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No Specific ConditionsNCT06281938

Machine Learning and 3D Image-based Modeling for Body Weight Estimation.

A study testing Weight estimation using 3D camera in people with No Specific Conditions and Weight, Body, run by Florida Atlantic University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this randomized controlled clinical trial is to [learn about, test, compare etc.] in critically ill or injured cohorts of patients presenting to the Emergency Department. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
No Specific Conditions, Weight, Body, Drug Dose
What is being tested?
Weight estimation using 3D camera
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
No sites listed yet
Study dates
Jun 2026to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any patient presenting to the Emergency Department of the study site, who will require any form of weight-based intravenous drug therapy, and who will be admitted to the hospital.

Who cannot join

  • Patients who are unable to provide consent.
  • Patients whose medical treatment could be negatively impacted by participation in the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Richard Shih, MD contact

561 297 3000

rshih@health.fau.edu

About this study

Official title: Machine Learning and 3D Image-based Modeling for Real-time Body Weight and Body Composition Estimation During Emergency Medical Care.

The goal of this randomized controlled clinical trial is to [learn about, test, compare etc.] in critically ill or injured cohorts of patients presenting to the Emergency Department. The main question[s] it aims to answer are:

  • Are weight estimates from a 3D camera system more accurate than standard methods of weight estimation?
  • Do patients who receive weight estimates with a 3D camera system have fewer drug dosing errors than patients receiving standard care?
Read more

Participants will either receive a weight estimate using a 3D camera system, or standard methods of care.

Researchers will compare the 3D camera group to those with standard care to see if the weight estimates are more accurate, to see if drug dosing is more accurate, and to compare the incidence of adverse events related to medications in each group.

Read the detailed description

Drug dosing errors can have a catastrophic effect in acutely ill patients such as stroke patients needing thrombolytic therapy or patients requiring urgent sedation. In an acutely ill patient, inaccurate weight estimates are a significant cause of dosing errors, and weight estimates that deviate by >10% from actual weight could make treatment itself life threatening. Inaccurate weight estimates lead to inaccurate drug doses, which can result in potentially fatal treatment failure (from subtherapeutic doses) or potentially fatal adverse events (from supratherapeutic doses). Nearly 75% of treatment failures in obese patients may be related to errors in weight estimation. When clinical care is time-sensitive, it may be impossible to obtain a measured weight in >50% of patients. In these circumstances, a rapid, accurate method for estimating weight is critical. One recent innovation is the use of a low-cost 3D camera system to estimate weight. The 3D camera device (e.g., Intel RealSense D415) is used to obtain a point cloud map of the patient's body, from which a weight estimate can be estimated based on algorithms derived using convoluted neural network analysis. Initial studies have been extremely promising in terms of the accuracy achievable by this system in estimating Total Body Weight (TBW).

The primary aim of this study is to measure the accuracy of weight estimations by the 3D camera system in acutely ill or injured ED patients and compare this accuracy against that of standard care. The researchers will compare the performance and downstream effects of weight estimation using the 3D camera system against standard care in a randomized controlled trial of acutely ill or injured adults presenting to the ED.

The key hypothesis is that the 3D camera system will provide real-time estimates of TBW, IBW and LBW in an emergency setting and will exceed the accuracy of existing methods of weight estimation.

Supporting non-clinical trial studies will establish the accuracy of the 3D camera system in laboratory conditions, and in simulated medical emergencies. However, its performance, and its impact on downstream drug dosing accuracy, needs to be established during emergency care in a real clinical setting. This study will provide an essential perspective about the accuracy and functioning of the 3D camera system as well as real-world weight estimation during emergency care. It will also describe the ability to measure weight using in-bed scales and to obtain weight estimations from patients themselves and family members in ED patients. The secondary objective, to determine the accuracy of drug doses in each arm of the study, will provide critical information on the need for alternative weight scalars in obese and morbidly obese patients presenting to the ED. The study will establish the need for standards and policies to guide dose scaling in obese patients in the ED. Information on the actual usage of drugs that should be scaled to TBW and those that should be scaled to LBW will provide useful real-world insight into the magnitude of the problem in the threat to patient safety by using a "one size fits all" approach to drug dose calculations for all patients, irrespective of weight status.

Acutely ill patients presenting to the ED of a large regional hospital, and who require weight-based drug therapy, will be enrolled in the study. They will be randomised to either receive a weight estimation using a 3D camera system (which will provide estimates of TBW, IBW and LBW), or to receive standard care. All other interventions and medical care will be standard care.

These patients will be followed for the first 72 hours of their hospital stay. The accuracy of the weight estimates will be compared between the groups, as will the drug dose accuracy, and any adverse events related to drug therapy.

Being tested
Weight estimation using 3D camera, Standard care weight estimation
Keywords
weight estimation, drug dosing, 3D camera, total body weight, lean body weight, ideal body weight
Medical subject headings
Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight estimation using 3D cameraOther

    Total body weight, ideal body weight and lean body weight estimates will be obtained using a 3D camera system. This weight will be used for calculation of weight-based drug doses and other weight-based interventions.

  • Standard care weight estimationOther

    Standard care (unspecified) will be used to determine weight-based dosing and other management.

Study groups in NCT06281938
Study groupRoleWhat they receive
3D camera weight estimationExperimentalTBW, LBW and IBW will be automatically estimated using the 3D camera system. All relevant medical care will be based on this weight for the first 72 hours
Receives: Other: Weight estimation using 3D camera
Standard care weight estimationPlacebo comparatorTBW, LBW and IBW will be estimated using standard care processes. All relevant medical care will be based on this weight for the first 72 hours
Receives: Other: Standard care weight estimation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight estimation accuracy

    Determination of accuracy against reference standard

    Measured: Immediate

  2. Time to obtain weight estimate

    Determination of time taken to obtain weight estimate

    Measured: Immediate

  3. Drug dosing accuracy

    Determination of accuracy against reference standard

    Measured: First 72 hours

  4. Correct dosing scalar used

    Determination of accuracy against reference standard

    Measured: First 72 hours

Secondary outcomes (1)
  1. Accuracy of in-bed scales

    Determination of accuracy against reference standard

    Measured: Immediate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention cohort and control cohort will be used
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06281938
Sponsor's protocol ID
1617209
Status last verified
Jun 2025
First submitted
21 Feb 2024
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data generated during this project will be shared in multiple different forums. Data will be shared locally at Florida Atlantic University through presentations. Results will be made available to the broader scientific community through publications and presentations at national and international meetings. Protocols and/or method(s) developed during the proposed study will be made readily available for educational, research, and non-profit purposes, provided that a data-sharing agreement is signed. Any other important techniques developed from this work will be made available electronically for all non-business purposes described above. The intended date for such availability will be less than 6 months after the fulfillment of the Specific Aims of this proposal. In addition, a dataset containing non-identifiable point cloud data and images, along with ground truth weight data, will be stored in a repository that can be accessed through a data-sharing agreement.

Questions about this trial

What is this clinical trial studying?

A study testing Weight estimation using 3D camera in people with No Specific Conditions and Weight, Body, run by Florida Atlantic 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 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: opening soon, as of the sponsor's last update on 6 Jun 2025. 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. Some participants in this study may receive a placebo. 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 Richard Shih, MD (561 297 3000, rshih@health.fau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight estimation accuracy (time frame: Immediate). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Jun 2025.

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