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.
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.
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.
- Conditions
- No Specific Conditions, Weight, Body, Drug Dose, Weight-Estimation
- 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 group | Role | What they receive |
|---|---|---|
| 3D camera weight estimation | Experimental | TBW, 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 estimation | Placebo comparator | TBW, 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.
Weight estimation accuracy
Determination of accuracy against reference standard
Measured: Immediate
Time to obtain weight estimate
Determination of time taken to obtain weight estimate
Measured: Immediate
Drug dosing accuracy
Determination of accuracy against reference standard
Measured: First 72 hours
Correct dosing scalar used
Determination of accuracy against reference standard
Measured: First 72 hours
Secondary outcomes (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.
- First posted28 Feb 2024
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Specific ConditionsStudies of the same condition, open and under way.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mike Wells, MD, PhD, Study director, Research Professor
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning and 3D Image-based Modeling for Real-time Body Weight and Body Composition Estimation During Emergency Medical Care.
- ClinicalTrials.gov ID
- NCT06281938
- Acronym / sponsor ID
- 1617209
- Conditions
- No Specific Conditions, Weight, Body, Drug Dose, Weight-Estimation
- Keywords
- weight estimation, drug dosing, 3D camera, total body weight, lean body weight, ideal body weight
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Feb 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.
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?
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention cohort and control cohort will be used
| Arm | Type | Receives |
|---|---|---|
| 3D camera weight estimation | Experimental | Other: Weight estimation using 3D cameraTBW, 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 |
| Standard care weight estimation | Placebo comparator | Other: Standard care weight estimationTBW, 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who are unable to provide consent.
- Patients whose medical treatment could be negatively impacted by participation in the study.
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 |
|---|---|---|
| Weight estimation using 3D cameraTotal 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. | Other | 3D camera weight estimation |
| Standard care weight estimationStandard care (unspecified) will be used to determine weight-based dosing and other management. | Other | Standard care weight estimation |
Primary outcome
Weight estimation accuracy
Time frame: Immediate
Determination of accuracy against reference standard
Time to obtain weight estimate
Time frame: Immediate
Determination of time taken to obtain weight estimate
Drug dosing accuracy
Time frame: First 72 hours
Determination of accuracy against reference standard
Correct dosing scalar used
Time frame: First 72 hours
Determination of accuracy against reference standard
1 secondary outcome
Accuracy of in-bed scales
Time frame: Immediate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: 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.
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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.
Mike Wells, MD, PhD study director
Research Professor
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.