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临床试验/NCT06646120
NCT06646120撤回不适用

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.

Florida Atlantic University0 个研究点目标入组 800 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
800
主要终点
TBW estimation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any willing volunteer.

排除标准

  • 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.

结局指标

主要结局

TBW estimation

时间窗: Baseline

Accuracy of TBW estimation using 3D camera system

IBW estimation

时间窗: Baseline

Accuracy of IBW estimation using 3D camera system

LBW estimation

时间窗: Baseline

Accuracy of LBW estimation using 3D camera system

次要结局

  • Sex-related accuracy(Baseline)
  • Age-related accuracy(Baseline)
  • BMI-related accuracy(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

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