Fluid Retention TissueMaTcHNCT03072732
Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System
A study testing u-Cor System and ZOE Fluid Status Monitor in people with Fluid Retention Tissue, run by Zoll Medical Corporation at 3 sites in United States.
Trial summary
The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device. The µ-Cor System will record the fluid changes in the body, as well as ECG (electrocardiogram or an electrical tracing of your heart rhythm) heart rate, breathing rate, posture and… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Fluid Retention Tissue
- What is being tested?
- u-Cor System and ZOE Fluid Status Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Nov 2016to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women at least 21 years of age.
- Is currently scheduled to undergo hemodialysis 3 times per week in a clinic setting and has been on this regimen for at least 3 months.
- For those patients with CHF: were diagnosed with CHF by a qualified provider and show symptomatic signs of New York Heart Association (NYHA) Class II to IV at enrollment.
- Is prescribed a net fluid removal of at least 2.5 L during the hemodialysis session.
- Is willing and able to sign informed consent in English.
Who cannot join
- Is a female patient with a known pregnancy or is unsure of pregnancy status.
- Has known allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
- Has skin breakdown in areas where device and electrode placement is required.
- Was hospitalized within the 2 weeks prior to enrollment.
- Had intradialytic hypotension requiring administration of intravenous (IV) fluids of ≥250 mL or that resulted in a referral to urgent care, within 2 weeks prior to enrollment.
- Had myocardial infarction, acute coronary syndrome, or stroke within 4 weeks prior to enrollment.
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- Has active nephrotic syndrome
- Has severe malnutrition, as diagnosed per a qualified provider.
- Is participating in another clinical trial.
- Has an implanted device that might interfere with the µ-Cor.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DaVita Clinical Research
Lakewood, Colorado, 80228
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: Measuring Thoracic Impedance in Hemodialysis Patients With the µ-Cor System A Pre-Market Validation Study (MaTcH)
The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device. The µ-Cor System will record the fluid changes in the body, as well as ECG (electrocardiogram or an electrical tracing of your heart rhythm) heart rate, breathing rate, posture and activity at regular intervals.
The information collected by the µ-Cor System will then be compared to the actual fluid removed through dialysis and to the information collected by an FDA (Food and Drug Administration) cleared device called ZOE (NonInvasive Medical Technologies), a monitor which also measures the fluid changes in the body.
Read more
The objectives of this study are to document any differences in measurement of thoracic impedance obtained from the µ-Cor System and the ZOE system. Thoracic impedance is a measure of the electrical activity in the chest that varies with changes in body size and composition, fluid volume, breathing status and other variables.
Measurements of the amount of fluid removed during dialysis will also be compared between the µ-Cor System, the ZOE system and the actual fluid removed.
The ability of the µ-Cor System to measure thoracic impedance will be tested by placing the device randomly at one of two locations:
- Study Arm 1: side location- below left axilla
- Study Arm 2: front location - upper left pectoral area
Both the µ-Cor System and the ZOE System will be worn simultaneously during one dialysis session. The ZOE system device is placed on the chest- 2 points: 1 at the base of your neck and 1 in your mid chest.
Read the detailed description
The µ-Cor System is intended to record, store, transmit, and display the following physiological data to medical professionals: thoracic impedance, ECG, heart rate, respiration rate, activity and posture.
The µ-Cor System is indicated for patients who are 21 years of age or older who:
- have fluid-management problems,
- are taking diuretic medication,
- are living with heart failure,
- are living with end-stage renal disease,
- are recovering from a coronary artery disease-related event, and/or
- are suffering from recurrent dehydration.
Objectives:
- This clinical trial is intended to provide evidence of substantial equivalence between the µ-Cor System and the ZOE System in the ability to measure thoracic impedance, by comparing the correlation between µ Cor measurement and ultrafiltration volume (UFV) as compared with the correlation between ZOE measurement and UFV. The actual UFV changes will be used to arbitrate any differences.
- The ability of the µ-Cor System to measure thoracic impedance will be demonstrated at 2 body locations: side location (below left axilla, Study Arm 1), and front location (upper left pectoral area, Study Arm 2).
Subject population:
Forty patients undergoing hemodialysis (n = 40) in 2 study arms with at least 50% enrollment of patients diagnosed with congestive heart failure (CHF) in each arm:
- Study Arm 1: 20 patients undergoing hemodialysis, with at least 10 of these patients having CHF, will have the µ-Cor device placed on the side location
- Study Arm 2: 20 patients undergoing hemodialysis, with at least 10 of these patients having CHF, will have the µ-Cor device placed on the front location
Patients will wear the µ-Cor device and will be connected to the ZOE monitor during one hemodialysis session in the clinic. Patients will be randomly allocated to Study Arm 1 or Study Arm 2, with randomization stratified by CHF status (CHF or non-CHF). During the hemodialysis session, the patient will wear 1 µ-Cor device and will be connected simultaneously to 1 ZOE monitor (via 2 ZOE electrodes) for comparative measurements and UFV correlation, from at least 15 minutes before the start of dialysis to at least 15 minutes after the end of the dialysis session. The µ-Cor will record measurements during the dialysis session, including at least the 15 minutes before and 15 minutes after the session. ZOE (Z0) values will be measured every 6 minutes (± 1 minute) during the dialysis session. ZOE (Z0) values also will be measured every 3 minutes (± 1 minute) before and after the session, for a minimum of 5 measurements. The UFV during the course of hemodialysis will be measured by automated readings provided by the dialysis machine every 6 minutes (± 1 minute). 10. Any IV infusions administered, oral fluid or solid intake, and urine output during the course of hemodialysis will be recorded. Weight, blood pressure, and heart rate will be recorded before and after the dialysis session.The patient's involvement in the study ends after the completion of all procedures planned for the hemodialysis session.
- Conditions
- Fluid Retention Tissue
- Being tested
- u-Cor System, ZOE Fluid Status Monitor
- Keywords
- Heart Failure, Hemodialysis
- Medical subject headings
- Edema, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
u-Cor SystemDevice
Also called u-Cor V3.0 System
Monitoring System
ZOE Fluid Status MonitorDevice
Monitoring System
| Study group | Role | What they receive |
|---|---|---|
| study arm 1 - below left axilla | Other | 20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed below left axilla and the ZOE Fluid Status Monitor Receives: Device: u-Cor System; Device: ZOE Fluid Status Monitor |
| study arm 2-upper left pectoral area | Other | 20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed on the upper left pectoral area and the ZOE Fluid Status Monitor Receives: Device: u-Cor System; Device: ZOE Fluid Status Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Correlation of Thoracic Impedance With Ultra-filtration Volume (UFV) Between uCor and ZOE
The primary endpoint measurement is the difference of 1) the Pearson correlation of thoracic impedance made by the u-Cor System to UFV and 2) the Pearson correlation of thoracic impedance made by the ZOE to UFV. Differences in correlation coefficients were calculated for each subject and each study arm.
Measured: 15 minutes prior the start of one hemodialysis session to 15 minutes post completion of one hemodialysis session, approximately 2 to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start3 Nov 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fluid Retention TissueStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Madhuri Bhat, MS, Study director, Zoll Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072732
- Sponsor's protocol ID
- 2016-KM-004
- Acronym
- MaTcH
- Status last verified
- Oct 2020
- First submitted
- 1 Mar 2017
- Last updated
- 4 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Thoracic Impedance in Hemodialysis Patients With the µ-Cor System A Pre-Market Validation Study (MaTcH)
- ClinicalTrials.gov ID
- NCT03072732
- Acronym / sponsor ID
- MaTcH / 2016-KM-004
- Conditions
- Fluid Retention Tissue
- Keywords
- Heart Failure, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Posted 4 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device. The µ-Cor System will record the fluid changes in the body, as well as ECG (electrocardiogram or an electrical tracing of your heart rhythm) heart rate, breathing rate, posture and activity at regular intervals.
The information collected by the µ-Cor System will then be compared to the actual fluid removed through dialysis and to the information collected by an FDA (Food and Drug Administration) cleared device called ZOE (NonInvasive Medical Technologies), a monitor which also measures the fluid changes in the body.
The objectives of this study are to document any differences in measurement of thoracic impedance obtained from the µ-Cor System and the ZOE system. Thoracic impedance is a measure of the electrical activity in the chest that varies with changes in body size and composition, fluid volume, breathing status and other variables.
Measurements of the amount of fluid removed during dialysis will also be compared between the µ-Cor System, the ZOE system and the actual fluid removed.
The ability of the µ-Cor System to measure thoracic impedance will be tested by placing the device randomly at one of two locations:
- Study Arm 1: side location- below left axilla
- Study Arm 2: front location - upper left pectoral area
Both the µ-Cor System and the ZOE System will be worn simultaneously during one dialysis session. The ZOE system device is placed on the chest- 2 points: 1 at the base of your neck and 1 in your mid chest.
Detailed description
The µ-Cor System is intended to record, store, transmit, and display the following physiological data to medical professionals: thoracic impedance, ECG, heart rate, respiration rate, activity and posture.
The µ-Cor System is indicated for patients who are 21 years of age or older who:
- have fluid-management problems,
- are taking diuretic medication,
- are living with heart failure,
- are living with end-stage renal disease,
- are recovering from a coronary artery disease-related event, and/or
- are suffering from recurrent dehydration.
Objectives:
- This clinical trial is intended to provide evidence of substantial equivalence between the µ-Cor System and the ZOE System in the ability to measure thoracic impedance, by comparing the correlation between µ Cor measurement and ultrafiltration volume (UFV) as compared with the correlation between ZOE measurement and UFV. The actual UFV changes will be used to arbitrate any differences.
- The ability of the µ-Cor System to measure thoracic impedance will be demonstrated at 2 body locations: side location (below left axilla, Study Arm 1), and front location (upper left pectoral area, Study Arm 2).
Subject population:
Forty patients undergoing hemodialysis (n = 40) in 2 study arms with at least 50% enrollment of patients diagnosed with congestive heart failure (CHF) in each arm:
- Study Arm 1: 20 patients undergoing hemodialysis, with at least 10 of these patients having CHF, will have the µ-Cor device placed on the side location
- Study Arm 2: 20 patients undergoing hemodialysis, with at least 10 of these patients having CHF, will have the µ-Cor device placed on the front location
Patients will wear the µ-Cor device and will be connected to the ZOE monitor during one hemodialysis session in the clinic. Patients will be randomly allocated to Study Arm 1 or Study Arm 2, with randomization stratified by CHF status (CHF or non-CHF). During the hemodialysis session, the patient will wear 1 µ-Cor device and will be connected simultaneously to 1 ZOE monitor (via 2 ZOE electrodes) for comparative measurements and UFV correlation, from at least 15 minutes before the start of dialysis to at least 15 minutes after the end of the dialysis session. The µ-Cor will record measurements during the dialysis session, including at least the 15 minutes before and 15 minutes after the session. ZOE (Z0) values will be measured every 6 minutes (± 1 minute) during the dialysis session. ZOE (Z0) values also will be measured every 3 minutes (± 1 minute) before and after the session, for a minimum of 5 measurements. The UFV during the course of hemodialysis will be measured by automated readings provided by the dialysis machine every 6 minutes (± 1 minute). 10. Any IV infusions administered, oral fluid or solid intake, and urine output during the course of hemodialysis will be recorded. Weight, blood pressure, and heart rate will be recorded before and after the dialysis session.The patient's involvement in the study ends after the completion of all procedures planned for the hemodialysis session.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-arm study
| Arm | Type | Receives |
|---|---|---|
| study arm 1 - below left axilla | Other | Device: u-Cor System, Device: ZOE Fluid Status Monitor20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed below left axilla and the ZOE Fluid Status Monitor |
| study arm 2-upper left pectoral area | Other | Device: u-Cor System, Device: ZOE Fluid Status Monitor20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed on the upper left pectoral area and the ZOE Fluid Status Monitor |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women at least 21 years of age.
- Is currently scheduled to undergo hemodialysis 3 times per week in a clinic setting and has been on this regimen for at least 3 months.
- For those patients with CHF: were diagnosed with CHF by a qualified provider and show symptomatic signs of New York Heart Association (NYHA) Class II to IV at enrollment.
- Is prescribed a net fluid removal of at least 2.5 L during the hemodialysis session.
- Is willing and able to sign informed consent in English.
Key exclusion criteria (10 listed)
- Is a female patient with a known pregnancy or is unsure of pregnancy status.
- Has known allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
- Has skin breakdown in areas where device and electrode placement is required.
- Was hospitalized within the 2 weeks prior to enrollment.
- Had intradialytic hypotension requiring administration of intravenous (IV) fluids of ≥250 mL or that resulted in a referral to urgent care, within 2 weeks prior to enrollment.
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 |
|---|---|---|
| u-Cor SystemAlso: u-Cor V3.0 SystemMonitoring System | Device | study arm 1 - below left axilla, study arm 2-upper left pectoral area |
| ZOE Fluid Status MonitorMonitoring System | Device | study arm 1 - below left axilla, study arm 2-upper left pectoral area |
Primary outcome
Difference in Correlation of Thoracic Impedance With Ultra-filtration Volume (UFV) Between uCor and ZOE
Time frame: 15 minutes prior the start of one hemodialysis session to 15 minutes post completion of one hemodialysis session, approximately 2 to 6 hours.
The primary endpoint measurement is the difference of 1) the Pearson correlation of thoracic impedance made by the u-Cor System to UFV and 2) the Pearson correlation of thoracic impedance made by the ZOE to UFV. Differences in correlation coefficients were calculated for each subject and each study arm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Recruiting
Transitional Care Program for Fluid Overload in Cirrhosis
Cirrhosis, Liver
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.
Madhuri Bhat, MS study director
Zoll Medical Corporation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing u-Cor System and ZOE Fluid Status Monitor in people with Fluid Retention Tissue, run by Zoll Medical Corporation at 3 sites 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 5 inclusion and 10 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 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Correlation of Thoracic Impedance With Ultra-filtration Volume (UFV) Between uCor and ZOE (time frame: 15 minutes prior the start of one hemodialysis session to 15 minutes post completion of one hemodialysis session, approximately 2 to 6 hours.). 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 4 Nov 2020.