apr;255(1):289-300. doi: 10.1148/radiol.09090927.
- Background: PubMed 28109674Fruhling P, Nilsson A, Duraj F, Haglund U, Noren A. Single-center nonrandomized clinical trial to assess the safety and efficacy of irreversible electroporation (IRE) ablation of liver tumors in humans: Short to mid-term results. Eur J Surg Oncol. 2017 Apr;43(4):751-757. doi: 10.1016/j.ejso.2016.12.004. Epub 2017 Jan 11.
- Background: PubMed 28799842Distelmaier M, Barabasch A, Heil P, Kraemer NA, Isfort P, Keil S, Kuhl CK, Bruners P. Midterm Safety and Efficacy of Irreversible Electroporation of Malignant Liver Tumors Located Close to Major Portal or Hepatic Veins. Radiology. 2017 Dec;285(3):1023-1031. doi: 10.1148/radiol.2017161561. Epub 2017 Aug 11.
- Background: PubMed 11592607Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. doi: 10.1016/s0168-8278(01)00130-1. No abstract available.
- Derived from this study: PubMed 36587393Liu J, Fang C, Jin X, Tian G, Sun Z, Hong L, Pan J, Chen X, Zhao J, Cao H, Jiang T. Nanosecond pulsed electric field ablation-induced modulation of sphingolipid metabolism is associated with Ly6c2+ mononuclear phagocyte differentiation in liver cancer. Mol Oncol. 2023 Jun;17(6):1093-1111. doi: 10.1002/1878-0261.13372. Epub 2023 Jan 21.
- Derived from this study: PubMed 35912221Xu M, Xu D, Dong G, Ren Z, Zhang W, Aji T, Zhao Q, Chen X, Jiang T. The Safety and Efficacy of Nanosecond Pulsed Electric Field in Patients With Hepatocellular Carcinoma: A Prospective Phase 1 Clinical Study Protocol. Front Oncol. 2022 Jul 13;12:869316. doi: 10.3389/fonc.2022.869316. eCollection 2022.
- Individual participant dataSharing planned: Yes. This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
Questions about this trial
What is this clinical trial studying?
A study testing nanosecond knife liver cancer ablation in people with Liver Cancer, run by First Affiliated Hospital of Zhejiang University.
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 8 inclusion and 12 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Tian'an Jiang, PhD (18857127666, tiananjiang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness analysis (time frame: 12 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 NCT04309747, 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 17 Mar 2020.