TelemetryNCT02533531
Proof of Concept Study for 1 Lead Patch Technology
A study testing 1-Lead Patch in people with Telemetry, run by LifeWatch Services, Inc. at 1 site in United States.
Trial summary
This study is intended to assess the feasibility and usability of the 1 Lead Patch as a whole, on patients outside the hospital, in the out-patient setting. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Telemetry
- What is being tested?
- 1-Lead Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2014to 9 Jun 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female referred for 3 Lead ACT monitoring for between 7 and 14 days.
- Be recently prescribed a LifeWatch 3 Lead ACT monitor
Who cannot join
- under 21-years old
- pregnant or who may become become pregnant during the investigation period
- using internal or external defibrillators
- who are using pacemakers or implantable loop recorders
- showing skin damage on the chest, such as burns, irritation, infections, wounds, etc.
- meeting any contraindications for a patch biosensor
Trial locations and contacts
1 site in 1 country.
About this study
This study is intended to assess the feasibility and usability of the 1 Lead Patch as a whole, on patients outside the hospital, in the out-patient setting.
Read the detailed description
This study is a two-phase evaluation of the use of a 1 Lead Patch System to monitor electrocardiogram (ECG) data and send the data to the LifeWatch Service Center, in the same manner as the existing ACT ambulatory telemetry system. It will be used in parallel with the standard 3 Lead ACT testing equipment used to monitor ECG outside the hospital. This study will not address safety or effectiveness and no comparator groups will be used. This study will not be treating any particular disease or condition and no randomization or blinding is required. Subjects will be selected in conjunction with their need for current outpatient telemetry monitoring.
- Conditions
- Telemetry
- Being tested
- 1-Lead Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Lead PatchDevice
The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database.
| Study group | Role | What they receive |
|---|---|---|
| 1-Lead Outpatient Telemetry | Experimental | 1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database. Receives: Device: 1-Lead Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Outcome Measure - 100% Successful ECG Acquisition
Successful acquisition of ECG data by the 1-Lead patch with transmission to the central database via the gateway. Each patch includes a 'brain' that collects the ECG data and then transmits it to a cellular device called the 'gateway'. The gateway uses the cellular network to transmit the data to the central database. This is a composite outcome measure. Data were not collected.
Measured: Between 7 and 14 days
Secondary outcomes (1)
Composite Outcome Measure - Adhesive Performance - Measurement of Skin Irritation Resulting From Adhesive Used With 1-Lead Patch
Successful performance of the 1-Lead Patch adhesive throughout the study period for each subject. Subject skin irritation will be assessed upon initial placement of the 1-Lead Patch by the clinical caregiver. Subjects will be asked to self-assess skin irritation and to report to the clinician at the end of the trail period. Data were not collected.
Measured: Between 7 and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study start16 Apr 2014
- Primary completion9 Jun 2016
- Study completion9 Jun 2016
Why it stopped: Study was halted to make device updates
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 TelemetryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeWatch Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, MD FACC FHRS, Principal investigator, Mt. Sinai Medical CenterMarie Noelle-Langan, MD, Principal investigator, Mt. Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533531
- Sponsor's protocol ID
- CIP-F010
- Status last verified
- Mar 2018
- First submitted
- 25 Aug 2015
- Last updated
- 6 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study for 1 Lead Patch Technology
- ClinicalTrials.gov ID
- NCT02533531
- Acronym / sponsor ID
- CIP-F010
- Conditions
- Telemetry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was halted to make device updates
- Enrolment
- 1 participants (actual)
- Lead sponsor
- LifeWatch Services, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2014 (actual)
- Primary completion
- 9 Jun 2016 (actual)
- Study completion
- 9 Jun 2016 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Posted 6 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to assess the feasibility and usability of the 1 Lead Patch as a whole, on patients outside the hospital, in the out-patient setting.
Detailed description
This study is a two-phase evaluation of the use of a 1 Lead Patch System to monitor electrocardiogram (ECG) data and send the data to the LifeWatch Service Center, in the same manner as the existing ACT ambulatory telemetry system. It will be used in parallel with the standard 3 Lead ACT testing equipment used to monitor ECG outside the hospital. This study will not address safety or effectiveness and no comparator groups will be used. This study will not be treating any particular disease or condition and no randomization or blinding is required. Subjects will be selected in conjunction with their need for current outpatient telemetry monitoring.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1-Lead Outpatient Telemetry | Experimental | Device: 1-Lead Patch1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male or female referred for 3 Lead ACT monitoring for between 7 and 14 days.
- Be recently prescribed a LifeWatch 3 Lead ACT monitor
Key exclusion criteria (6 listed)
- under 21-years old
- pregnant or who may become become pregnant during the investigation period
- using internal or external defibrillators
- who are using pacemakers or implantable loop recorders
- showing skin damage on the chest, such as burns, irritation, infections, wounds, etc.
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 |
|---|---|---|
| 1-Lead PatchThe 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database. | Device | 1-Lead Outpatient Telemetry |
Primary outcome
Composite Outcome Measure - 100% Successful ECG Acquisition
Time frame: Between 7 and 14 days
Successful acquisition of ECG data by the 1-Lead patch with transmission to the central database via the gateway. Each patch includes a 'brain' that collects the ECG data and then transmits it to a cellular device called the 'gateway'. The gateway uses the cellular network to transmit the data to the central database. This is a composite outcome measure. Data were not collected.
1 secondary outcome
Composite Outcome Measure - Adhesive Performance - Measurement of Skin Irritation Resulting From Adhesive Used With 1-Lead Patch
Time frame: Between 7 and 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Vivek Reddy, MD FACC FHRS principal investigator
Mt. Sinai Medical Center
Marie Noelle-Langan, MD principal investigator
Mt. Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-Lead Patch in people with Telemetry, run by LifeWatch Services, Inc. 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 2 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: stopped early, as of the sponsor's last update on 6 Apr 2018. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2018). 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?
Composite Outcome Measure - 100% Successful ECG Acquisition (time frame: Between 7 and 14 days). 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 6 Apr 2018.