AI-Based Analysis of Port Catheter Tip Position

Determination of Port Catheter Tip Position Using Artificial Intelligence-Based Automated Image Analysis

This prospective, single-center observational study will evaluate the performance of an artificial intelligence (AI)-based automated image-analysis method that will be developed, internally tested, and locked before prospective enrollment. The method will estimate the position of totally implantable venous access port catheter tips in adults undergoing right internal jugular vein port implantation as part of routine care. The automated estimate will be compared with a prespecified manual measurement method. Reference measurements of the catheter tip and the cavoatrial junction will be obtained from clinically indicated chest computed tomography images when both structures are visible. No additional chest radiography or computed tomography will be performed for research purposes, and the automated output will not guide catheter placement or alter clinical decisions. The primary performance measure will be the mean absolute error of the automated estimate in the prospective cohort.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Access Devices
• Intervention / Treatment: Diagnostic test: AI-Based Automated Image Analysis; Diagnostic test: Manual A+B Measurement Method

Detailed Description

Before prospective enrollment, a two-dimensional nnU-Net-based multitask model will be developed and internally tested using retrospective chest radiographs from the same center. The model parameters, ensemble, preprocessing steps, and technical output rules will be locked before prospective enrollment. The retrospective development and internal test datasets are not part of the enrollment reported for this record.

The prospective component will include one observational cohort of adults aged 18 years or older undergoing right internal jugular vein port implantation during routine clinical care. Implantation, chest radiography, computed tomography, and all clinical management decisions will remain under the responsibility of the treating clinical team and will not be assigned by the research protocol. The automated output will not be made available for procedural guidance or patient management.

For each evaluable participant, the locked automated method will generate an estimate based on chest radiographic image analysis and a patient-specific Delta adjustment. A prespecified manual A+B measurement method will be applied as a comparator in the same participants. Reference measurements will be derived from the first suitable post-implantation noncontrast chest computed tomography examination obtained for a routine clinical indication, provided that both the catheter tip and the cavoatrial junction are visible and no catheter manipulation occurred beforehand. No additional radiographic or computed tomography examination will be requested for the study.

The primary objective is to quantify the error of the automated estimate using mean absolute error in the prospective cohort. Prespecified secondary analyses will evaluate additional error, agreement, pragmatic accuracy, technical assessability, and repeatability measures. The ±10 mm criterion will be treated as a pragmatic accuracy threshold rather than a clinical safety boundary. The study is a same-center prospective performance evaluation; it is not an external validation and is not designed to assess clinical benefit or to establish that the system is ready for clinical use.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Balamir Utku Seker; Phone Number: +90 539 433 79 62; Email: b.utku.seker@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Bağcılar, Istanbul, Turkey (Türkiye), 34200
      • Bagcilar Training and Research Hospital
      • Contact: Serdar Demirgan; Phone Number: +90 212 440 40 00; Email: istanbuleah30@saglik.gov.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older scheduled for totally implantable venous access port placement through the right internal jugular vein at Bagcilar Training and Research Hospital will be screened consecutively for a single-center prospective observational cohort. Participants will enter the enrolled cohort after written informed consent and confirmation of the participant-level eligibility criteria. Availability and evaluability of a clinically indicated post-implantation noncontrast chest computed tomography examination, absence of documented catheter manipulation or revision before the selected examination, and generation of a valid automated output will define the relevant analysis populations and will not be prerequisites for enrollment. No imaging will be performed solely for research purposes.

Description

Inclusion Criteria:

• Age 18 years or older.
• Planned placement of a totally implantable venous access port through the right internal jugular vein as part of routine clinical care.
• Availability of a suitable pre-implantation chest radiograph obtained as part of routine clinical care.
• Provision of written informed consent.

Exclusion Criteria:

• Age younger than 18 years.
• Cancellation of the routine clinical port implantation plan.
• Planned or performed port placement through a venous access route other than the right internal jugular vein.
• No suitable pre-implantation chest radiograph available for study assessment.
• Advanced thoracic deformity or mediastinal distortion precluding the required study measurements.
• Inability or unwillingness to provide written informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Prospective Port Catheter Cohort; Adults aged 18 years or older undergoing totally implantable venous access port implantation through the right internal jugular vein as part of routine clinical care will be enrolled in a single prospective observational cohort. In each evaluable participant, the locked AI-based automated A+B+Delta method and the prespecified manual A+B measurement method will be assessed using reference measurements from clinically indicated post-implantation noncontrast chest computed tomography. No research-specific imaging will be performed, and the automated output will not guide port implantation or alter clinical decisions.

Diagnostic test: AI-Based Automated Image Analysis; The locked automated method will use chest radiographic image analysis and a patient-specific Delta adjustment to estimate port catheter tip position. The method will be evaluated offline using reference measurements derived from clinically indicated post-implantation noncontrast chest computed tomography. Its output will not be provided to the clinical team and will not guide port implantation or alter clinical decisions.; Diagnostic test: Manual A+B Measurement Method; The prespecified manual A+B method will estimate port catheter tip position using surface and chest radiographic measurements. It will be applied as a comparator in the same participants. The manual research measurement will not guide port implantation or alter clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method	Mean absolute error (MAE), in millimeters, will be calculated as the arithmetic mean of the absolute differences between the catheter advancement length estimated by the locked AI-based automated A+B+Delta method and the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The analysis population will include participants with both a valid automated output and an evaluable reference measurement. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using 10,000 participant-level bias-corrected and accelerated bootstrap resamples.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method	Median absolute error (MedAE), in millimeters, will be calculated as the median of the absolute differences between the catheter advancement length estimated by the locked AI-based automated A+B+Delta method and the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The analysis population will include participants with both a valid automated output and an evaluable reference measurement. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Root Mean Squared Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method	Root mean squared error (RMSE), in millimeters, will be calculated as the square root of the arithmetic mean of the squared differences between the catheter advancement length estimated by the locked AI-based automated A+B+Delta method and the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The analysis population will include participants with both a valid automated output and an evaluable reference measurement. Lower values indicate smaller overall estimation error, and larger individual errors have greater influence because differences are squared before averaging. A 95% confidence interval will be estimated using participant-level bootstrap resampling.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Signed Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method	Mean signed error, in millimeters, will be calculated as the arithmetic mean of the catheter advancement length estimated by the locked AI-based automated A+B+Delta method minus the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The analysis population will include participants with both a valid automated output and an evaluable reference measurement. Positive values indicate that the automated method estimates a longer advancement length than the reference, negative values indicate a shorter estimate, and zero indicates no average directional error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Paired Difference in Absolute Error Between the AI-Based Automated A+B+Delta and Manual A+B Methods	For each participant, absolute error will be calculated for both the locked AI-based automated A+B+Delta method and the manual A+B method relative to the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The paired difference, in millimeters, will be calculated as automated absolute error minus manual absolute error, and its arithmetic mean will be reported. The analysis population will include participants with an evaluable reference measurement and valid estimates from both methods. Negative values indicate a smaller absolute error for the automated method, positive values indicate a smaller absolute error for the manual method, and zero indicates no average paired difference. A 95% confidence interval will be estimated using participant-level bootstrap resampling.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Proportion of AI-Based Automated A+B+Delta Estimates With Absolute Error Within 10 mm	The proportion of evaluable participants whose absolute error is 10 mm or less will be calculated for the locked AI-based automated A+B+Delta method. Absolute error will be defined as the absolute difference between the automated estimate and the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The denominator will include participants with both a valid automated output and an evaluable reference measurement, and the result will be reported as a percentage with a 95% Wilson score confidence interval. A higher percentage indicates that a larger proportion of estimates meet this prespecified pragmatic accuracy criterion. The 10 mm threshold is an operational technical accuracy criterion and not a clinical safety boundary.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Paired Difference in Proportions of Estimates With Absolute Error Within 10 mm Between the AI-Based Automated A+B+Delta and Manual A+B Methods	For each participant, the locked AI-based automated A+B+Delta estimate and the manual A+B estimate will each be classified by whether the absolute error from the reference catheter advancement length is 10 mm or less. The paired proportion difference, in percentage points, will be calculated as the automated qualifying proportion minus the manual qualifying proportion. The analysis population will include participants with an evaluable reference measurement and valid estimates from both methods. Positive values indicate a higher qualifying proportion for the automated method, and negative values indicate a higher qualifying proportion for the manual method. A 95% confidence interval will be calculated using Newcombe's method 10; an exact two-sided McNemar test will be used as an auxiliary analysis. The 10 mm threshold is a prespecified pragmatic accuracy criterion and not a clinical safety boundary.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Technical Success Rate of the AI-Based Automated A+B+Delta Method	Technical success will be defined as the generation of a valid numerical output by the AI-based automated A+B+Delta method after the method has been locked for prospective evaluation. The numerator will be the number of participants enrolled in the prospective cohort for whom the method generates a valid automated output, and the denominator will be all participants enrolled in the prospective cohort. A valid output requires the prespecified image-scale, anatomical-landmark, projection, image-quality, and uncertainty criteria to be satisfied. The result will be reported as a percentage with a 95% Wilson score confidence interval. Technical success will be reported separately from measurement accuracy among participants with evaluable reference data. A higher percentage indicates greater technical output availability and does not represent clinical effectiveness or safety.	At baseline, during offline analysis of the pre-implantation chest radiograph obtained before port implantation
Intraobserver Agreement of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance Assessed by ICC(A,1)	Intraobserver agreement of the computed tomography (CT)-derived catheter tip-to-cavoatrial junction distance (dBT) will be assessed using a two-way random-effects, absolute-agreement, single-measure intraclass correlation coefficient [ICC(A,1)]. The same radiologist will repeat the dBT measurement in a prespecified random subset of 60 cases after a 4-week washout period, using newly assigned identifiers and reshuffled images while blinded to the initial measurement. Only cases evaluable at both readings will be analyzed. Higher ICC values indicate greater relative agreement. The estimate will be reported with a 95% confidence interval.	At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Mean Intraobserver Difference in the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance	The mean signed difference (second reading minus first reading), in millimeters, will be calculated for the computed tomography-derived catheter tip-to-cavoatrial junction distance in the prespecified random subset of 60 cases measured twice by the same radiologist after a 4-week washout period. The radiologist will use newly assigned identifiers and reshuffled images and will be blinded to the initial measurement. Only cases evaluable at both readings will be analyzed. Positive values indicate a larger measurement at the second reading, negative values indicate a smaller measurement, and values closer to zero indicate less average systematic difference. A 95% confidence interval will be reported.	At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Within-Subject Standard Deviation of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance	Within-subject standard deviation (wSD), in millimeters, will quantify within-observer variation in the computed tomography-derived catheter tip-to-cavoatrial junction distance. In the prespecified random subset of 60 cases, the same radiologist will repeat the measurement after a 4-week washout period using newly assigned identifiers and reshuffled images while blinded to the initial measurement. Only cases evaluable at both readings will be analyzed. For these cases, wSD will be calculated as the standard deviation of the paired differences (second reading minus first reading) divided by the square root of 2. Lower values indicate less within-observer measurement variation. A chi-square-based 95% confidence interval will be reported.	At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Bland-Altman Limits of Agreement for the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance	Bland-Altman limits of agreement (LoA), in millimeters, will be calculated for the CT-derived catheter tip-to-cavoatrial junction distance in a prespecified random subset of 60 cases measured twice by the same radiologist after a 4-week washout period. Paired differences will be defined as the second reading minus the first. The mean paired difference and lower and upper LoA, calculated as the mean difference minus and plus 1.96 times the standard deviation of paired differences, will be reported. Only cases evaluable at both readings will be analyzed. The radiologist will use newly assigned identifiers and reshuffled images and will be blinded to the initial measurement. A 95% confidence interval for the mean difference will be calculated using the t distribution; 95% confidence intervals for the lower and upper LoA will be obtained using an exact two-sided tolerance-factor method. Narrower limits indicate less within-observer measurement variation.	At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Repeatability Coefficient of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance	The repeatability coefficient (RC), in millimeters, will quantify within-observer repeatability of the computed tomography-derived catheter tip-to-cavoatrial junction distance in the prespecified random subset of 60 cases measured twice by the same radiologist after a 4-week washout period. Paired differences will be defined as the second reading minus the first reading. The RC will be calculated as 1.96 times the standard deviation of the paired differences. Only cases evaluable at both readings will be analyzed. The radiologist will use newly assigned identifiers and reshuffled images and will be blinded to the initial measurement. Lower RC values indicate less within-observer measurement variation. A chi-square-based 95% confidence interval will be reported.	At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Bland-Altman Limits of Agreement Between the AI-Based Automated A+B+Delta Estimate and the CT-Derived Reference	For participants with a valid automated output and an evaluable CT-derived reference measurement, the paired difference, in millimeters, will be defined as the catheter advancement length estimated by the locked AI-based automated A+B+Delta method minus the CT-derived reference catheter advancement length. The mean difference and the lower and upper 95% limits of agreement will be calculated as the mean difference minus and plus 1.96 times the standard deviation of the paired differences. A 95% confidence interval for the mean difference will be calculated using the t distribution; 95% confidence intervals for the lower and upper limits will be obtained using an exact two-sided tolerance-factor method. Positive differences indicate longer automated estimates than the reference, and negative differences indicate shorter automated estimates. The analysis describes agreement and does not establish clinical interchangeability or safety.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Absolute Error of Catheter Advancement Length Estimated by the Manual A+B Method	Mean absolute error (MAE), in millimeters, will be calculated as the arithmetic mean of the absolute differences between the catheter advancement length estimated by the prespecified manual A+B measurement method and the CT-derived reference catheter advancement length. The analysis population will include participants with both a valid manual A+B estimate and an evaluable CT-derived reference measurement. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Median Absolute Error of Catheter Advancement Length Estimated by the Manual A+B Method	Median absolute error (MedAE), in millimeters, will be calculated as the median of the absolute differences between the catheter advancement length estimated by the prespecified manual A+B measurement method and the CT-derived reference catheter advancement length. The analysis population will include participants with both a valid manual A+B estimate and an evaluable CT-derived reference measurement. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Root Mean Squared Error of Catheter Advancement Length Estimated by the Manual A+B Method	Root mean squared error (RMSE), in millimeters, will be calculated as the square root of the arithmetic mean of the squared differences between the catheter advancement length estimated by the prespecified manual A+B measurement method and the CT-derived reference catheter advancement length. The analysis population will include participants with both a valid manual A+B estimate and an evaluable CT-derived reference measurement. Lower values indicate smaller overall estimation error, and larger individual errors have greater influence because differences are squared before averaging. A 95% confidence interval will be estimated using participant-level bootstrap resampling.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Signed Error of Catheter Advancement Length Estimated by the Manual A+B Method	Mean signed error, in millimeters, will be calculated as the arithmetic mean of the catheter advancement length estimated by the prespecified manual A+B measurement method minus the CT-derived reference catheter advancement length. The analysis population will include participants with both a valid manual A+B estimate and an evaluable CT-derived reference measurement. Positive values indicate that the manual method estimates a longer advancement length than the reference, negative values indicate a shorter estimate, and zero indicates no average directional error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Bland-Altman Limits of Agreement Between the Manual A+B Estimate and the CT-Derived Reference	For participants with a valid manual A+B estimate and an evaluable CT-derived reference measurement, the paired difference, in millimeters, will be defined as the catheter advancement length estimated by the prespecified manual A+B method minus the CT-derived reference catheter advancement length. The mean difference and the lower and upper 95% limits of agreement will be calculated as the mean difference minus and plus 1.96 times the standard deviation of the paired differences. A 95% confidence interval for the mean difference will be calculated using the t distribution; 95% confidence intervals for the lower and upper limits will be obtained using an exact two-sided tolerance-factor method. Positive differences indicate longer manual estimates than the reference, and negative differences indicate shorter manual estimates. The analysis describes agreement and does not establish clinical interchangeability or safety.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Absolute Error of the AI-Based Automated A+B+Delta Method Within 24 Hours After Port Implantation and Before Catheter Manipulation	In the prespecified sensitivity subset of participants whose first eligible post-implantation noncontrast chest computed tomography examination is obtained within 24 hours after port implantation and before any documented catheter manipulation, mean absolute error (MAE), in millimeters, will be calculated as the arithmetic mean of the absolute differences between the catheter advancement length estimated by the locked AI-based automated A+B+Delta method and the CT-derived reference catheter advancement length. Only participants with a valid automated output and an evaluable CT-derived reference measurement will be included. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.	Within 24 hours after port implantation and before any documented catheter manipulation, at the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care
Proportion of AI-Based Automated A+B+Delta Estimates With Absolute Error Within 10 mm Within 24 Hours After Port Implantation and Before Catheter Manipulation	In the prespecified sensitivity subset of participants whose first eligible post-implantation noncontrast chest computed tomography examination is obtained within 24 hours after port implantation and before any documented catheter manipulation, the proportion of evaluable participants whose absolute error is 10 mm or less will be calculated for the locked AI-based automated A+B+Delta method. Absolute error will be defined as the absolute difference between the automated estimate and the CT-derived reference catheter advancement length. The denominator will include participants with both a valid automated output and an evaluable CT-derived reference measurement. The result will be reported as a percentage with a 95% Wilson score confidence interval. The 10 mm threshold is a prespecified pragmatic technical accuracy criterion and not a clinical safety boundary.	Within 24 hours after port implantation and before any documented catheter manipulation, at the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Huber Regression Slope for the Association Between the Port Implantation-to-CT Interval and Signed Error	In this prespecified exploratory analysis, the association between the interval from port implantation to the first eligible post-implantation noncontrast chest computed tomography examination and the signed error of the locked AI-based automated A+B+Delta method will be assessed among participants with a valid automated output and an evaluable CT-derived reference measurement. Signed error, in millimeters, will be defined as the automated catheter advancement length estimate minus the CT-derived reference length. The interval, recorded in hours, will be transformed as log2(1 + hours). A robust Huber regression slope with a two-sided 95% confidence interval will be reported; Spearman's rank correlation coefficient with a two-sided 95% confidence interval will be an auxiliary analysis. Raw and Holm-adjusted Spearman p-values will be reported. The slope is expressed in millimeters per log2(1 + hours); positive values indicate increasingly positive signed error with longer intervals.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Huber Regression Slope for the Association Between the Port Implantation-to-CT Interval and Absolute Error	In this prespecified exploratory analysis, the association between the interval from port implantation to the first eligible post-implantation noncontrast chest computed tomography examination and the absolute error of the locked AI-based automated A+B+Delta method will be assessed among participants with a valid automated output and an evaluable CT-derived reference measurement. Absolute error, in millimeters, will be defined as the absolute difference between the automated catheter advancement length estimate and the CT-derived reference length. The interval, recorded in hours, will be transformed as log2(1 + hours). A robust Huber regression slope with a two-sided 95% confidence interval will be reported; Spearman's rank correlation coefficient with a two-sided 95% confidence interval will be an auxiliary analysis. Raw and Holm-adjusted p-values will be reported for the Spearman test. Slope is in millimeters per log2(1 + hours); positive values indicate increasing absolute error.	At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision

Collaborators and Investigators

• Sponsor: Bagcilar Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: August 27, 2026
• First Posted (Actual): August 28, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Deep Learning; Computed Tomography; Port Catheter; Chest Radiography; Cavoatrial Junction
• Other Study ID Numbers: E-10840098-50.04-1975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The plan to share de-identified individual participant data has not yet been finalized. Any future sharing decision will be subject to applicable ethics approval, participant consent, institutional policy, and data protection requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No