Limb VolumeNCT06944041
Measuring Volume Using a 3D Scanner and iPad to Grade the Swelling of Legs
An observational study of Limb Volume and Measuring Edema, run by The RANE Center for Venous and Lymphatic Diseases at St. Dominic's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Limb Volume, Measuring Edema
- What is being tested?
- STO3 sensor (Structure Inc., Boulder, CO)
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to 20 Feb 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The target population will be symptom-free volunteers in order to establish a method of scanning for the best results. Volunteers in this study will have no coercion involved.
Who may be able to join
- The people in this study will be symptom free volunteers.
Who cannot join
- Pre-existing diseased limbs
Trial locations and contacts
1 site in 1 country.
United States1 site
The RANE Center for Venous and Lymphatic Diseases
Jackson, Mississippi, 39216
About this study
Official title: Limb Volumetry Using iPad Based 3D Scanner for Assessment of Edema
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.
Read the 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.
- Conditions
- Limb Volume, Measuring Edema
- Being tested
- STO3 sensor (Structure Inc., Boulder, CO)
- Keywords
- Leg swelling, 3-D Volumetry, phlebolymphedema, CEAP Clinical Class 3, Limb plethysmography, lymphedema
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STO3 sensor (Structure Inc., Boulder, CO)Other
The advent of Apple iPad based 3D scanner opens a new avenue for measuring limb volume. The latest ambient light scanner model was utilized for the current study. 3D scanning technology has gained broad industrial use, including the manufacturing of high-precision tools. A commercially available software package was used for limb volumetry.
| Study group | Role | What they receive |
|---|---|---|
| Twenty limbs from ten healthy volunteers | Not described Receives: Other: STO3 sensor (Structure Inc., Boulder, CO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Volume
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.
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start16 Apr 2024
- Primary completion31 Aug 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Limb VolumeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The RANE Center for Venous and Lymphatic Diseases at St. Dominic's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Seshadri Raju, The RANE Center for Venous and Lymphatic Diseases at St. Dominic's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944041
- Sponsor's protocol ID
- 2024-008-St. Dom
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The consent form clearly states that "We will not collect any protected health information in this study. Data collected will be as following: sex, age, weight, and volume of limbs." Therefore, there is no risk to patient confidentiality.
Publications
Marsocci A, Santandrea S, Lanfranchi E, Donati D, Tedeschi R. Beyond water: 3D laser scanning offers a cutting-edge alternative for upper limb volume assessment. Phlebology. 2025 Jul;40(6):400-408. doi: 10.1177/02683555241310358. Epub 2024 Dec 19.
PubMed 39701043Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg. 2000 Jun;31(6):1307-12. doi: 10.1067/mva.2000.107094.
PubMed 10842165Raju S, Owen S Jr, Neglen P. Reversal of abnormal lymphoscintigraphy after placement of venous stents for correction of associated venous obstruction. J Vasc Surg. 2001 Nov;34(5):779-84. doi: 10.1067/mva.2001.119396.
PubMed 11700475Katz ML, Comerota AJ, Kerr RP, Caputo GC. Variability of venous-hemodynamics with daily activity. J Vasc Surg. 1994 Feb;19(2):361-5. doi: 10.1016/s0741-5214(94)70111-3.
PubMed 8114195
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limb Volumetry Using iPad Based 3D Scanner for Assessment of Edema
- ClinicalTrials.gov ID
- NCT06944041
- Acronym / sponsor ID
- 2024-008-St. Dom
- Conditions
- Limb Volume, Measuring Edema
- Keywords
- Leg swelling, 3-D Volumetry, phlebolymphedema, CEAP Clinical Class 3, Limb plethysmography, lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The RANE Center for Venous and Lymphatic Diseases at St. Dominic's HospitalUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 25 Apr 2025 (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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Twenty limbs from ten healthy volunteers | – | Other: STO3 sensor (Structure Inc., Boulder, CO) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population will be symptom-free volunteers in order to establish a method of scanning for the best results. Volunteers in this study will have no coercion involved.
Key inclusion criteria (1 listed)
- The people in this study will be symptom free volunteers.
Key exclusion criteria (1 listed)
- Pre-existing diseased limbs
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 |
|---|---|---|
| STO3 sensor (Structure Inc., Boulder, CO)The advent of Apple iPad based 3D scanner opens a new avenue for measuring limb volume. The latest ambient light scanner model was utilized for the current study. 3D scanning technology has gained broad industrial use, including the manufacturing of high-precision tools. A commercially available software package was used for limb volumetry. | Other | Twenty limbs from ten healthy volunteers |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 39701043Marsocci A, Santandrea S, Lanfranchi E, Donati D, Tedeschi R. Beyond water: 3D laser scanning offers a cutting-edge alternative for upper limb volume assessment. Phlebology. 2025 Jul;40(6):400-408. doi: 10.1177/02683555241310358. Epub 2024 Dec 19.
- Background: PubMed 10842165Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg. 2000 Jun;31(6):1307-12. doi: 10.1067/mva.2000.107094.
- Background: PubMed 11700475Raju S, Owen S Jr, Neglen P. Reversal of abnormal lymphoscintigraphy after placement of venous stents for correction of associated venous obstruction. J Vasc Surg. 2001 Nov;34(5):779-84. doi: 10.1067/mva.2001.119396.
- Background: PubMed 8114195Katz ML, Comerota AJ, Kerr RP, Caputo GC. Variability of venous-hemodynamics with daily activity. J Vasc Surg. 1994 Feb;19(2):361-5. doi: 10.1016/s0741-5214(94)70111-3.
- Individual participant dataSharing planned: No. The consent form clearly states that "We will not collect any protected health information in this study. Data collected will be as following: sex, age, weight, and volume of limbs." Therefore, there is no risk to patient confidentiality.
Related trials for Limb Volume
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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 Limb Volume and Measuring Edema, run by The RANE Center for Venous and Lymphatic Diseases at St. Dominic's Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 May 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Limb Volume (time frame: During Procedure). 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 NCT06944041, which also lists 4 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 18 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.