Lymphedema ArmNCT06778837
Lymphedema Sensor Technology Development Study
An observational study of Lymphedema Arm and Lymphedema, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this clinical trial in adult patients diagnosed with upper extremity lymphedema is to test the safety and effectiveness of small, wearable sensors that may be able to measure lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema Arm, Lymphedema, Cancer
- What is being tested?
- Wearable devices to detect lymphedema
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2025to 14 Dec 2025
- How long will I take part?
- 2 Weeks
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will recruit patients using the above specified criteria in the Chicagoland area.
Who may be able to join
- Patients with a diagnosis of unilateral lymphedema that affects the upper extremity (UE).
- Patients previously diagnosed with non-metastatic cancer.
- Adults 18 years of age and older.
Who cannot join
- Patients with history of lymphatic surgery.
- Patients with implantable devices (e.g., pacemaker, pacemaker/defibrillator, intrathecal pump, joint replacements, etc.) or any other device deemed unsafe by the treating investigator.
- Patients with an amputation involving the upper extremity.
- Patients with known allergies to adhesives - including silicone adhesives.
- Patients with the following comorbidities: diabetes, congestive heart failure, peripheral vascular disease, irradiated upper extremity skin, psoriasis, atopic dermatitis, open wounds/skin breakdown.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Wearable Sensors to Monitor Tissue Hydration and Stiffness in Patients With Lymphedema
The goal of this clinical trial in adult patients diagnosed with upper extremity lymphedema is to test the safety and effectiveness of small, wearable sensors that may be able to measure lymphedema. The main questions this study aims to answer are:
- Do these sensors detect lymphedema?
- If so, how accurate are these wearable sensors?
Participants will complete one in-person measurement session and one phone call with study staff 14 days after the measurement session to check-in on the participant's well-being.
- Conditions
- Lymphedema Arm, Lymphedema, Cancer
- Being tested
- Wearable devices to detect lymphedema
- Keywords
- Sensor, Device, Lymphedema, Upper Extremity, Wearable, Tissue, Hydration, Stiffness, Cancer
- Medical subject headings
- Lymphedema, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable devices to detect lymphedemaDevice
All participants will undergo measurement of the upper extremities to test the validity and safety of wearable sensors to measure lymphedema.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Not described Receives: Device: Wearable devices to detect lymphedema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Hydration Score Recorded from the Tissue Hydration Sensor
This score will determine whether or not fluid associated with lymphedema is detected when compared to previously validated measures (bioimpedance spectroscopy and tissue dielectric constant). This is a continuous ratio level of measurement.
Measured: From enrollment to the end of the measurement session (appx. 3 hours)
Tissue Stiffness Score from the Tissue Stiffness Sensor
This score will determine whether or not tissue affected by lymphedema can yield is detected when compared to a comparable clinical measurement device using Young's Modulus. This is a continuous ratio level of measurement.
Measured: From enrollment to the end of the measurement session (appx. 3 hours)
Secondary outcomes (3)
Bioimpedance spectroscopy (BIS) L-Dex score
The bioimpedance spectroscopy L-Dex score is a ratio that represents the difference in the amount of extracellular fluid in an at-risk limb compared to an unaffected limb.
Measured: Three hours
Tissue Dielectric Constant (TDC)
The tissue dielectric constant (TDC) is derived from an electromagnetic wave that is reflected back from transmission into the tissue. It represents free and bound water in the tissue.
Measured: From enrollment to the end of the measurement session (appx. 3 hours)
Volume of the Upper Extremities
Circumferential volumetric measurement is obtained by modeling the limb as a frustum and taking a series of circumferential measurements using anatomical landmarks at predetermined intervals (typically every 4cm), beginning at the wrist and ending at the anterior axillary fold. Volume differences of +10% represents the presence of lymphedema.
Measured: Three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start27 Jan 2025
- Primary completion3 Dec 2025
- Study completion14 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema ArmStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert H. Lurie Cancer Center
- Responsible party
- Principal investigator, Ann Marie Flores, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778837
- Sponsor's protocol ID
- STU00222670
- Status last verified
- Dec 2025
- First submitted
- 2 Jan 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Wearable Sensors to Monitor Tissue Hydration and Stiffness in Patients With Lymphedema
- ClinicalTrials.gov ID
- NCT06778837
- Acronym / sponsor ID
- STU00222670
- Conditions
- Lymphedema Arm, Lymphedema, Cancer
- Keywords
- Sensor, Device, Lymphedema, Upper Extremity, Wearable, Tissue, Hydration, Stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Robert H. Lurie Cancer Center
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 14 Dec 2025 (actual)
- First posted
- 16 Jan 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.
The goal of this clinical trial in adult patients diagnosed with upper extremity lymphedema is to test the safety and effectiveness of small, wearable sensors that may be able to measure lymphedema. The main questions this study aims to answer are:
- Do these sensors detect lymphedema?
- If so, how accurate are these wearable sensors?
Participants will complete one in-person measurement session and one phone call with study staff 14 days after the measurement session to check-in on the participant's well-being.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Device: Wearable devices to detect lymphedema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit patients using the above specified criteria in the Chicagoland area.
Key inclusion criteria (3 listed)
- Patients with a diagnosis of unilateral lymphedema that affects the upper extremity (UE).
- Patients previously diagnosed with non-metastatic cancer.
- Adults 18 years of age and older.
Key exclusion criteria (5 listed)
- Patients with history of lymphatic surgery.
- Patients with implantable devices (e.g., pacemaker, pacemaker/defibrillator, intrathecal pump, joint replacements, etc.) or any other device deemed unsafe by the treating investigator.
- Patients with an amputation involving the upper extremity.
- Patients with known allergies to adhesives - including silicone adhesives.
- Patients with the following comorbidities: diabetes, congestive heart failure, peripheral vascular disease, irradiated upper extremity skin, psoriasis, atopic dermatitis, open wounds/skin breakdown.
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 |
|---|---|---|
| Wearable devices to detect lymphedemaAll participants will undergo measurement of the upper extremities to test the validity and safety of wearable sensors to measure lymphedema. | Device | All Participants |
Primary outcome
Tissue Hydration Score Recorded from the Tissue Hydration Sensor
Time frame: From enrollment to the end of the measurement session (appx. 3 hours)
This score will determine whether or not fluid associated with lymphedema is detected when compared to previously validated measures (bioimpedance spectroscopy and tissue dielectric constant). This is a continuous ratio level of measurement.
Tissue Stiffness Score from the Tissue Stiffness Sensor
Time frame: From enrollment to the end of the measurement session (appx. 3 hours)
This score will determine whether or not tissue affected by lymphedema can yield is detected when compared to a comparable clinical measurement device using Young's Modulus. This is a continuous ratio level of measurement.
3 secondary outcomes
Bioimpedance spectroscopy (BIS) L-Dex score
Time frame: Three hours
Tissue Dielectric Constant (TDC)
Time frame: From enrollment to the end of the measurement session (appx. 3 hours)
Volume of the Upper Extremities
Time frame: Three hours
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 30 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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 Lymphedema Arm and Lymphedema, run by Northwestern University 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 3 inclusion and 5 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 30 Dec 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?
Tissue Hydration Score Recorded from the Tissue Hydration Sensor (time frame: From enrollment to the end of the measurement session (appx. 3 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025.