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Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

NCT05278871 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-12-13

No results posted yet for this study

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

DEVICE

Constructive Shearwave Interference (CSI)

handheld ultrasound

Sponsors & Collaborators

  • Duke Health

    collaborator OTHER

  • Microelastic Ultrasound Systems Inc

    lead INDUSTRY

Principal Investigators

  • Susan McDuff, MD PhD · Duke Health

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-26
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05278871 on ClinicalTrials.gov