IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes (IDEAL)

October 1, 2025 updated by: Zhang longjiang,MD, Jinling Hospital, China

Assessing the Impact of an Artificial Intelligence-Based Model for Intracranial Aneurysm Detection in CT Angiography on Patients' Diagnosis and Outcomes: The IDEAL Study - A Web-Based Multicenter, Double-Blinded Randomized Controlled Trial

This study (IEDAL study) intends to prospectively enroll more than 6450 patients who will undergo head CT angiography (CTA) scanning in the outpatient clinic. It will be carried out in 21 hospitals in more than 10 provinces in China. The patient's head CTA images will be randomly assigned to the True-AI and Sham-AI group with a ratio of 1:1, and the patients and radiologists are unaware of the allocation. The primary outcomes are sensitivity and specificity of detecting intracranial aneurysms. The secondary outcomes focus on the prognosis and outcomes of the patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A multicenter, prospective, double-blind, randomized controlled trial will be conducted (IDEAL study). Patients who are scheduled to undergo cranial CT angiography (CTA) scanning will be randomly divided into two groups with a ratio of 1:1, one of the group will be assigned to True-AI aided intracranial aneurysms diagnosis strategy (True-AI group) and the other will be assigned to Sham-AI aided intracranial aneurysms diagnosis strategy (Sham-AI group, which has a sensitivity close to 0% and a similar specificity to True-AI). The primary outcomes are diagnostic sensitivity and specificity of detecting aneurysms. Secondary endpoints include other diagnostic performance indexes for intracranial aneurysms; diagnostic performances for other intracranial lesions for intracranial arterial stenosis, occlusion, and intracranial tumors; detection rates of intracranial lesions according to Radiology Reports; workload of head CTA interpretation; resource use; treatment-related indexes during patient follow-up (e.g. clinical follow-up, hospitalization, rate of patients undergoing DSA); life quality; outcomes of aneurysm-related events; repeat head CTA or MRA at 12-month follow; cost-effectiveness analysis between intervention and control arm to evaluate the short- and longterm influence of AI system to the routine practice and patients' prognosis and outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Haikou, China
        • Recruiting
        • Hainan General Hospital
        • Contact:
      • Kashgar, China
        • Recruiting
        • The First People's Hospital of Kashgar Region
        • Contact:
      • Lanzhou, China
        • Recruiting
        • University Second Hospital
        • Contact:
      • Lianyungang, China
        • Recruiting
        • First People's Hospital of Lianyungang
        • Contact:
      • Ma’anshan, China
        • Recruiting
        • Ma'anshan People's Hospital
        • Contact:
      • Nanjing, China
        • Recruiting
        • BenQ Medical Center, Affiliated BenQ Hospital of Medical School, Nanjing Medical University
        • Contact:
      • Shenzhen, China
        • Recruiting
        • Long Gang Central Hospital of Shenzhen
        • Contact:
      • Suqian, China
        • Recruiting
        • The Affiliated Suqian First Hospital of Nanjing Medical University
        • Contact:
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Yinchuan, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of University of Science and Technology of China
        • Contact:
      • Wuhu, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Wannan Medical College
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Shiyan, Hubei, China
        • Recruiting
        • Shiyan People's Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210018
        • Recruiting
        • Research Institute Of Medical Imaging Jinling Hospital
        • Contact:
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
      • Weifang, Shandong, China
        • Recruiting
        • Yidu Central Hospital Affiliated to Shandong Second Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult inpatients and outpatients who are scheduled for head CTA scanning.

Exclusion Criteria:

  • Age under 18 years.
  • Patients with contraindications to CTA.
  • Modified Rankin Scale (mRS) score > 3.
  • Refuse to sign informed consent.
  • Participation in other clinical studies of intracranial aneurysms.
  • Patients with failed head CTA scanning or incomplete image data, or poor image quality.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: True-AI-integrated intracranial aneurysms diagnosis strategy
For patients who underwent head CTA and assigned to True-AI group, they will be diagnosed by a radiologist who are aided by the True-AI-integrated intracranial aneurysms diagnosis strategy.
Device: True-AI-integrated intracranial aneurysms diagnosis strategy
The True-AI deep-learning based model for intracranial aneurysms detection had a patient-wise sensitivity, lesion-wise sensitivity and specificity of 0.96, 0.87, and 0.80 in the internal validation dataset.
Sham Comparator: Sham-AI-integrated intracranial aneurysms diagnosis strategy
For patients who underwent head CTA and assigned to Sham-AI group, they will be diagnosed by a radiologist who are aided by the Sham-AI-integrated intracranial aneurysms diagnosis strategy. To mimic the True-AI, the Sham-AI had a sensitivity close to 0% and a similar specificity to the True-AI.
Device: Sham-AI-integrated intracranial aneurysms diagnosis strategy
The Sham-AI deep-learning based model for intracranial aneurysms detection is designed to have a sensitivity close to 0% and a similar specificity to the True-AI. In the internal validation dataset, the Sham-AI had a patient-wise sensitivity, lesion-wise sensitivity, specificity of 0.02, 0.01, and 0.80, respectively.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To compare diagnostic sensitivity of intracrnial aneurysms between intervention and control arm.
Time Frame: 6 months.
The proportion of examinations in which at least one aneurysm is discovered and indicated among groundtruth aneurysms.
6 months.
To compare diagnostic specificity of intracrnial aneurysms between intervention and control arm.
Time Frame: 6 months.
The proportion of examinations in which no aneurysms are spotted by the reader among groundtruth non-aneurysms.
6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To compare other diagnostic performances for intracranial aneurysms between intervention and control arm.
Time Frame: 6 months.
To compare accuracy, lesion-wise sensitivity, positive predictive value and negative predictive value for intracranial aneurysms between intervention and control arm.
6 months.
To compare diagnostic performances for other intracranial lesions between intervention and control arm.
Time Frame: 6 months.
The sensitivity, specificity, accuracy, positive predictive value and negative predictive value for intracranial arterial stenosis, occlusion, and intracranial tumors are compared between intervention and control arm.
6 months.
To compare detection rates of intracranial lesions according to Radiology Reports between intervention and control arm.
Time Frame: 6 months.
Detection rates of intracranial aneurysms, intracranial arterial stenosis, occlusion, and intracranial tumors according to Radiology Reports are compared between intervention and control arm.
6 months.
To assess the workload of head CT angiography interpretation.
Time Frame: 6 months.
Time of interpreting head CT angiography images, number of consensus meeting are compared between intervention and control arm.
6 months.
To assess resource use.
Time Frame: At 3-month and 12-month follow-up.
The number of care encounters (in-person) during follow-up, total number of outpatient encounters for aneurysm referral, total number of cerebral artery disease testing are compared between intervention and control arm.
At 3-month and 12-month follow-up.
Rate of patients of subsequent hospitalization during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Rate of patients of subsequent hospitalization is compared between intervention and control arm.
At 3-month and 12-month follow-up.
In-hospital mortality rate during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
In-hospital mortality rate is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Morbidity (modified Rankin Score ≥ 3) from intracranial haemorrhage or treatment during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Morbidity (modified Rankin Score ≥ 3) from intracranial haemorrhage or treatment is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Length of hospital stay during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Length of hospital stay is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Rate of hospitalization for intracranial aneurysms during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Rate of hospitalization for intracranial aneurysms is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Rate of patients undergoing digital subtraction angiography (DSA) during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Rate of patients undergoing digital subtraction angiography (DSA) is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Detection rate of intracranial aneurysms among digital subtraction angiographys (DSA) during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Detection rate of intracranial aneurysms among digital subtraction angiographys (DSA) is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Detection rate of no abnormality among digital subtraction angiographys (DSA) during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Detection rate of no abnormality among digital subtraction angiographys (DSA) is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Distribution of the methods for aneurysms management (conservative/coil/clip/others) during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Distribution of the methods for aneurysms management (conservative/coil/clip/others) is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Rates of aneurysm treatment related complications during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Rate of aneurysm treatment related complications (intraoperative rupture, stroke, et al) is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Rate of recurrence or residual of intracranial aneurysm after surgery during patient follow-up.
Time Frame: At 12-month follow-up.
Rate of recurrence or residual of intracranial aneurysm after surgery is compared between intervention and control arm.
At 12-month follow-up.
Life quality assessed by EuroQol 5-Dimensional, 5-Level (EQ-5D-5L) during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Life quality assessed by EuroQol 5-Dimensional, 5-Level (EQ-5D-5L) scores are compared between intervention and control arm, which ranges from 5 to 25, and higher scores mean a worse outcome.
At 3-month and 12-month follow-up.
Restrictions in daily activities assessed by Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) scores during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Restrictions in daily activities assessed by Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) scores are compared between intervention and control arm.
At 3-month and 12-month follow-up.
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) is compared between intervention and control arm, which ranges from 0 to 21, and higher scores mean a worse outcome.
At 3-month and 12-month follow-up.
Depression Screening assessed by Patient Health Questionnaire-9 (PHQ-9) scores during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Depression Screening assessed by Patient Health Questionnaire-9 (PHQ-9) scores are compared between intervention and control arm, which ranges from 0 to 27, and higher scores mean a worse outcome.
At 3-month and 12-month follow-up.
Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) scores during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) scores are compared between intervention and control arm, which ranges from 0 to 21, and higher scores mean a worse outcome.
At 3-month and 12-month follow-up.
General health assessed by Short-Form 36 Health Survey (SF-36) scores during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
General health assessed by Short-Form 36 Health Survey (SF-36) scores are compared between intervention and control arm.
At 3-month and 12-month follow-up.
Functional outcome assessed by Modified Rankin Scale (mRS) scores during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Functional outcome assessed by Modified Rankin Scale (mRS) scores are compared between intervention and control arm, which ranges from 0 to 5, and higher scores mean a worse outcome.
At 3-month and 12-month follow-up.
All-cause mortality during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
All-cause mortality is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Rate of aneurysm growth during patient follow-up.
Time Frame: At 12-month follow-up.
Rate of aneurysm growth is compared between intervention and control arm.
At 12-month follow-up.
Rate of aneurysm rupture during patient follow-up.
Time Frame: At 12-month follow-up.
Rate of aneurysm rupture is compared between intervention and control arm.
At 12-month follow-up.
Rate of subarachnoid hemorrhage (SAH) during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Rate of subarachnoid hemorrhage (SAH) is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Rate of other types of stroke (hemorrhagic stroke, ischemic stroke) during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Rate of other types of stroke (hemorrhagic stroke, ischemic stroke) is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Mortality of aneurysms-rupture during patient follow-up.
Time Frame: At 3-month and 12-month follow-up.
Mortality of aneurysms-rupture is compared between intervention and control arm.
At 3-month and 12-month follow-up.
Morphological change by head CTA or magnetic resonance angiography at the 12-month follow-up.
Time Frame: At 12-month follow-up.
Morphological change by head CTA or magnetic resonance angiography is assessed.
At 12-month follow-up.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-wise sensitivity and specificity at different centers, provinces, geography areas and levels of physician.
Time Frame: 6 months.
To compare diagnostic performances of patient-wise sensitivity and specificity for intracranial aneurysms between intervention and control arm in subgroups of different centers, provinces, geography areas and physician level.
6 months.
Subgroup analysis of different size (< 5 mm vs. ≥ 5 mm), locations of intracranial aneurysms.
Time Frame: 6 months.
To compare diagnostic performances for intracranial aneurysms between intervention and control arm in subgroups of different size (internal carotid artery vs. middle cerebral artery vs. anterior cerebral artery vs. posterior communication artery vs. anterior communication artery vs. vertebral basilar artery vs. others), locations (internal carotid artery vs. middle cerebral artery vs. anterior cerebral artery vs. posterior communication artery vs. anterior communication artery vs. vertebral basilar artery vs. others) of intracranial aneurysms.
6 months.
Subgroup analysis of different gender (male vs. female), age (≤ 54 years or. >54 years), subarachnoid hemorrhage status (with vs. without SAH) of patients
Time Frame: 6 months.
To compare diagnostic performances for intracranial aneurysms between intervention and control arm in subgroups of different gender (male vs. female), age (≤ 54 years or. >54 years), subarachnoid hemorrhage status (with vs. without SAH) of patients.
6 months.
Patient-wise sensitivity and specificity for patients with previous head digital subtraction angiography or surgery or not.
Time Frame: 6 months.
To compare diagnostic performances of patient-wise sensitivity and specificity for intracranial aneurysms between intervention and control arm in subgroups of patients with previous head angiography or surgery or not.
6 months.
Patient-wise sensitivity and specificity for patients with subsequent head digital subtraction angiography or surgery or not.
Time Frame: 6 months.
To compare diagnostic performances of patient-wise sensitivity and specificity for intracranial aneurysms between intervention and control arm in subgroups of patients with subsequent head angiography or surgery or not.
6 months.
Ethical safety outcomes.
Time Frame: 6 months.
The monthly reported detection rates of intracranial aneurysms, tumors, stenosis, and occlusive are calculated and compared with the reported detection rates in the previous 3 months during the trial.
6 months.
Learning curve of AI-augmented intracranial aneurysm diagnosis.
Time Frame: 6 months.
Dynamic changes in sensitivity and specificity of aneurysm diagnosis from the first 7-days through to the last 7-days of all center trials.
6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jinling Hospital, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Trial Manager, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022NZKY-015-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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