- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06646120
Machine Learning and 3D Image-Based Modeling for Real-Time Body Weight and Body Composition Estimation During Emergency Medical Care. Study 1
December 15, 2025 updated by: Florida Atlantic University
Machine Learning and 3D Image-Based Modeling for Real-Time Body Weight and Body Composition Estimation During Emergency Medical Care. Study 1 - Establish a Model Using a Single 3D Camera Image of a Supine Patient to Accurately Estimate TBW, IBW And LBW.
The goal of this observational study is to train and validate an AI-driven 3D camera system to estimate total body weight, ideal body weight and lean body weight in male and female adult volunteers of all ages. The main questions this study aims to answer are:
- What degree of accuracy of weight estimation can we achieve with an AI-driven 3D camera weight estimation system?
- Is this accuracy the same in adults of both sexes, all ages, and all body types (underweight, normal weight, overweight)? Participants will undergo some anthropometric measurements (height, mid-arm circumference, weight circumference, hip circumference, measured weight), a DXA scan (to measure lean body weight), and 3D imaging using a 3D camera.
There will be no interventions.
Study Overview
Status
Withdrawn
Detailed Description
This study is a single-centre observational study to train, internally validate, and test an AI-driven 3D camera weight estimation system.
Our hypothesis is that this system, when used in the management of acutely ill patients, will be able to estimate total body weight, ideal body weight, and lean body weight more accurately than other current point-of-care system.
Healthy volunteers will be used to train and test the system.
During a single data collection session of approximately 30 minutes, baseline anthropometric data, a DXA scan, and 3D camera images of volunteers lying on a medical stretcher will be captured.
There will be no interventions, and no follow up of participants.
The collected data will be used to train an AI algorithm (based on artificial neural networks) to estimate weight using a single depth image.
Once the AI system is fully evolved, the accuracy of its weight estimation performance will be evaluated in an independent test dataset.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Students, staff and faculty at the Boca Raton campus of Florida Atlantic University.
Description
Inclusion Criteria:
- Any willing volunteer.
Exclusion Criteria:
- 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.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TBW estimation
Time Frame: Baseline
|
Accuracy of TBW estimation using 3D camera system
|
Baseline
|
|
IBW estimation
Time Frame: Baseline
|
Accuracy of IBW estimation using 3D camera system
|
Baseline
|
|
LBW estimation
Time Frame: Baseline
|
Accuracy of LBW estimation using 3D camera system
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sex-related accuracy
Time Frame: Baseline
|
Difference in accuracy between males and females
|
Baseline
|
|
Age-related accuracy
Time Frame: Baseline
|
Accuracy of weight estimation by age-group
|
Baseline
|
|
BMI-related accuracy
Time Frame: Baseline
|
Accuracy of weight estimation by subgroup of weight status
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- Wells 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.
- Wells 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.
- Wells 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.
- Wells 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.
- Sonar VG, Jan MT, Wells M, Pandya A, Engstrom G, Shih R, Furht B. Estimating Body Volume and Height Using 3D Data. arxiv. 2024 September; 2410.02800
- Jan MT, Kumar A, Wells M, Pandya A, Engstrom G, Shih R, Furht B. Comprehensive Survey of Body Weight Estimation: Techniques, Datasets and Applications. Multimedia Tools and Applications. 2024 October
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)
July 1, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
October 15, 2024
First Submitted That Met QC Criteria
October 16, 2024
First Posted (Actual)
October 17, 2024
Study Record Updates
Last Update Posted (Actual)
December 19, 2025
Last Update Submitted That Met QC Criteria
December 15, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1791994(1)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Cloud point data of 3D images will be shared, on request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Body Weight in the Overweight and Obese Class - I Population
-
NovoBliss Research Pvt LtdAmbe Phytoextracts Pvt. LtdCompletedBody Weight in the Overweight and Obese Class - I PopulationIndia
-
Florida Atlantic UniversityWithdrawnBody Weight in the Overweight and Obese Class - I Population | Body Weights and Measures | Weight Estimation | Emergency Drug DosingUnited States
-
Florida Atlantic UniversityWithdrawnDrug Dose | Body Weight in the Overweight and Obese Class - I Population | Body Weights and Measures | Weight Estimate
-
Institut Pasteur de LilleLuxomedTerminatedAssess the Effect of an IR Reflexotherapy on Overweight and Class I Obese PeopleFrance
-
Johns Hopkins UniversityCompleted
-
Alain DagherNot yet recruitingClass I/II ObesityCanada
-
Eisai Inc.CompletedPharmacokinetics in Obese AdolescentsUnited States
-
University Hospital, RouenCompletedThromboprophylaxis in Hospitalized Obese PatientsFrance
-
Women and Infants Hospital of Rhode IslandUnknownManagement of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing.United States
-
University Health Network, TorontoThe Physicians' Services Incorporated FoundationCompletedRecovery Time From Isoflurane Anesthesia in Obese PatientsCanada