Pulmonary NodulesNCT07277088
The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy
A study testing Conventional Manual Percutaneous Needle Biopsy in people with Pulmonary Nodules and Lung Cancer (Diagnosis), run by Jiayuan Sun at 1 site in China.
Trial summary
This prospective, single-center, non-inferiority, randomized controlled clinical trial aims to evaluate the efficacy and safety of a percutaneous interventional surgical control system in performing percutaneous needle biopsy of pulmonary nodules, compared with conventional manual biopsy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Nodules, Lung Cancer (Diagnosis), Percutaneous Needle Biopsy
- What is being tested?
- Conventional Manual Percutaneous Needle Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Age ranging from 18 years old to 80 years old, gender not restricted; 2) Patients with pulmonary nodules detected by chest CT, suspected to be malignant and judged by the researchers to require puncture biopsy for a clear diagnosis; 3) Pulmonary nodules with a long diameter greater than 8mm but not exceeding 30mm; 4) Have signed the informed consent form and voluntarily participate in this clinical study; 5) Can understand this research and cooperate with the research procedures, and can follow the requirements for follow-up observation.
Who cannot join
- 1) Subjects with irreparable coagulation dysfunction, infectious lesions on the puncture path, lesions adjacent to organs or surrounded by large blood vessels, suspected pulmonary echinococcosis on imaging, patients on mechanical ventilation (with a ventilator), liver multilocular echinococcosis, coma or other patients who are uncooperative; 2) Those judged by the investigators to be unsuitable for chest percutaneous puncture surgery: such as severe pulmonary hypertension, pulmonary bullae, chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis; 3) Poor overall condition (multiple systemic metastases, severe infection, high fever), obvious cachexia, severe dysfunction of important organs, severe anemia and nutritional metabolic disorders that cannot be improved in the short term; 4) Those allergic to contrast agents or anesthetics; 5) Implantation of pacemakers; 6) Pregnant or lactating women, or those with a fertility plan during the clinical trial; 7) Patients who cannot cooperate with the doctor to complete the puncture surgery, such as known drug or alcohol addiction, mental and neurological diseases, intellectual disability, psychological disorders, etc.; 8) Those participating in another drug or medical device clinical trial (within 3 months of drug clinical trial or within 1 month of medical device clinical trial); 9) The target lesion has been diagnosed or has received treatment; 10) Other situations that the investigator deems not suitable for this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Chest Hospital
Shanghai
Jiayuan Sun, PhD, 86-021-22200000, jysun1976@163.com
About this study
Official title: A Prospective, Single-center, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of the Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy
This prospective, single-center, non-inferiority, randomized controlled clinical trial aims to evaluate the efficacy and safety of a percutaneous interventional surgical control system in performing percutaneous needle biopsy of pulmonary nodules, compared with conventional manual biopsy. The study will be conducted at Shanghai Chest Hospital and plans to enroll 158 patients who meet the indications for percutaneous transthoracic needle biopsy (PTNB) and have no contraindications. Participants will be randomly assigned to one of two groups: the experimental group will undergo PTNB assisted by the percutaneous interventional surgical control system, while the control group will receive traditional manual PTNB. The primary endpoint is diagnostic yield; secondary endpoints include technical success rate, number of needle adjustments, puncture time, total procedure time, radiation dose, and complication rates.
- Conditions
- Pulmonary Nodules, Lung Cancer (Diagnosis), Percutaneous Needle Biopsy, Transthoracic Needle Biopsy, Robotic Assisted Intervention
- Being tested
- Percutaneous Needle Biopsy with Interventional Surgical Control System, Conventional Manual Percutaneous Needle Biopsy
- Keywords
- Percutaneous Needle Biopsy, Transthoracic Needle Biopsy, Pulmonary Nodules, Lung Cancer (Diagnosis), Robotic Assisted Intervention
- Medical subject headings
- Multiple Pulmonary Nodules, Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Needle Biopsy with Interventional Surgical Control SystemDiagnostic test
Also called Robotic assisted PTNB
Patients undergo percutaneous needle biopsy of pulmonary nodules with assistance from a percutaneous interventional surgical control system. The system performs automatically needle positioning and puncture.
Conventional Manual Percutaneous Needle BiopsyDiagnostic test
Also called Conventional PTNB
Patients receive traditional manual percutaneous needle biopsy of pulmonary nodules under CT guidance, operated by experienced interventional physicians.
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted group | Experimental | Patients undergo percutaneous needle biopsy of pulmonary nodules assisted by a percutaneous interventional surgical control system. The system performs automatically needle positioning and puncture. Receives: Diagnostic Test: Percutaneous Needle Biopsy with Interventional Surgical Control System |
| Manual group | Active comparator | Patients receive traditional manual percutaneous needle biopsy of pulmonary nodules, operated by experienced interventional physicians. Receives: Diagnostic Test: Conventional Manual Percutaneous Needle Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dianostic yield
Malignant lesions and specific benign lesions (e.g., fungal infections, tuberculosis, granulomas, etc.) are considered as having a definitive diagnosis.
Non-specific benign lesions (e.g., inflammation) are deemed diagnosed if they are confirmed by at least 6 months of follow-up, surgical resection, other biopsy methods, or radiological follow-up showing lesion shrinkage or disappearance.
Atypical cells or normal lung tissue are classified as non-diagnostic.
Measured: Up to 6 months after biopsy
Secondary outcomes (6)
Technical Success Rate
Defined as the successful positioning of the biopsy needle to the target lesion by the investigator based on intra-operative CT, without the use of other auxiliary puncture tools or needle guidance techniques. If yes, it is defined as technically successful. Technical success rate = (Number of patients with technical success / Total number of participants) × 100%.
Measured: Intra-operative
Number of Needle Adjustments
The number of needle adjustments from the moment the first needle tip touches the skin until the researcher confirms the puncture is successful, recorded by the investigator during the procedure. Any change in puncture direction, needle withdrawal, or needle removal after needle insertion should be counted.
Measured: Intra-operative
Puncture time
Refers to the duration from when the needle tip first reaches the skin puncture site to when successful puncture is confirmed (i.e., when the investigator judges that biopsy can be performed based on intra-operative CT scan).
Measured: Intra-operative
Procedural Time
Refers to the total time from when the patient is positioned to when the procedure is completed.
Measured: Intra-operative
Complication rate
Common complications of percutaneous needle biopsy include puncture site infection, pneumothorax, bleeding, hemoptysis, pleural reaction, etc. Rare complications include air embolism, cardiac tamponade, tumor seeding along the needle tract, nerve injury, etc.
Measured: Up to 6 months after biopsy
Radiation dose
The radiation dose received by the patient as recorded by the CT scan protocol during the biopsy procedure
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NodulesStudies 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
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiayuan Sun
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai United Imaging Intelligence Co., Ltd
- Responsible party
- Sponsor-investigator, Jiayuan Sun, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277088
- Sponsor's protocol ID
- IS25177
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anzidei M, Argiro R, Porfiri A, Boni F, Anile M, Zaccagna F, Vitolo D, Saba L, Napoli A, Leonardi A, Longo F, Venuta F, Bezzi M, Catalano C. Preliminary clinical experience with a dedicated interventional robotic system for CT-guided biopsies of lung lesions: a comparison with the conventional manual technique. Eur Radiol. 2015 May;25(5):1310-6. doi: 10.1007/s00330-014-3508-z. Epub 2014 Nov 23.
PubMed 25417130Appelbaum L, Sosna J, Nissenbaum Y, Benshtein A, Goldberg SN. Electromagnetic navigation system for CT-guided biopsy of small lesions. AJR Am J Roentgenol. 2011 May;196(5):1194-200. doi: 10.2214/AJR.10.5151.
PubMed 21512092Alexander ES, Petre EN, Bodard S, Marinelli B, Sarkar D, Cornelis FH. Comparison of a Patient-Mounted Needle-Driving Robotic System versus Single-Rotation CT Fluoroscopy to Perform CT-Guided Percutaneous Lung Biopsies. J Vasc Interv Radiol. 2024 Jun;35(6):859-864. doi: 10.1016/j.jvir.2024.02.023. Epub 2024 Mar 5.
PubMed 38447771Lee KH, Lim KY, Suh YJ, Hur J, Han DH, Kang MJ, Choo JY, Kim C, Kim JI, Yoon SH, Lee W, Park CM. Diagnostic Accuracy of Percutaneous Transthoracic Needle Lung Biopsies: A Multicenter Study. Korean J Radiol. 2019 Aug;20(8):1300-1310. doi: 10.3348/kjr.2019.0189.
PubMed 31339018Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e142S-e165S. doi: 10.1378/chest.12-2353.
PubMed 23649436Chang YY, Chen CK, Yeh YC, Wu MH. Diagnostic feasibility and safety of CT-guided core biopsy for lung nodules less than or equal to 8 mm: A single-institution experience. Eur Radiol. 2018 Feb;28(2):796-806. doi: 10.1007/s00330-017-5027-1. Epub 2017 Sep 7.
PubMed 28884222Horeweg N, van Rosmalen J, Heuvelmans MA, van der Aalst CM, Vliegenthart R, Scholten ET, ten Haaf K, Nackaerts K, Lammers JW, Weenink C, Groen HJ, van Ooijen P, de Jong PA, de Bock GH, Mali W, de Koning HJ, Oudkerk M. Lung cancer probability in patients with CT-detected pulmonary nodules: a prespecified analysis of data from the NELSON trial of low-dose CT screening. Lancet Oncol. 2014 Nov;15(12):1332-41. doi: 10.1016/S1470-2045(14)70389-4. Epub 2014 Oct 1.
PubMed 25282285Baldwin DR, Callister ME; Guideline Development Group. The British Thoracic Society guidelines on the investigation and management of pulmonary nodules. Thorax. 2015 Aug;70(8):794-8. doi: 10.1136/thoraxjnl-2015-207221. Epub 2015 Jul 1.
PubMed 26135833Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.
PubMed 39036382
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of the Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy
- ClinicalTrials.gov ID
- NCT07277088
- Acronym / sponsor ID
- IS25177
- Conditions
- Pulmonary Nodules, Lung Cancer (Diagnosis), Percutaneous Needle Biopsy, Transthoracic Needle Biopsy, Robotic Assisted Intervention
- Keywords
- Percutaneous Needle Biopsy, Transthoracic Needle Biopsy, Pulmonary Nodules, Lung Cancer (Diagnosis), Robotic Assisted Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Jiayuan SunUniversity, hospital or other
- Collaborators
- Shanghai United Imaging Intelligence Co., Ltd
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 11 Dec 2025 (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 prospective, single-center, non-inferiority, randomized controlled clinical trial aims to evaluate the efficacy and safety of a percutaneous interventional surgical control system in performing percutaneous needle biopsy of pulmonary nodules, compared with conventional manual biopsy. The study will be conducted at Shanghai Chest Hospital and plans to enroll 158 patients who meet the indications for percutaneous transthoracic needle biopsy (PTNB) and have no contraindications. Participants will be randomly assigned to one of two groups: the experimental group will undergo PTNB assisted by the percutaneous interventional surgical control system, while the control group will receive traditional manual PTNB. The primary endpoint is diagnostic yield; secondary endpoints include technical success rate, number of needle adjustments, puncture time, total procedure time, radiation dose, and complication rates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted group | Experimental | Diagnostic Test: Percutaneous Needle Biopsy with Interventional Surgical Control SystemPatients undergo percutaneous needle biopsy of pulmonary nodules assisted by a percutaneous interventional surgical control system. The system performs automatically needle positioning and puncture. |
| Manual group | Active comparator | Diagnostic Test: Conventional Manual Percutaneous Needle BiopsyPatients receive traditional manual percutaneous needle biopsy of pulmonary nodules, operated by experienced interventional physicians. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Age ranging from 18 years old to 80 years old, gender not restricted; 2) Patients with pulmonary nodules detected by chest CT, suspected to be malignant and judged by the researchers to require puncture biopsy for a clear diagnosis; 3) Pulmonary nodules with a long diameter greater than 8mm but not exceeding 30mm; 4) Have signed the informed consent form and voluntarily participate in this clinical study; 5) Can understand this research and cooperate with the research procedures, and can follow the requirements for follow-up observation.
Key exclusion criteria (1 listed)
- 1) Subjects with irreparable coagulation dysfunction, infectious lesions on the puncture path, lesions adjacent to organs or surrounded by large blood vessels, suspected pulmonary echinococcosis on imaging, patients on mechanical ventilation (with a ventilator), liver multilocular echinococcosis, coma or other patients who are uncooperative; 2) Those judged by the investigators to be unsuitable for chest percutaneous puncture surgery: such as severe pulmonary hypertension, pulmonary bullae, chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis; 3) Poor overall condition (multiple systemic metastases, severe infection, high fever), obvious cachexia, severe dysfunction of important organs, severe anemia and nutritional metabolic disorders that cannot be improved in the short term; 4) Those allergic to contrast agents or anesthetics; 5) Implantation of pacemakers; 6) Pregnant or lactating women, or those with a fertility plan during the clinical trial; 7) Patients who cannot cooperate with the doctor to complete the puncture surgery, such as known drug or alcohol addiction, mental and neurological diseases, intellectual disability, psychological disorders, etc.; 8) Those participating in another drug or medical device clinical trial (within 3 months of drug clinical trial or within 1 month of medical device clinical trial); 9) The target lesion has been diagnosed or has received treatment; 10) Other situations that the investigator deems not suitable for this clinical trial.
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 |
|---|---|---|
| Percutaneous Needle Biopsy with Interventional Surgical Control SystemAlso: Robotic assisted PTNBPatients undergo percutaneous needle biopsy of pulmonary nodules with assistance from a percutaneous interventional surgical control system. The system performs automatically needle positioning and puncture. | Diagnostic test | Robotic assisted group |
| Conventional Manual Percutaneous Needle BiopsyAlso: Conventional PTNBPatients receive traditional manual percutaneous needle biopsy of pulmonary nodules under CT guidance, operated by experienced interventional physicians. | Diagnostic test | Manual group |
Primary outcome
Dianostic yield
Time frame: Up to 6 months after biopsy
Malignant lesions and specific benign lesions (e.g., fungal infections, tuberculosis, granulomas, etc.) are considered as having a definitive diagnosis. Non-specific benign lesions (e.g., inflammation) are deemed diagnosed if they are confirmed by at least 6 months of follow-up, surgical resection, other biopsy methods, or radiological follow-up showing lesion shrinkage or disappearance. Atypical cells or normal lung tissue are classified as non-diagnostic.
6 secondary outcomes
Technical Success Rate
Time frame: Intra-operative
Number of Needle Adjustments
Time frame: Intra-operative
Puncture time
Time frame: Intra-operative
Procedural Time
Time frame: Intra-operative
Complication rate
Time frame: Up to 6 months after biopsy
Radiation dose
Time frame: Intra-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Results publication: PubMed 25417130Anzidei M, Argiro R, Porfiri A, Boni F, Anile M, Zaccagna F, Vitolo D, Saba L, Napoli A, Leonardi A, Longo F, Venuta F, Bezzi M, Catalano C. Preliminary clinical experience with a dedicated interventional robotic system for CT-guided biopsies of lung lesions: a comparison with the conventional manual technique. Eur Radiol. 2015 May;25(5):1310-6. doi: 10.1007/s00330-014-3508-z. Epub 2014 Nov 23.
- Results publication: PubMed 21512092Appelbaum L, Sosna J, Nissenbaum Y, Benshtein A, Goldberg SN. Electromagnetic navigation system for CT-guided biopsy of small lesions. AJR Am J Roentgenol. 2011 May;196(5):1194-200. doi: 10.2214/AJR.10.5151.
- Results publication: PubMed 38447771Alexander ES, Petre EN, Bodard S, Marinelli B, Sarkar D, Cornelis FH. Comparison of a Patient-Mounted Needle-Driving Robotic System versus Single-Rotation CT Fluoroscopy to Perform CT-Guided Percutaneous Lung Biopsies. J Vasc Interv Radiol. 2024 Jun;35(6):859-864. doi: 10.1016/j.jvir.2024.02.023. Epub 2024 Mar 5.
- Results publication: PubMed 31339018Lee KH, Lim KY, Suh YJ, Hur J, Han DH, Kang MJ, Choo JY, Kim C, Kim JI, Yoon SH, Lee W, Park CM. Diagnostic Accuracy of Percutaneous Transthoracic Needle Lung Biopsies: A Multicenter Study. Korean J Radiol. 2019 Aug;20(8):1300-1310. doi: 10.3348/kjr.2019.0189.
- Results publication: PubMed 23649436Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e142S-e165S. doi: 10.1378/chest.12-2353.
- Results publication: PubMed 28884222Chang YY, Chen CK, Yeh YC, Wu MH. Diagnostic feasibility and safety of CT-guided core biopsy for lung nodules less than or equal to 8 mm: A single-institution experience. Eur Radiol. 2018 Feb;28(2):796-806. doi: 10.1007/s00330-017-5027-1. Epub 2017 Sep 7.
- Results publication: PubMed 25282285Horeweg N, van Rosmalen J, Heuvelmans MA, van der Aalst CM, Vliegenthart R, Scholten ET, ten Haaf K, Nackaerts K, Lammers JW, Weenink C, Groen HJ, van Ooijen P, de Jong PA, de Bock GH, Mali W, de Koning HJ, Oudkerk M. Lung cancer probability in patients with CT-detected pulmonary nodules: a prespecified analysis of data from the NELSON trial of low-dose CT screening. Lancet Oncol. 2014 Nov;15(12):1332-41. doi: 10.1016/S1470-2045(14)70389-4. Epub 2014 Oct 1.
- Results publication: PubMed 26135833Baldwin DR, Callister ME; Guideline Development Group. The British Thoracic Society guidelines on the investigation and management of pulmonary nodules. Thorax. 2015 Aug;70(8):794-8. doi: 10.1136/thoraxjnl-2015-207221. Epub 2015 Jul 1.
- Results publication: PubMed 39036382Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Manual Percutaneous Needle Biopsy in people with Pulmonary Nodules and Lung Cancer (Diagnosis), run by Jiayuan Sun at 1 site in China.
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 1 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: opening soon, as of the sponsor's last update on 11 Dec 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun, PhD (86-021-22200000, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dianostic yield (time frame: Up to 6 months after biopsy). 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 NCT07277088, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.