RFANCT07625189
EUS-Guided Ablation (RFA and MWA) for Pancreatic and Other Gastrointestinal Lesions Registry
An observational study of RFA and Microwave Ablation, run by West Virginia University at 1 site in United States.
Trial summary
This is a single-center, investigator-initiated, prospective observational registry that will collect longitudinal clinical data on adult patients (≥18 years) undergoing endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) or microwave ablation (MWA) for pancreatic and other gastrointestinal/hepatobiliary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RFA, Microwave Ablation, Pancreatic Lesion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to Mar 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The purpose of this registry is to create a longitudinal clinical dataset describing patients who undergo EUS-guided RFA or MWA as part of routine care and to explore clinical outcomes and factors associated with those outcomes.
Who may be able to join
- Adults ≥ 18 years of age.
- Diagnosis of a pancreatic premalignant lesion or malignancy, and other gastrointestinal or hepatobiliary lesion for which EUS-guided ablation is planned as part of standard clinical care.
- At least one clinically identified target lesion for which RFA or MWA is performed.
Who cannot join
- In the judgment of the treating clinician, inclusion in the registry would not be appropriate
- The individual is expected to be unable to complete routine clinical follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
West Virginia University
Morgantown, West Virginia, 26505
About this study
Official title: Prospective Observational Registry of EUS-Guided Ablation (RFA and MWA) for Pancreatic and Other Gastrointestinal Lesions
This is a single-center, investigator-initiated, prospective observational registry that will collect longitudinal clinical data on adult patients (≥18 years) undergoing endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) or microwave ablation (MWA) for pancreatic and other gastrointestinal/hepatobiliary lesions as part of routine clinical care. The registry will not alter standard-of-care management. Data will be abstracted from the medical record and routine clinical systems. Primary outcomes include change in target lesion size on clinically obtained imaging and overall survival following ablation. Secondary outcomes include changes in tumor biomarkers, adverse events, non-target lesion changes, and patient-reported symptoms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 1 Month in Target Lesion Size
Change in tumor size (cm) from baseline to 1 month, assessed by imaging.
Measured: Baseline to 1 month
Change From Baseline to 3 Months in Target Lesion Size
Change in tumor size (cm) from baseline to 3 months, assessed by imaging.
Measured: Baseline to 3 months
Change From Baseline to 6 Months in Target Lesion Size
Change in tumor size (cm) from baseline to 6 months, assessed by imaging.
Measured: Baseline to 6 months
Change From Baseline to 12 Months in Target Lesion Size
Change in tumor size (cm) from baseline to 12 months, assessed by imaging.
Measured: Baseline to 12 months
Overall Survival
Overall survival defined as the time from ablation to death from any cause. Participants still alive will be censored at last known follow-up.
Measured: From ablation to death or last follow-up, assessed up to 1 year
Overall Survival
Overall survival defined as the time from ablation to death from any cause. Participants still alive will be censored at last known follow-up.
Measured: From ablation to death or last follow-up, assessed up to 3 year
Secondary outcomes (20)
Change From Baseline to 1 Month in Serum CA 19-9 Concentration
Change in serum CA 19-9 concentration from baseline to 1 month.
Measured: Baseline to 1 month
Change From Baseline to 3 Month in Serum CA 19-9 Concentration
Change in serum CA 19-9 concentration from baseline to 3 month.
Measured: Baseline to 3 month
Change From Baseline to 6 Month in Serum CA 19-9 Concentration
Change in serum CA 19-9 concentration from baseline to 6 month.
Measured: Baseline to 6 month
Change From Baseline to 12 Month in Serum CA 19-9 Concentration
Change in serum CA 19-9 concentration from baseline to 12 month.
Measured: Baseline to 12 month
Change From Baseline to 1 Month in Serum CEA Concentration
Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 1 month.
Measured: Baseline to 1 month
Change From Baseline to 3 Month in Serum CEA Concentration
Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 3 month.
Measured: Baseline to 3 month
Change From Baseline to 6 Month in Serum CEA Concentration
Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 6 month.
Measured: Baseline to 6 month
Change From Baseline to 12 Month in Serum CEA Concentration
Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 12 month.
Measured: Baseline to 12 month
Change From Baseline to 1 Month in Size of Non-Target Lesions
Change in size (cm) of non-target lesions from baseline to 1 month, assessed by imaging.
Measured: Baseline to 1 month
Change From Baseline to 3 Months in Size of Non-Target Lesions
Change in size (cm) of non-target lesions from baseline to 3 months, assessed by imaging.
Measured: Baseline to 3 months
Change From Baseline to 6 Months in Size of Non-Target Lesions
Change in size (cm) of non-target lesions from baseline to 6 months, assessed by imaging.
Measured: Baseline to 6 months
Change From Baseline to 12 Months in Size of Non-Target Lesions
Change in size (cm) of non-target lesions from baseline to 12 months, assessed by imaging.
Measured: Baseline to 12 months
Number of Participants With Procedure-Related Adverse Events (1 Month)
Number of participants experiencing one or more procedure-related adverse events within 1 month after ablation. Adverse events will be assessed according to standard criteria.
Measured: Up to 1 month after ablation procedure
Number of Participants With Procedure-Related Adverse Events (3 Months)
Number of participants experiencing one or more procedure-related adverse events within 3 months after ablation. Adverse events will be assessed according to standard criteria.
Measured: Up to 3 months after ablation procedure
Number of Participants With Procedure-Related Adverse Events (6 Months)
Number of participants experiencing one or more procedure-related adverse events within 6 months after ablation. Adverse events will be assessed according to standard criteria.
Measured: Up to 6 months after ablation procedure
Number of Participants With Procedure-Related Adverse Events (12 Months)
Number of participants experiencing one or more procedure-related adverse events within 12 months after ablation. Adverse events will be assessed according to standard criteria.
Measured: Up to 12 months after ablation procedure
Change From Baseline to 1 Month in Quality of Life Score (EORTC QLQ-C30)
Change in overall quality of life score from baseline to 1 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life.
Measured: Baseline to 1 month
Change From Baseline to 3 Month in Quality of Life Score (EORTC QLQ-C30)
Change in overall quality of life score from baseline to 3 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life.
Measured: Baseline to 3 month
Change From Baseline to 6 Month in Quality of Life Score (EORTC QLQ-C30)
Change in overall quality of life score from baseline to 6 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life.
Measured: Baseline to 6 month
Change From Baseline to 12 Month in Quality of Life Score (EORTC QLQ-C30)
Change in overall quality of life score from baseline to 12 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life.
Measured: Baseline to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start10 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for RFAStudies of the same condition, open and under way.
- More trials run by West Virginia 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shailendra Singh, West Virginia University
- Investigators
- Shailendra Singh, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625189
- Sponsor's protocol ID
- STUDY00000041
- Status last verified
- May 2026
- First submitted
- 2 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Robles-Medranda C, Arevalo-Mora M, Oleas R, Alcivar-Vasquez J, Del Valle R. Novel EUS-guided microwave ablation of an unresectable pancreatic neuroendocrine tumor. VideoGIE. 2022 Jan 19;7(2):74-76. doi: 10.1016/j.vgie.2021.10.009. eCollection 2022 Feb.
PubMed 35146230Wray CJ, O'Brien B, Cen P, Rowe JH, Faraoni EY, Bailey JM, Rubin E, Tammisetti VS, Thosani N. EUS-guided radiofrequency ablation for pancreatic adenocarcinoma. Gastrointest Endosc. 2024 Oct;100(4):759-766. doi: 10.1016/j.gie.2024.04.2926. Epub 2024 May 8.
PubMed 38729313Kongkam P, Tantitanawat K, Kerr S, Lopimpisuth C, Tiankanon K, Angsuwatcharakon P, Ridtitid W, Mekaroonkamol P, Teeyapun N, Tanasanvimon S, Treeprasertsuk S, Kullavanijaya P, Sriuranpong V, Rerknimitr R, Luangsukrerk T. One-year survival rate of unresectable pancreatic cancer size 4 cm or smaller treated with or without EUS-radiofrequency ablation. Gastrointest Endosc. 2025 Dec;102(6):883-887. doi: 10.1016/j.gie.2025.06.008. Epub 2025 Jul 17.
PubMed 40680897Bidani K, Marinovic AG, Moond V, Harne P, Broder A, Thosani N. Treatment of Pancreatic Neuroendocrine Tumors: Beyond Traditional Surgery and Targeted Therapy. J Clin Med. 2025 May 13;14(10):3389. doi: 10.3390/jcm14103389.
PubMed 40429384Wood LD, Canto MI, Jaffee EM, Simeone DM. Pancreatic Cancer: Pathogenesis, Screening, Diagnosis, and Treatment. Gastroenterology. 2022 Aug;163(2):386-402.e1. doi: 10.1053/j.gastro.2022.03.056. Epub 2022 Apr 7.
PubMed 35398344Mohan A, Prasanth M, Saeed NA, Shehzadi T, Hasan ZW, Khan NN, Tanush D, Aminpoor H. Advancements in endoscopic closure techniques for gastrointestinal luminal defects comparative perspectives on OTSC, endo suturing, TTS clips, and X-Tack. Ann Med Surg (Lond). 2025 Jul 16;87(8):5077-5086. doi: 10.1097/MS9.0000000000003571. eCollection 2025 Aug.
PubMed 40787569Hasan ZW, Shehzadi T, Mohan A, Rehman AU, Muskan F, Zia M, Lal PM, Aminpoor H, Karimi H, Kumar V, Tejwaney U, Kumar S. Percutaneous, transpapillary, and transmural drainage in acute cholecystitis: a comparative analysis of techniques, stent selection, and clinical. Ann Med Surg (Lond). 2025 Jul 30;87(8):5056-5061. doi: 10.1097/MS9.0000000000003527. eCollection 2025 Aug.
PubMed 40787544Slodkowski M, Wronski M, Karkocha D, Kraj L, Smigielska K, Jachnis A. Current Approaches for the Curative-Intent Surgical Treatment of Pancreatic Ductal Adenocarcinoma. Cancers (Basel). 2023 Apr 30;15(9):2584. doi: 10.3390/cancers15092584.
PubMed 37174050Rahib L, Coffin T, Kenner B. Factors Driving Pancreatic Cancer Survival Rates. Pancreas. 2025 Jul 1;54(6):e530-e536. doi: 10.1097/MPA.0000000000002489.
PubMed 40245290Park W, Chawla A, O'Reilly EM. Pancreatic Cancer: A Review. JAMA. 2021 Sep 7;326(9):851-862. doi: 10.1001/jama.2021.13027.
PubMed 34547082
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Registry of EUS-Guided Ablation (RFA and MWA) for Pancreatic and Other Gastrointestinal Lesions
- ClinicalTrials.gov ID
- NCT07625189
- Acronym / sponsor ID
- STUDY00000041
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 4 Jun 2026 (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 single-center, investigator-initiated, prospective observational registry that will collect longitudinal clinical data on adult patients (≥18 years) undergoing endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) or microwave ablation (MWA) for pancreatic and other gastrointestinal/hepatobiliary lesions as part of routine clinical care. The registry will not alter standard-of-care management. Data will be abstracted from the medical record and routine clinical systems. Primary outcomes include change in target lesion size on clinically obtained imaging and overall survival following ablation. Secondary outcomes include changes in tumor biomarkers, adverse events, non-target lesion changes, and patient-reported symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The purpose of this registry is to create a longitudinal clinical dataset describing patients who undergo EUS-guided RFA or MWA as part of routine care and to explore clinical outcomes and factors associated with those outcomes.
Key inclusion criteria (3 listed)
- Adults ≥ 18 years of age.
- Diagnosis of a pancreatic premalignant lesion or malignancy, and other gastrointestinal or hepatobiliary lesion for which EUS-guided ablation is planned as part of standard clinical care.
- At least one clinically identified target lesion for which RFA or MWA is performed.
Key exclusion criteria (2 listed)
- In the judgment of the treating clinician, inclusion in the registry would not be appropriate
- The individual is expected to be unable to complete routine clinical follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline to 1 Month in Target Lesion Size
Time frame: Baseline to 1 month
Change in tumor size (cm) from baseline to 1 month, assessed by imaging.
Change From Baseline to 3 Months in Target Lesion Size
Time frame: Baseline to 3 months
Change in tumor size (cm) from baseline to 3 months, assessed by imaging.
Change From Baseline to 6 Months in Target Lesion Size
Time frame: Baseline to 6 months
Change in tumor size (cm) from baseline to 6 months, assessed by imaging.
Change From Baseline to 12 Months in Target Lesion Size
Time frame: Baseline to 12 months
Change in tumor size (cm) from baseline to 12 months, assessed by imaging.
Overall Survival
Time frame: From ablation to death or last follow-up, assessed up to 1 year
Overall survival defined as the time from ablation to death from any cause. Participants still alive will be censored at last known follow-up.
Overall Survival
Time frame: From ablation to death or last follow-up, assessed up to 3 year
Overall survival defined as the time from ablation to death from any cause. Participants still alive will be censored at last known follow-up.
20 secondary outcomes
Change From Baseline to 1 Month in Serum CA 19-9 Concentration
Time frame: Baseline to 1 month
Change From Baseline to 3 Month in Serum CA 19-9 Concentration
Time frame: Baseline to 3 month
Change From Baseline to 6 Month in Serum CA 19-9 Concentration
Time frame: Baseline to 6 month
Change From Baseline to 12 Month in Serum CA 19-9 Concentration
Time frame: Baseline to 12 month
Change From Baseline to 1 Month in Serum CEA Concentration
Time frame: Baseline to 1 month
Change From Baseline to 3 Month in Serum CEA Concentration
Time frame: Baseline to 3 month
Change From Baseline to 6 Month in Serum CEA Concentration
Time frame: Baseline to 6 month
Change From Baseline to 12 Month in Serum CEA Concentration
Time frame: Baseline to 12 month
Change From Baseline to 1 Month in Size of Non-Target Lesions
Time frame: Baseline to 1 month
Change From Baseline to 3 Months in Size of Non-Target Lesions
Time frame: Baseline to 3 months
Change From Baseline to 6 Months in Size of Non-Target Lesions
Time frame: Baseline to 6 months
Change From Baseline to 12 Months in Size of Non-Target Lesions
Time frame: Baseline to 12 months
Number of Participants With Procedure-Related Adverse Events (1 Month)
Time frame: Up to 1 month after ablation procedure
Number of Participants With Procedure-Related Adverse Events (3 Months)
Time frame: Up to 3 months after ablation procedure
Number of Participants With Procedure-Related Adverse Events (6 Months)
Time frame: Up to 6 months after ablation procedure
Number of Participants With Procedure-Related Adverse Events (12 Months)
Time frame: Up to 12 months after ablation procedure
Change From Baseline to 1 Month in Quality of Life Score (EORTC QLQ-C30)
Time frame: Baseline to 1 month
Change From Baseline to 3 Month in Quality of Life Score (EORTC QLQ-C30)
Time frame: Baseline to 3 month
Change From Baseline to 6 Month in Quality of Life Score (EORTC QLQ-C30)
Time frame: Baseline to 6 month
Change From Baseline to 12 Month in Quality of Life Score (EORTC QLQ-C30)
Time frame: Baseline to 12 month
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 4 Jun 2026.
- Background: PubMed 35146230Robles-Medranda C, Arevalo-Mora M, Oleas R, Alcivar-Vasquez J, Del Valle R. Novel EUS-guided microwave ablation of an unresectable pancreatic neuroendocrine tumor. VideoGIE. 2022 Jan 19;7(2):74-76. doi: 10.1016/j.vgie.2021.10.009. eCollection 2022 Feb.
- Background: PubMed 38729313Wray CJ, O'Brien B, Cen P, Rowe JH, Faraoni EY, Bailey JM, Rubin E, Tammisetti VS, Thosani N. EUS-guided radiofrequency ablation for pancreatic adenocarcinoma. Gastrointest Endosc. 2024 Oct;100(4):759-766. doi: 10.1016/j.gie.2024.04.2926. Epub 2024 May 8.
- Background: PubMed 40680897Kongkam P, Tantitanawat K, Kerr S, Lopimpisuth C, Tiankanon K, Angsuwatcharakon P, Ridtitid W, Mekaroonkamol P, Teeyapun N, Tanasanvimon S, Treeprasertsuk S, Kullavanijaya P, Sriuranpong V, Rerknimitr R, Luangsukrerk T. One-year survival rate of unresectable pancreatic cancer size 4 cm or smaller treated with or without EUS-radiofrequency ablation. Gastrointest Endosc. 2025 Dec;102(6):883-887. doi: 10.1016/j.gie.2025.06.008. Epub 2025 Jul 17.
- Background: PubMed 40429384Bidani K, Marinovic AG, Moond V, Harne P, Broder A, Thosani N. Treatment of Pancreatic Neuroendocrine Tumors: Beyond Traditional Surgery and Targeted Therapy. J Clin Med. 2025 May 13;14(10):3389. doi: 10.3390/jcm14103389.
- Background: PubMed 35398344Wood LD, Canto MI, Jaffee EM, Simeone DM. Pancreatic Cancer: Pathogenesis, Screening, Diagnosis, and Treatment. Gastroenterology. 2022 Aug;163(2):386-402.e1. doi: 10.1053/j.gastro.2022.03.056. Epub 2022 Apr 7.
- Background: PubMed 40787569Mohan A, Prasanth M, Saeed NA, Shehzadi T, Hasan ZW, Khan NN, Tanush D, Aminpoor H. Advancements in endoscopic closure techniques for gastrointestinal luminal defects comparative perspectives on OTSC, endo suturing, TTS clips, and X-Tack. Ann Med Surg (Lond). 2025 Jul 16;87(8):5077-5086. doi: 10.1097/MS9.0000000000003571. eCollection 2025 Aug.
- Background: PubMed 40787544Hasan ZW, Shehzadi T, Mohan A, Rehman AU, Muskan F, Zia M, Lal PM, Aminpoor H, Karimi H, Kumar V, Tejwaney U, Kumar S. Percutaneous, transpapillary, and transmural drainage in acute cholecystitis: a comparative analysis of techniques, stent selection, and clinical. Ann Med Surg (Lond). 2025 Jul 30;87(8):5056-5061. doi: 10.1097/MS9.0000000000003527. eCollection 2025 Aug.
- Background: PubMed 37174050Slodkowski M, Wronski M, Karkocha D, Kraj L, Smigielska K, Jachnis A. Current Approaches for the Curative-Intent Surgical Treatment of Pancreatic Ductal Adenocarcinoma. Cancers (Basel). 2023 Apr 30;15(9):2584. doi: 10.3390/cancers15092584.
- Background: PubMed 40245290Rahib L, Coffin T, Kenner B. Factors Driving Pancreatic Cancer Survival Rates. Pancreas. 2025 Jul 1;54(6):e530-e536. doi: 10.1097/MPA.0000000000002489.
- Background: PubMed 34547082Park W, Chawla A, O'Reilly EM. Pancreatic Cancer: A Review. JAMA. 2021 Sep 7;326(9):851-862. doi: 10.1001/jama.2021.13027.
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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.
Shailendra Singh, MD principal investigator
West Virginia University
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 RFA and Microwave Ablation, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 4 Jun 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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 Zim Warda Hasan (364-203-1900, zh00027@mix.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to 1 Month in Target Lesion Size (time frame: Baseline to 1 month). The study lists 6 primary outcomes in all. 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 NCT07625189, which also lists 10 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 4 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.