EchocardiographyNCT06324903
Role of Echocardiography in Optimization of Cardiac Catheterization in Children With Congenital Heart Disease
An observational study of Echocardiography, run by Assiut University.
Trial summary
Delineate and evaluate the role of echocardiography in children with congenital heart disease undergoing cardiac catheterization in the pediatric cardiology unit of Assiut university hospitals. 1. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Echocardiography
- What is being tested?
- echocardiography and percutaneous cardiac catheterization
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 30 Oct 2025
- 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 1 month to 18 years
- All sexes
- Child, Adult
Study population: Infants and children age from 1 month to 18 years old. Hospitalized patients in pediatric cardiology unit, Assiut University Hospitals, who are prepared for cardiac catheterization.
Who may be able to join
- All infants and children from 1month to 18 years old with congenital cardiac defects indicated for cardiac catheterization
Who cannot join
- • Patients with complex cardiac disease,
- Patients with a history of renal disease,
- Patient who are less than 1 month,
- Parental refusal to participate in the research.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Echocardiography in Optimization of Cardiac Catheterization Performance in Children With Congenital Heart Disease
Delineate and evaluate the role of echocardiography in children with congenital heart disease undergoing cardiac catheterization in the pediatric cardiology unit of Assiut university hospitals.
- To improve diagnostic accuracy by creating a systematic approach for image acquisition and interpretation across different procedural timepoints.
- To promote consistent hemodynamic evaluations to reliably assess cardiac function and blood flow.
- To enable optimized procedural planning and intraprocedural guidance via comprehensive delineation of anatomy and pathophysiology.
- To facilitate standardized longitudinal monitoring after interventions to evaluate outcomes and detect complications.
Read the detailed description
Congenital heart disease is estimated to affect approximately 1% of live births, underscoring the profound impact of this set of cardiac malformations . Echocardiography serves as the cornerstone imaging modality utilized in all aspects of care in this patient population - from initial diagnosis, to informing surgical and transcatheter interventions, to longitudinal surveillance . Recent decades have witnessed major advancements in the catheter-based treatment of Congenital heart disease , sparing patients from more invasive open-heart procedures in select cases . Transcatheter closure of defects such as atrial septal defects , ventricular septal defects and patent ductus arteriosus have become mainstream interventions . However, the complexity of Congenital heart disease anatomy necessitates meticulous procedural planning and guidance to achieve optimal outcomes following these catheterizations .
Importance of Standardized Echocardiography Protocols Echocardiography is invaluable before, during and after transcatheter interventions in patients with congenital heart disease. Precise delineation of anatomy facilitates appropriate procedure selection and planning - including choice of access, devices, and imaging guidance . Intraprocedural transesophageal echocardiography offers real-time visualization for device positioning and deployment as well as identification of complications . Post-intervention surveillance detects residual lesions, enables assessment of ventricular function and valvular regurgitation, and monitors for complications such as thrombosis or device erosion .
Despite extensive guidelines on the echocardiographic assessment of congenital heart disease, substantial inter-institutional variability persists in imaging for catheter-based procedures . Standardized protocols have demonstrated improvements in accuracy, consistency, and quality . However, adoption of such protocols is lagging. This gap highlights the pressing need for evidence-based protocols to optimize echocardiography practices.
This proposed protocol focuses on pre-catheterization, intraprocedural and post-catheterization transthoracic echocardiography and transesophageal echocardiography for common interventions - atrial septal defects closure, ventricular septal defects closure and patent ductus arteriosus closure. It provides comprehensive recommendations on essential views, measurements, and documentation. The protocol allows modularity to adapt components across different interventions. Wider adoption has the potential to substantially improve consistency, accuracy, patient safety and quality. Further studies are imperative to demonstrate the impact of implementing such standardized protocols. This initiative represents an important step towards advancing care for pediatric catheterizations.
- Conditions
- Echocardiography
- Being tested
- echocardiography and percutaneous cardiac catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiography and percutaneous cardiac catheterizationOther
pre- cardiac catheterization, intraprocedural and post-catheterization echocardiography.
What is being measured
The primary outcome is the main question the study is designed to answer.
congenital heart defect dimensions in mm,
congenital heart defect dimensions in mm which are patent ductus arteriosus (PDA), ventricular septal defect (VSD), atrial septal defect (ASD) dimensions in (mm) millimeter.
comparing pre-catheter and intra-catheter procedure measurement measuring by transthoracic echocardiography 24 hours pre-catheter then intra-catheter by transesophageal echocardiography and transcatheter angiography.
Measured: 2 DAYS
pressure gradient in mmHg across valve
pressure gradient in mmHg which are valvular pulmonary stenosis (VPS) pressure gradient in mmHg. pulmonary hypertension measured in mmHg. comparing pre-catheter and intra-catheter procedure measurement measuring by transthoracic echocardiography 24 hours pre-catheter then intra-catheter by transesophageal echocardiography and transcatheter angiography.
Measured: 2 DAYS
Secondary outcomes (2)
cardiac function by measuring fraction shortening (FS) % in percent
echocardiography measurements of cardiac systolic function for 24 hours pre-catheterization studies, for 48 hours post-catheterization studies and on 6 months follow up ( LVEDD in mm, LVESD in mm, , FS in % ( Fractional shortening (FS) = LVEDD-LVESD/LVESD ×100 )
Measured: 6 months
cardiac function TAPSV in cm/sec
cardiac function of right side of the heart TAPSV in cm/sec, echocardiography tissue doppler measurements of cardiac systolic function for 24 hours pre-catheterization studies, for 48 hours post-catheterization studies and on 6 months follow up TAPSV in cm/sec.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdelmonem Abdelgalil Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324903
- Sponsor's protocol ID
- echo cath CHD
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol. 2011 Nov 15;58(21):2241-7. doi: 10.1016/j.jacc.2011.08.025.
PubMed 22078432Sachdeva R, Valente AM, Armstrong AK, Cook SC, Han BK, Lopez L, Lui GK, Pickard SS, Powell AJ, Bhave NM, Sachdeva R, Valente AM, Pickard SS, Baffa JM, Banka P, Cohen SB, Glickstein JS, Kanter JP, Kanter RJ, Kim YY, Kipps AK, Latson LA, Lin JP, Parra DA, Rodriguez FH 3rd, Saarel EV, Srivastava S, Stephenson EA, Stout KK, Zaidi AN. ACC/AHA/ASE/HRS/ISACHD/SCAI/SCCT/SCMR/SOPE 2020 Appropriate Use Criteria for Multimodality Imaging During the Follow-Up Care of Patients With Congenital Heart Disease: A Report of the American College of Cardiology Solution Set Oversight Committee and Appropriate Use Criteria Task Force, American Heart Association, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Pediatric Echocardiography. J Am Coll Cardiol. 2020 Feb 18;75(6):657-703. doi: 10.1016/j.jacc.2019.10.002. Epub 2020 Jan 6. No abstract available.
PubMed 31918898Ramlawi B. The Era of Catheter-Based and Minimally Invasive Cardiac Surgery. Methodist Debakey Cardiovasc J. 2016 Jan-Mar;12(1):3. doi: 10.14797/mdcj-12-1-3. No abstract available.
PubMed 27127554Turner ME, Bouhout I, Petit CJ, Kalfa D. Transcatheter Closure of Atrial and Ventricular Septal Defects: JACC Focus Seminar. J Am Coll Cardiol. 2022 Jun 7;79(22):2247-2258. doi: 10.1016/j.jacc.2021.08.082.
PubMed 35654496Divekar AA, Arar YM, Clark S, Tandon A, Zellers TM, Veeram Reddy SR. Transcatheter Device Therapy and the Integration of Advanced Imaging in Congenital Heart Disease. Children (Basel). 2022 Apr 2;9(4):497. doi: 10.3390/children9040497.
PubMed 35455541Avesani M, Kang SL, Jalal Z, Thambo JB, Iriart X. Renaissance of Cardiac Imaging to Assist Percutaneous Interventions in Congenital Heart Diseases:The Role of Three-Dimensional Echocardiography and Multimodality Imaging. Front Pediatr. 2022 May 19;10:894472. doi: 10.3389/fped.2022.894472. eCollection 2022.
PubMed 35664875Kenny D. Interventional Cardiology for Congenital Heart Disease. Korean Circ J. 2018 May;48(5):350-364. doi: 10.4070/kcj.2018.0064. Epub 2018 Mar 29.
PubMed 29671282Maragiannis D, Little SH. Interventional imaging: the role of echocardiography. Methodist Debakey Cardiovasc J. 2014 Jul-Sep;10(3):172-7. doi: 10.14797/mdcj-10-3-172.
PubMed 25574345Zhang X, Gosnell J, Nainamalai V, Page S, Huang S, Haw M, Peng B, Vettukattil J, Jiang J. Advances in TEE-Centric Intraprocedural Multimodal Image Guidance for Congenital and Structural Heart Disease. Diagnostics (Basel). 2023 Sep 18;13(18):2981. doi: 10.3390/diagnostics13182981.
PubMed 37761348Ludomirsky A. The use of echocardiography in pediatric interventional cardiac catheterization procedures. J Interv Cardiol. 1995 Oct;8(5):569-78. doi: 10.1111/j.1540-8183.1995.tb00584.x.
PubMed 10159521Little SH, Rigolin VH, Garcia-Sayan E, Hahn RT, Hung J, Mackensen GB, Mankad S, Quader N, Saric M. Recommendations for Special Competency in Echocardiographic Guidance of Structural Heart Disease Interventions: From the American Society of Echocardiography. J Am Soc Echocardiogr. 2023 Apr;36(4):350-365. doi: 10.1016/j.echo.2023.01.014. Epub 2023 Feb 24.
PubMed 36841670Broder MS, Gibbs SN, Yermilov I. An Adaptation of the RAND/UCLA Modified Delphi Panel Method in the Time of COVID-19. J Healthc Leadersh. 2022 May 20;14:63-70. doi: 10.2147/JHL.S352500. eCollection 2022.
PubMed 35634010Sharma AK, Agarwal A, Sinha SK, Razi MM, Pandey U, Shukla P, Thakur R, Verma CM, Bansal RK, Krishna V. An echocardiographic evaluation to determine the immediate and short-term changes in biventricular systolic and diastolic functions after PDA device closure-an observational analytical prospective study (echo- PDA study). Indian Heart J. 2021 Sep-Oct;73(5):617-621. doi: 10.1016/j.ihj.2021.06.017. Epub 2021 Jul 6.
PubMed 34627579Hou M, Qian W, Wang B, Zhou W, Zhang J, Ding Y, Xu Q, Huang J, Shen J, Cao L, Lv H, Sun L. Echocardiographic Prediction of Left Ventricular Dysfunction After Transcatheter Patent Ductus Arteriosus Closure in Children. Front Pediatr. 2019 Oct 15;7:409. doi: 10.3389/fped.2019.00409. eCollection 2019.
PubMed 31681709
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Echocardiography in Optimization of Cardiac Catheterization Performance in Children With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06324903
- Acronym / sponsor ID
- echo cath CHD
- Conditions
- Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 22 Mar 2024 (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.
Delineate and evaluate the role of echocardiography in children with congenital heart disease undergoing cardiac catheterization in the pediatric cardiology unit of Assiut university hospitals.
- To improve diagnostic accuracy by creating a systematic approach for image acquisition and interpretation across different procedural timepoints.
- To promote consistent hemodynamic evaluations to reliably assess cardiac function and blood flow.
- To enable optimized procedural planning and intraprocedural guidance via comprehensive delineation of anatomy and pathophysiology.
- To facilitate standardized longitudinal monitoring after interventions to evaluate outcomes and detect complications.
Detailed description
Congenital heart disease is estimated to affect approximately 1% of live births, underscoring the profound impact of this set of cardiac malformations . Echocardiography serves as the cornerstone imaging modality utilized in all aspects of care in this patient population - from initial diagnosis, to informing surgical and transcatheter interventions, to longitudinal surveillance . Recent decades have witnessed major advancements in the catheter-based treatment of Congenital heart disease , sparing patients from more invasive open-heart procedures in select cases . Transcatheter closure of defects such as atrial septal defects , ventricular septal defects and patent ductus arteriosus have become mainstream interventions . However, the complexity of Congenital heart disease anatomy necessitates meticulous procedural planning and guidance to achieve optimal outcomes following these catheterizations .
Importance of Standardized Echocardiography Protocols Echocardiography is invaluable before, during and after transcatheter interventions in patients with congenital heart disease. Precise delineation of anatomy facilitates appropriate procedure selection and planning - including choice of access, devices, and imaging guidance . Intraprocedural transesophageal echocardiography offers real-time visualization for device positioning and deployment as well as identification of complications . Post-intervention surveillance detects residual lesions, enables assessment of ventricular function and valvular regurgitation, and monitors for complications such as thrombosis or device erosion .
Despite extensive guidelines on the echocardiographic assessment of congenital heart disease, substantial inter-institutional variability persists in imaging for catheter-based procedures . Standardized protocols have demonstrated improvements in accuracy, consistency, and quality . However, adoption of such protocols is lagging. This gap highlights the pressing need for evidence-based protocols to optimize echocardiography practices.
This proposed protocol focuses on pre-catheterization, intraprocedural and post-catheterization transthoracic echocardiography and transesophageal echocardiography for common interventions - atrial septal defects closure, ventricular septal defects closure and patent ductus arteriosus closure. It provides comprehensive recommendations on essential views, measurements, and documentation. The protocol allows modularity to adapt components across different interventions. Wider adoption has the potential to substantially improve consistency, accuracy, patient safety and quality. Further studies are imperative to demonstrate the impact of implementing such standardized protocols. This initiative represents an important step towards advancing care for pediatric catheterizations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Infants and children age from 1 month to 18 years old. Hospitalized patients in pediatric cardiology unit, Assiut University Hospitals, who are prepared for cardiac catheterization.
Key inclusion criteria (1 listed)
- All infants and children from 1month to 18 years old with congenital cardiac defects indicated for cardiac catheterization
Key exclusion criteria (4 listed)
- • Patients with complex cardiac disease,
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 |
|---|---|---|
| echocardiography and percutaneous cardiac catheterizationpre- cardiac catheterization, intraprocedural and post-catheterization echocardiography. | Other | – |
Primary outcome
congenital heart defect dimensions in mm,
Time frame: 2 DAYS
congenital heart defect dimensions in mm which are patent ductus arteriosus (PDA), ventricular septal defect (VSD), atrial septal defect (ASD) dimensions in (mm) millimeter. comparing pre-catheter and intra-catheter procedure measurement measuring by transthoracic echocardiography 24 hours pre-catheter then intra-catheter by transesophageal echocardiography and transcatheter angiography.
pressure gradient in mmHg across valve
Time frame: 2 DAYS
pressure gradient in mmHg which are valvular pulmonary stenosis (VPS) pressure gradient in mmHg. pulmonary hypertension measured in mmHg. comparing pre-catheter and intra-catheter procedure measurement measuring by transthoracic echocardiography 24 hours pre-catheter then intra-catheter by transesophageal echocardiography and transcatheter angiography.
2 secondary outcomes
cardiac function by measuring fraction shortening (FS) % in percent
Time frame: 6 months
cardiac function TAPSV in cm/sec
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 22078432van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol. 2011 Nov 15;58(21):2241-7. doi: 10.1016/j.jacc.2011.08.025.
- Background: PubMed 31918898Sachdeva R, Valente AM, Armstrong AK, Cook SC, Han BK, Lopez L, Lui GK, Pickard SS, Powell AJ, Bhave NM, Sachdeva R, Valente AM, Pickard SS, Baffa JM, Banka P, Cohen SB, Glickstein JS, Kanter JP, Kanter RJ, Kim YY, Kipps AK, Latson LA, Lin JP, Parra DA, Rodriguez FH 3rd, Saarel EV, Srivastava S, Stephenson EA, Stout KK, Zaidi AN. ACC/AHA/ASE/HRS/ISACHD/SCAI/SCCT/SCMR/SOPE 2020 Appropriate Use Criteria for Multimodality Imaging During the Follow-Up Care of Patients With Congenital Heart Disease: A Report of the American College of Cardiology Solution Set Oversight Committee and Appropriate Use Criteria Task Force, American Heart Association, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Pediatric Echocardiography. J Am Coll Cardiol. 2020 Feb 18;75(6):657-703. doi: 10.1016/j.jacc.2019.10.002. Epub 2020 Jan 6. No abstract available.
- Background: PubMed 27127554Ramlawi B. The Era of Catheter-Based and Minimally Invasive Cardiac Surgery. Methodist Debakey Cardiovasc J. 2016 Jan-Mar;12(1):3. doi: 10.14797/mdcj-12-1-3. No abstract available.
- Background: PubMed 35654496Turner ME, Bouhout I, Petit CJ, Kalfa D. Transcatheter Closure of Atrial and Ventricular Septal Defects: JACC Focus Seminar. J Am Coll Cardiol. 2022 Jun 7;79(22):2247-2258. doi: 10.1016/j.jacc.2021.08.082.
- Background: PubMed 35455541Divekar AA, Arar YM, Clark S, Tandon A, Zellers TM, Veeram Reddy SR. Transcatheter Device Therapy and the Integration of Advanced Imaging in Congenital Heart Disease. Children (Basel). 2022 Apr 2;9(4):497. doi: 10.3390/children9040497.
- Background: PubMed 35664875Avesani M, Kang SL, Jalal Z, Thambo JB, Iriart X. Renaissance of Cardiac Imaging to Assist Percutaneous Interventions in Congenital Heart Diseases:The Role of Three-Dimensional Echocardiography and Multimodality Imaging. Front Pediatr. 2022 May 19;10:894472. doi: 10.3389/fped.2022.894472. eCollection 2022.
- Background: PubMed 29671282Kenny D. Interventional Cardiology for Congenital Heart Disease. Korean Circ J. 2018 May;48(5):350-364. doi: 10.4070/kcj.2018.0064. Epub 2018 Mar 29.
- Background: PubMed 25574345Maragiannis D, Little SH. Interventional imaging: the role of echocardiography. Methodist Debakey Cardiovasc J. 2014 Jul-Sep;10(3):172-7. doi: 10.14797/mdcj-10-3-172.
- Background: PubMed 37761348Zhang X, Gosnell J, Nainamalai V, Page S, Huang S, Haw M, Peng B, Vettukattil J, Jiang J. Advances in TEE-Centric Intraprocedural Multimodal Image Guidance for Congenital and Structural Heart Disease. Diagnostics (Basel). 2023 Sep 18;13(18):2981. doi: 10.3390/diagnostics13182981.
- Background: PubMed 10159521Ludomirsky A. The use of echocardiography in pediatric interventional cardiac catheterization procedures. J Interv Cardiol. 1995 Oct;8(5):569-78. doi: 10.1111/j.1540-8183.1995.tb00584.x.
- Background: PubMed 36841670Little SH, Rigolin VH, Garcia-Sayan E, Hahn RT, Hung J, Mackensen GB, Mankad S, Quader N, Saric M. Recommendations for Special Competency in Echocardiographic Guidance of Structural Heart Disease Interventions: From the American Society of Echocardiography. J Am Soc Echocardiogr. 2023 Apr;36(4):350-365. doi: 10.1016/j.echo.2023.01.014. Epub 2023 Feb 24.
- Background: PubMed 35634010Broder MS, Gibbs SN, Yermilov I. An Adaptation of the RAND/UCLA Modified Delphi Panel Method in the Time of COVID-19. J Healthc Leadersh. 2022 May 20;14:63-70. doi: 10.2147/JHL.S352500. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography, run by Assiut 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 1 inclusion and 4 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 22 Mar 2024. 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 Asmaa AA Mohamed (00201004493745, Asmaa.Abdelmonem@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
congenital heart defect dimensions in mm, (time frame: 2 DAYS). The study lists 2 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 NCT06324903, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.