Lymphedema of LimbNCT04226287
Compact Pneumatic Compression Device for Patients With Lymphedema
A study testing Monterey Pneumatic Compression Device in people with Lymphedema of Limb, run by ResMed at 1 site in United States.
Trial summary
This is a pilot study for usability and efficacy, and as such it is designed for 15 participants. The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphedema of Limb
- What is being tested?
- Monterey Pneumatic Compression Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2020to 31 Aug 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are ≥ 18 years, mentally able to understand and follow the instructions of the study personnel.
- A diagnosis of lower limb Lymphedema.
- Able to provide written and informed consent.
- Patient can read and comprehend English.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Progressive Physical Therapy and Rehab
Garden Grove, California, 92843
About this study
Official title: Pilot Study of a Compact Pneumatic Compression Device for Patients With Lymphedema
This is a pilot study for usability and efficacy, and as such it is designed for 15 participants.
The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting.
The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting over one week of daily use. Usability will be determined using a 11 point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.
- Conditions
- Lymphedema of Limb
- Being tested
- Monterey Pneumatic Compression Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monterey Pneumatic Compression DeviceDevice
The MontereyInvestigational System is a compact pneumatic compression device used for the treatment of either primary or secondary lymphedema. The primary intention in this study is to gather usability design feedback. This will be done by observing how a patient uses the device after a brief demonstration from the clinician. Errors and difficulties will be noted by the ResMed representative observing the trial. The qualitative interview with the patient at the end of the trial will yield additional understanding of the patient experience with the device.
| Study group | Role | What they receive |
|---|---|---|
| Monterey Pneumatic Compression Device | Experimental | All participants will receive treatment with the Monterey investigational pneumatic compression device Receives: Device: Monterey Pneumatic Compression Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the Monterey Investigational System in a monitored clinic environment
Usability will be determined using a 11 point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.
Measured: 1 week
Secondary outcomes (1)
Efficacy of Therapy provided by Monterey Investigational system
Efficacy will be determined by comparing lower limb volume measured prior to commencing therapy and at the conclusion. The truncated cone formula is a well-established measure used for assessing limb volume [1]. The limb is divided into segments as per figure 2, measurements taken and volume in each segment is calculated as per the following formula: Voln = L/12(pi)(C1^2+C2^2+C1*C2)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start16 Jun 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of LimbStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226287
- Sponsor's protocol ID
- A0015
- Status last verified
- Oct 2020
- First submitted
- 9 Jan 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Compact Pneumatic Compression Device for Patients With Lymphedema
- ClinicalTrials.gov ID
- NCT04226287
- Acronym / sponsor ID
- A0015
- Conditions
- Lymphedema of Limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 13 Jan 2020 (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 is a pilot study for usability and efficacy, and as such it is designed for 15 participants.
The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting.
The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting over one week of daily use. Usability will be determined using a 11 point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monterey Pneumatic Compression Device | Experimental | Device: Monterey Pneumatic Compression DeviceAll participants will receive treatment with the Monterey investigational pneumatic compression device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are ≥ 18 years, mentally able to understand and follow the instructions of the study personnel.
- A diagnosis of lower limb Lymphedema.
- Able to provide written and informed consent.
- Patient can read and comprehend English.
Key exclusion criteria (6 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 |
|---|---|---|
| Monterey Pneumatic Compression DeviceThe MontereyInvestigational System is a compact pneumatic compression device used for the treatment of either primary or secondary lymphedema. The primary intention in this study is to gather usability design feedback. This will be done by observing how a patient uses the device after a brief demonstration from the clinician. Errors and difficulties will be noted by the ResMed representative observing the trial. The qualitative interview with the patient at the end of the trial will yield additional understanding of the patient experience with the device. | Device | Monterey Pneumatic Compression Device |
Primary outcome
Usability of the Monterey Investigational System in a monitored clinic environment
Time frame: 1 week
Usability will be determined using a 11 point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.
1 secondary outcome
Efficacy of Therapy provided by Monterey Investigational system
Time frame: 1 week
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 22 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Lymphedema of Limb
Recruiting
The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema (the LymphEx Study)
Lymphedema
Recruiting
Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema
Lymphedema, Lower Limb, Extracorporeal Shock Wave Therapy
RecruitingPhase 2
A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer
Breast Cancer
RecruitingObservational study
Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis
Lymphedema, Microbiota
Not yet recruiting
Aerobic Exercise Effects in Lower Extremity Lymphedema
Lower Extremity Lymphedema
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?
A study testing Monterey Pneumatic Compression Device in people with Lymphedema of Limb, 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 4 inclusion and 6 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 22 Oct 2020. 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?
Usability of the Monterey Investigational System in a monitored clinic environment (time frame: 1 week). 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 22 Oct 2020.