Body Weights and MeasuresNCT06646133
Machine Learning and 3D Image-Based Modeling for Real-Time Body Weight and Body Composition Estimation During Emergency Medical Care: Study 2
An observational study of Body Weights and Measures and Body Weight in the Overweight and Obese Class - I Population, run by Florida Atlantic University at 1 site in United States.
Trial summary
The goal of this prospective crossover simulation study is to evaluate the accuracy and usability of a 3D camera weight estimation system during simulated emergency care in adult simulated patients, when used by emergency physicians. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Weights and Measures, Body Weight in the Overweight and Obese Class - I Population, Weight Estimation
- What is being tested?
- 3D camera weight estimate and Standard methods of weight estimation
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 28 Feb 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Simulated patients will be enrolled from students, staff and faculty at the Boca Raton campus of Florida Atlantic university. Emergency physician participants will be enrolled from resident and attending emergency physicians in south Florida.
Who may be able to join
- Any volunteer aged ≥18 years.
- Any willing emergency medicine resident or attending physician.
Who cannot join
- Participants with a body weight exceeding the DXA machine capacity >204kg (450lbs);
- Pregnant participants; participants with medical conditions that could confound the study;
- Participants with any metallic surgical implants;
- Participants who have had an x-ray with contrast in the past week;
- Participants who have taken calcium supplements in the 24 hours prior to the study.
- Any physical limitation to performing anthropometric measurements as part of simulation scenario.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Atlantic University
Boca Raton, Florida, 33143
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: Study 2 - Measure the Accuracy and Speed of Weight Estimations Using a 3D Camera System During Simulated Medical Emergencies
The goal of this prospective crossover simulation study is to evaluate the accuracy and usability of a 3D camera weight estimation system during simulated emergency care in adult simulated patients, when used by emergency physicians. The main questions the study aims to answer are:
- to evaluate the accuracy of 3D camera weight estimation during simulated emergency care, when compared with standard methods
- to evaluate the usability of 3D camera weight estimation during emergency care, when compared with standard methods
- to evaluate the inter-user reliability of 3D camera weight estimates Volunteers for simulated patients will be required to have anthropometric measurements, a DXA scan, and 3D camera weight estimates.
Read more
Physician volunteers will need to participate in simulated emergency scenarios during which weight-based therapy must be administered.
There will be no interventions.
Read the detailed description
The performance of the 3D camera system needs to be evaluated in conditions in which it will be used in a clinical setting, but without the risk to patients. It also needs to be compared against other, standard, methods of weight estimation. In addition the downstream accuracy of drug doses, with the correct use of alternative dose scalars (such as ideal body weight or lean body weight) in patients with obesity needs to be evaluated.
In this prospective crossover simulation study, resident and attending emergency physician volunteers will conduct simulated emergency care on simulated patient volunteers. The physicians will be randomised to start with either 3D camera systems, or standard care systems. After completing the scenario they will perform a new simulation scenario on a different patient using standard methods of weight estimation (crossover). At the end of the data collection session, each physician will have performed four scenarios (two standard methods, two 3D camera methods). Each simulated patient will similarly have participated in two standard method scenarios and two 3D camera scenarios. Each simulated patient and each physician will only have a single encounter.
In this way the accuracy of weight estimation and drug dosing can be compared between the 3D camera system and standard methods. In addition, inter-rater reliability can be determined and compared between resident and attending physicians.
- Conditions
- Body Weights and Measures, Body Weight in the Overweight and Obese Class - I Population, Weight Estimation, Emergency Drug Dosing
- Being tested
- 3D camera weight estimate, Standard methods of weight estimation
- Keywords
- weight estimation, emergency drug dosing, 3D camera, computer vision
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D camera weight estimateDiagnostic test
Weight estimation using 3D camera system
Standard methods of weight estimationDiagnostic test
Standard methods of weight estimation will be used
| Study group | Role | What they receive |
|---|---|---|
| Standard care weight estimation | Simulated patients in whom standard methods of weight estimation will be used. Receives: Diagnostic Test: Standard methods of weight estimation | |
| 3D camera weight estimation | Simulated patients in whom 3D camera estimates of weight will be used. Receives: Diagnostic Test: 3D camera weight estimate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight estimation accuracy
The accuracy of estimations of total body weight, ideal body weight and lean body weight will be compared against ground truth data, and against other weight estimation systems.
Measured: During the simulation (intervention) procedure
Weight estimation time
The time taken to obtain a weight estimate will be compared against other weight estimation systems.
Measured: During the simulation (intervention) procedure
Drug dose accuracy
The accuracy of drug doses calculated using estimated weight will be compared against a ground truth value, and compared with other weight estimation systems.
Measured: During the simulation (intervention) procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Jul 2027 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Why it stopped: No funding received.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Body Weights and MeasuresStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646133
- Sponsor's protocol ID
- 1791994(2)
- Status last verified
- Dec 2025
- First submitted
- 15 Oct 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be made available on request.
Publications
Wells M, Goldstein L. Appropriate Statistical Analysis and Data Reporting for Weight Estimation Studies. Pediatr Emerg Care. 2023 Jan 1;39(1):62-63. doi: 10.1097/PEC.0000000000002862. Epub 2022 Oct 1. No abstract available.
PubMed 36190388Wells M, Goldstein LN, Cattermole G. Development and Validation of a Length- and Habitus-Based Method of Ideal and Lean Body Weight Estimation for Adults Requiring Urgent Weight-Based Medical Intervention. Eur J Drug Metab Pharmacokinet. 2022 Nov;47(6):841-853. doi: 10.1007/s13318-022-00796-3. Epub 2022 Sep 19.
PubMed 36123560Wells M, Goldstein LN. Estimating Lean Body Weight in Adults With the PAWPER XL-MAC Tape Using Actual Measured Weight as an Input Variable. Cureus. 2022 Sep 17;14(9):e29278. doi: 10.7759/cureus.29278. eCollection 2022 Sep.
PubMed 36277563Wells M, Henry B, Goldstein L. Weight Estimation for Drug Dose Calculations in the Prehospital Setting - A Systematic Review. Prehosp Disaster Med. 2023 Aug;38(4):471-484. doi: 10.1017/S1049023X23006027. Epub 2023 Jul 13.
PubMed 37439214Wells M, Goldstein LN, Alter SM, Solano JJ, Engstrom G, Shih RD. The accuracy of total body weight estimation in adults - A systematic review and meta-analysis. Am J Emerg Med. 2024 Feb;76:123-135. doi: 10.1016/j.ajem.2023.11.037. Epub 2023 Nov 29.
PubMed 38056057Wells M, Goldstein LN, Wells T, Ghazi N, Pandya A, Furht B, Engstrom G, Jan MT, Shih R. Total body weight estimation by 3D camera systems: Potential high-tech solutions for emergency medicine applications? A scoping review. J Am Coll Emerg Physicians Open. 2024 Oct 4;5(5):e13320. doi: 10.1002/emp2.13320. eCollection 2024 Oct.
PubMed 39371964
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 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: Study 2 - Measure the Accuracy and Speed of Weight Estimations Using a 3D Camera System During Simulated Medical Emergencies
- ClinicalTrials.gov ID
- NCT06646133
- Acronym / sponsor ID
- 1791994(2)
- Conditions
- Body Weights and Measures, Body Weight in the Overweight and Obese Class - I Population, Weight Estimation, Emergency Drug Dosing
- Keywords
- weight estimation, emergency drug dosing, 3D camera, computer vision
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding received.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 17 Oct 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 prospective crossover simulation study is to evaluate the accuracy and usability of a 3D camera weight estimation system during simulated emergency care in adult simulated patients, when used by emergency physicians. The main questions the study aims to answer are:
- to evaluate the accuracy of 3D camera weight estimation during simulated emergency care, when compared with standard methods
- to evaluate the usability of 3D camera weight estimation during emergency care, when compared with standard methods
- to evaluate the inter-user reliability of 3D camera weight estimates Volunteers for simulated patients will be required to have anthropometric measurements, a DXA scan, and 3D camera weight estimates.
Physician volunteers will need to participate in simulated emergency scenarios during which weight-based therapy must be administered.
There will be no interventions.
Detailed description
The performance of the 3D camera system needs to be evaluated in conditions in which it will be used in a clinical setting, but without the risk to patients. It also needs to be compared against other, standard, methods of weight estimation. In addition the downstream accuracy of drug doses, with the correct use of alternative dose scalars (such as ideal body weight or lean body weight) in patients with obesity needs to be evaluated.
In this prospective crossover simulation study, resident and attending emergency physician volunteers will conduct simulated emergency care on simulated patient volunteers. The physicians will be randomised to start with either 3D camera systems, or standard care systems. After completing the scenario they will perform a new simulation scenario on a different patient using standard methods of weight estimation (crossover). At the end of the data collection session, each physician will have performed four scenarios (two standard methods, two 3D camera methods). Each simulated patient will similarly have participated in two standard method scenarios and two 3D camera scenarios. Each simulated patient and each physician will only have a single encounter.
In this way the accuracy of weight estimation and drug dosing can be compared between the 3D camera system and standard methods. In addition, inter-rater reliability can be determined and compared between resident and attending physicians.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care weight estimation | – | Diagnostic Test: Standard methods of weight estimationSimulated patients in whom standard methods of weight estimation will be used. |
| 3D camera weight estimation | – | Diagnostic Test: 3D camera weight estimateSimulated patients in whom 3D camera estimates of weight will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Simulated patients will be enrolled from students, staff and faculty at the Boca Raton campus of Florida Atlantic university. Emergency physician participants will be enrolled from resident and attending emergency physicians in south Florida.
Key inclusion criteria (2 listed)
- Any volunteer aged ≥18 years.
- Any willing emergency medicine resident or attending physician.
Key exclusion criteria (6 listed)
- Participants with a body weight exceeding the DXA machine capacity >204kg (450lbs);
- Pregnant participants; participants with medical conditions that could confound the study;
- Participants with any metallic surgical implants;
- Participants who have had an x-ray with contrast in the past week;
- Participants who have taken calcium supplements in the 24 hours prior to 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 |
|---|---|---|
| 3D camera weight estimateWeight estimation using 3D camera system | Diagnostic test | 3D camera weight estimation |
| Standard methods of weight estimationStandard methods of weight estimation will be used | Diagnostic test | Standard care weight estimation |
Primary outcome
Weight estimation accuracy
Time frame: During the simulation (intervention) procedure
The accuracy of estimations of total body weight, ideal body weight and lean body weight will be compared against ground truth data, and against other weight estimation systems.
Weight estimation time
Time frame: During the simulation (intervention) procedure
The time taken to obtain a weight estimate will be compared against other weight estimation systems.
Drug dose accuracy
Time frame: During the simulation (intervention) procedure
The accuracy of drug doses calculated using estimated weight will be compared against a ground truth value, and compared with other weight estimation systems.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 36190388Wells M, Goldstein L. Appropriate Statistical Analysis and Data Reporting for Weight Estimation Studies. Pediatr Emerg Care. 2023 Jan 1;39(1):62-63. doi: 10.1097/PEC.0000000000002862. Epub 2022 Oct 1. No abstract available.
- Background: PubMed 36123560Wells M, Goldstein LN, Cattermole G. Development and Validation of a Length- and Habitus-Based Method of Ideal and Lean Body Weight Estimation for Adults Requiring Urgent Weight-Based Medical Intervention. Eur J Drug Metab Pharmacokinet. 2022 Nov;47(6):841-853. doi: 10.1007/s13318-022-00796-3. Epub 2022 Sep 19.
- Background: PubMed 36277563Wells M, Goldstein LN. Estimating Lean Body Weight in Adults With the PAWPER XL-MAC Tape Using Actual Measured Weight as an Input Variable. Cureus. 2022 Sep 17;14(9):e29278. doi: 10.7759/cureus.29278. eCollection 2022 Sep.
- Background: PubMed 37439214Wells M, Henry B, Goldstein L. Weight Estimation for Drug Dose Calculations in the Prehospital Setting - A Systematic Review. Prehosp Disaster Med. 2023 Aug;38(4):471-484. doi: 10.1017/S1049023X23006027. Epub 2023 Jul 13.
- Background: PubMed 38056057Wells M, Goldstein LN, Alter SM, Solano JJ, Engstrom G, Shih RD. The accuracy of total body weight estimation in adults - A systematic review and meta-analysis. Am J Emerg Med. 2024 Feb;76:123-135. doi: 10.1016/j.ajem.2023.11.037. Epub 2023 Nov 29.
- Background: PubMed 39371964Wells M, Goldstein LN, Wells T, Ghazi N, Pandya A, Furht B, Engstrom G, Jan MT, Shih R. Total body weight estimation by 3D camera systems: Potential high-tech solutions for emergency medicine applications? A scoping review. J Am Coll Emerg Physicians Open. 2024 Oct 4;5(5):e13320. doi: 10.1002/emp2.13320. eCollection 2024 Oct.
- Individual participant dataSharing planned: Yes. The data will be made available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Weights and Measures and Body Weight in the Overweight and Obese Class - I Population, run by Florida Atlantic University at 1 site in United States.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight estimation accuracy (time frame: During the simulation (intervention) procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06646133, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.