Limb Volumetry Using iPad Based 3D Scanner for Assessment of Edema
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Limb Volume
Study Overview
Brief Summary
We used a new and easy-to-measure iPad 3D scanner to measure swelling in lower limbs because current technology is not easily available or affordable. We want to see how reliable the measurements are and what might affect how consistent they are.
Detailed Description
Twenty limbs from ten healthy volunteers were scanned using an iPad-based Structure Sensor and software. Initial scans followed standard manufacturer instructions, but high variance rendered data unsuitable for clinical use. To improve accuracy, a standardized scanning protocol was developed, incorporating anatomical calibration, scanning distance standardization, and scanning time control. A 254-mm calf segment was defined using a 3D marker placed on the medial malleolus to ensure consistent volume measurement. The scanning distance was fixed between 50-59 cm to reduce zoom parallax errors, and scans were conducted after 3 PM to minimize diurnal volume fluctuations. Multiple technicians performed repeat scans on the same limb to assess intra-observer and inter-observer scan reliability.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The people in this study will be symptom free volunteers.
Exclusion Criteria
- •Pre-existing diseased limbs
Outcomes
Primary Outcomes
Limb Volume
Time Frame: During Procedure
The scanning protocol and the required modifications of "out of the box" instructions for optimal clinical application are described; The 10 inch (254mm) long limb segment scanned must be anatomically constant. We chose the medial malleolus as the lower border of the scan. The scannable limb volume is 254 mm long, measured up from the malleolus.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Seshadri Raju
Principal Investigator
The RANE Center for Venous and Lymphatic Diseases at St. Dominic's Hospital