Lymphedema of LegNCT05485454
A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema
A study testing Aria Health Aria Free and A Traditional PCD in people with Lymphedema of Leg and Lymphedema, run by ResMed at 1 site in United States.
Trial summary
This study will aim to undertake a preference evaluation comparing the Aria Health Aria Free™ to a competitor's device by assessing overall satisfaction and preference of the devices individually and in comparison to one another. Twenty (20) subjects will be enrolled on this study at one study site in Houston, Texas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema of Leg, Lymphedema, Lymphedema, Secondary
- What is being tested?
- Aria Health Aria Free and A Traditional PCD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2022to 30 Jul 2022
- Phase
- Interventional
- 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
Who may be able to join
- Male and female patients who are ≥ 18 years, mentally able to understand and follow the instructions of the study personnel
- A diagnosis of unilateral or bilateral lower limb lymphedema
- A physician's prescription for use of a pneumatic compression device
- Able to provide written informed consent
- Patient can read and comprehend English
- Study leg must be within fit range of the Aria Free Garment (Ankle Max = 35cm/13.78in; Thigh Max = 80cm/34.49in)
Who cannot join
- Subject undergoing cancer treatment
- Subject has active lower limb wounds
- Subject is pregnant or trying to become pregnant
- History of pulmonary edema or decompensated congestive heart failure
- Subject has any condition in which increased venous and lymphatic return is undesirable
- Subject has inbuilt electrical stimulator, e.g., cardiac pacemaker
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- Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
- Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene)
- Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Cross-Over Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema
This study will aim to undertake a preference evaluation comparing the Aria Health Aria Free™ to a competitor's device by assessing overall satisfaction and preference of the devices individually and in comparison to one another. Twenty (20) subjects will be enrolled on this study at one study site in Houston, Texas.
Read the detailed description
This research study is studying the preference of the compact Aria Health Aria Free™ Pneumatic Compression System ('Aria Free,' 'Aria') as a treatment for Lower Limb Lymphedema when compared to a traditional pneumatic compression device. A pneumatic compression device is also known as a 'PCD.' Both PCDs used in this study have been approved by United States Food and Drug Administration (FDA) for the treatment of lower limb lymphedema and are Code E0651 pneumatic compression devices, as defined by the Centers for Medicare \& Medicaid Services (CMS) under The Healthcare Common Procedure Coding System (HCPCS) for Durable Medical Equipment (DME). Subjects participating in this study are asked to use each PCD for a short therapy session and then answer a series of questionnaires regarding their experience with the devices.
Participation in this study requires one clinic visit that will last about two (2) hours. At the beginning of the visit, the Investigator will ask each subject a series of questions to collect demographic data, and medical and pneumatic compression device usage history. The Investigator will then ask the subject to 'inspect' (touch and handle) the two PCDs used in this study and ask a few questions about the subject's opinion of the two devices based on this inspection. The Investigator will then guide the subject through completion of two (2) thirty (30) minute therapy sessions, one session using the Aria and the other session using the traditional PCD. The order in which the sessions are completed will be random, like the flip of a coin. Before and after each therapy session, the Investigator will complete a series of measurements and take photographs of the subject's lower limbs. The Investigator will also assess the subject's skin and tissue health after each intervention. Subjects will also be asked to complete questionnaires after each therapy session that will ask about subjective satisfaction with and preference between the two devices. Once the study visit has been completed, the subject will have completed the study and may return to his/her usual standard of care activities for treating his/her lower limb lymphedema.
- Conditions
- Lymphedema of Leg, Lymphedema, Lymphedema, Secondary, Lymphedema Primary, Lymphedema, Lower Limb
- Being tested
- Aria Health Aria Free, A Traditional PCD
- Keywords
- Pneumatic Compression Device
- Medical subject headings
- Lymphedema, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aria Health Aria FreeDevice
An in-clinic therapy session with the Aria Free for a duration of 30 minutes under the direct supervision of the Principal Investigator.
A Traditional PCDDevice
An in-clinic therapy session with the traditional PCD for a duration of 30 minutes under the direct supervision of the Principal Investigator.
| Study group | Role | What they receive |
|---|---|---|
| Aria Health Aria Free | Active comparator | An Aria Free therapy session on the study lower limb. Receives: Device: Aria Health Aria Free |
| Traditional PCD | Active comparator | A therapy session using the traditional PCD on the study lower limb. Receives: Device: A Traditional PCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction and Preference
The primary outcome of this study is to compare levels of subjective ratings of satisfaction and preference measurements after completed sessions with Aria Free and the traditional PCD devices. Each session is 30 minutes in duration. Subjective measures for each device will use an 11-point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.
Measured: Satisfaction and Preference ratings will be assessed during the only study visit: Visit 1/Day 1.
Secondary outcomes (2)
Limb Volume Measurements
The Principal Investigator will collect pre and post intervention circumferential limb measurements for each subject and these measurements will be used in a truncated cone formula to calculate total limb volume. Each intervention is 30 minutes in duration. The pre and post total limb volume measurements will be compared and assessed for change.
Measured: Limb volume measurements will be collected during the only study visit: Visit 1/Day 1.
Clinician's Skin and Tissue Health Assessment
The Principal Investigator will assess the skin and tissue health of the study lower limb after each intervention. Each intervention is 30 minutes in duration. Twenty observations are listed for the Investigator to document 'Yes' or 'No' if any of the observations are present or not, respectively, during the lower limb physical exam.
Measured: The skin and tissue will be assessed during the only study visit: Visit 1/Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start11 Jun 2022
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of LegStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lymphatic Solutions, LLC
- Responsible party
- Sponsor
- Investigators
- Denise M Baylor, CLT-LANA, Principal investigator, Lymphatic Solutions, Owner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485454
- Sponsor's protocol ID
- AF22-04-01
- Status last verified
- Sep 2022
- First submitted
- 18 Jul 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual Participant Data available will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Cross-Over Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema
- ClinicalTrials.gov ID
- NCT05485454
- Acronym / sponsor ID
- AF22-04-01
- Conditions
- Lymphedema of Leg, Lymphedema, Lymphedema, Secondary, Lymphedema Primary, Lymphedema, Lower Limb
- Keywords
- Pneumatic Compression Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- Lymphatic Solutions, LLC
- Study start
- 11 Jun 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 3 Aug 2022 (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.
This study will aim to undertake a preference evaluation comparing the Aria Health Aria Free™ to a competitor's device by assessing overall satisfaction and preference of the devices individually and in comparison to one another. Twenty (20) subjects will be enrolled on this study at one study site in Houston, Texas.
Detailed description
This research study is studying the preference of the compact Aria Health Aria Free™ Pneumatic Compression System ('Aria Free,' 'Aria') as a treatment for Lower Limb Lymphedema when compared to a traditional pneumatic compression device. A pneumatic compression device is also known as a 'PCD.' Both PCDs used in this study have been approved by United States Food and Drug Administration (FDA) for the treatment of lower limb lymphedema and are Code E0651 pneumatic compression devices, as defined by the Centers for Medicare \& Medicaid Services (CMS) under The Healthcare Common Procedure Coding System (HCPCS) for Durable Medical Equipment (DME). Subjects participating in this study are asked to use each PCD for a short therapy session and then answer a series of questionnaires regarding their experience with the devices.
Participation in this study requires one clinic visit that will last about two (2) hours. At the beginning of the visit, the Investigator will ask each subject a series of questions to collect demographic data, and medical and pneumatic compression device usage history. The Investigator will then ask the subject to 'inspect' (touch and handle) the two PCDs used in this study and ask a few questions about the subject's opinion of the two devices based on this inspection. The Investigator will then guide the subject through completion of two (2) thirty (30) minute therapy sessions, one session using the Aria and the other session using the traditional PCD. The order in which the sessions are completed will be random, like the flip of a coin. Before and after each therapy session, the Investigator will complete a series of measurements and take photographs of the subject's lower limbs. The Investigator will also assess the subject's skin and tissue health after each intervention. Subjects will also be asked to complete questionnaires after each therapy session that will ask about subjective satisfaction with and preference between the two devices. Once the study visit has been completed, the subject will have completed the study and may return to his/her usual standard of care activities for treating his/her lower limb lymphedema.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aria Health Aria Free | Active comparator | Device: Aria Health Aria FreeAn Aria Free therapy session on the study lower limb. |
| Traditional PCD | Active comparator | Device: A Traditional PCDA therapy session using the traditional PCD on the study lower limb. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients who are ≥ 18 years, mentally able to understand and follow the instructions of the study personnel
- A diagnosis of unilateral or bilateral lower limb lymphedema
- A physician's prescription for use of a pneumatic compression device
- Able to provide written informed consent
- Patient can read and comprehend English
Key exclusion criteria (9 listed)
- Subject undergoing cancer treatment
- Subject has active lower limb wounds
- Subject is pregnant or trying to become pregnant
- History of pulmonary edema or decompensated congestive heart failure
- Subject has any condition in which increased venous and lymphatic return is undesirable
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 |
|---|---|---|
| Aria Health Aria FreeAn in-clinic therapy session with the Aria Free for a duration of 30 minutes under the direct supervision of the Principal Investigator. | Device | Aria Health Aria Free |
| A Traditional PCDAn in-clinic therapy session with the traditional PCD for a duration of 30 minutes under the direct supervision of the Principal Investigator. | Device | Traditional PCD |
Primary outcome
Satisfaction and Preference
Time frame: Satisfaction and Preference ratings will be assessed during the only study visit: Visit 1/Day 1.
The primary outcome of this study is to compare levels of subjective ratings of satisfaction and preference measurements after completed sessions with Aria Free and the traditional PCD devices. Each session is 30 minutes in duration. Subjective measures for each device will use an 11-point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.
2 secondary outcomes
Limb Volume Measurements
Time frame: Limb volume measurements will be collected during the only study visit: Visit 1/Day 1.
Clinician's Skin and Tissue Health Assessment
Time frame: The skin and tissue will be assessed during the only study visit: Visit 1/Day 1.
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 15 Sep 2022.
- Individual participant dataSharing planned: No. Individual Participant Data available will not be shared with other researchers.
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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.
Denise M Baylor, CLT-LANA principal investigator
Lymphatic Solutions, Owner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aria Health Aria Free and A Traditional PCD in people with Lymphedema of Leg and Lymphedema, run by ResMed 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 6 inclusion and 9 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 15 Sep 2022. 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?
Satisfaction and Preference (time frame: Satisfaction and Preference ratings will be assessed during the only study visit: Visit 1/Day 1.). 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 15 Sep 2022.