Trials / Completed
CompletedNCT05278871
Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
A Pilot Study of Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Microelastic Ultrasound Systems Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This proof of concept study will evaluate the ability of a new, ultrasound based technology called Bullseye Constructive Shearwave Interference (CSI) (trade name, Bullseye Elasticity Quantification) to measure lymphedema of the upper arm among breast cancer survivors. The study's hypothesis is that the CSI device can detect the presence of clinically significant lymphedema when compared with the standard arm tape measurement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Constructive Shearwave Interference (CSI) | handheld ultrasound |
Timeline
- Start date
- 2022-05-26
- Primary completion
- 2023-08-31
- Completion
- 2023-08-31
- First posted
- 2022-03-14
- Last updated
- 2023-12-13
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05278871. Inclusion in this directory is not an endorsement.