Healthy SubjectsPhase 3NCT01590368
A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode
A Phase 3 study testing Marketed electrode and Modified "test" electrode in people with Healthy Subjects, run by ConvaTec Inc..
Trial summary
It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram (ECG) trace is comparable between the two groups (marketed and test products) after 30 minutes (the intended period of use) of the electrodes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Marketed electrode and Modified "test" electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2012
- Phase
- Phase 3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Provide written informed consent
- Be a healthy volunteer and be over 18 years of age
- Willing to attend two scheduled visits for application and removal of the device and adverse event review
- Have healthy unbroken skin
Who cannot join
- Subjects with a history of sensitivity to any one of the components of the device being studied
- Subjects who have a history of skin related disorders to the chest.
- Subjects who are actively involved in the development, manufacturing, quality and marketing of Unomedical electrodes
- Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
- Subjects who have any current cardiac conditions that may lead to an abnormal ECG trace
About this study
It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram (ECG) trace is comparable between the two groups (marketed and test products) after 30 minutes (the intended period of use) of the electrodes.
- Conditions
- Healthy Subjects
- Being tested
- Marketed electrode, Modified "test" electrode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed electrodeDevice
12 electrodes will be placed on the subject for an ECG reading to be taken
Modified "test" electrodeDevice
12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken
| Study group | Role | What they receive |
|---|---|---|
| Marketed electrode | Other | The currently marketed electrodes using the current CE marked adhesive Receives: Device: Marketed electrode |
| Modified hydrogel | Active comparator | Electrodes with the new modified adhesive - the "test" electrodes Receives: Device: Modified "test" electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Performance : Remain in place
Ability to remain in place for a duration of 30 minutes (as per intended use)
Measured: 30 minutes
Product Performance: Perform
Ability of the electrodes to perform after a duration of 30 minutes of wear (ECG tracing) as per intended use.
Measured: 30 minutes
Secondary outcomes (2)
Safety: Adverse Events
Safety will be evaluated by the nature and frequency of adverse events, (including condition of the skin under the electrodes using the Skin Irritation Scale (Appendix 4)) and ease of removal
Measured: 2 days
Skin Rating
Condition of the skin under the electrodes using the Skin Irritation Scale
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara A Schofield, Principal investigator, North Cheshire Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590368
- Sponsor's protocol ID
- UM-1015-12-U365
- Status last verified
- May 2012
- First submitted
- 1 May 2012
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode
- ClinicalTrials.gov ID
- NCT01590368
- Acronym / sponsor ID
- UM-1015-12-U365
- Conditions
- Healthy Subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 2 May 2012 (estimated)
- 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.
It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram (ECG) trace is comparable between the two groups (marketed and test products) after 30 minutes (the intended period of use) of the electrodes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marketed electrode | Other | Device: Marketed electrodeThe currently marketed electrodes using the current CE marked adhesive |
| Modified hydrogel | Active comparator | Device: Modified "test" electrodeElectrodes with the new modified adhesive - the "test" electrodes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Provide written informed consent
- Be a healthy volunteer and be over 18 years of age
- Willing to attend two scheduled visits for application and removal of the device and adverse event review
- Have healthy unbroken skin
Key exclusion criteria (5 listed)
- Subjects with a history of sensitivity to any one of the components of the device being studied
- Subjects who have a history of skin related disorders to the chest.
- Subjects who are actively involved in the development, manufacturing, quality and marketing of Unomedical electrodes
- Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
- Subjects who have any current cardiac conditions that may lead to an abnormal ECG trace
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 |
|---|---|---|
| Marketed electrode12 electrodes will be placed on the subject for an ECG reading to be taken | Device | Marketed electrode |
| Modified "test" electrode12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken | Device | Modified hydrogel |
Primary outcome
Product Performance : Remain in place
Time frame: 30 minutes
Ability to remain in place for a duration of 30 minutes (as per intended use)
Product Performance: Perform
Time frame: 30 minutes
Ability of the electrodes to perform after a duration of 30 minutes of wear (ECG tracing) as per intended use.
2 secondary outcomes
Safety: Adverse Events
Time frame: 2 days
Skin Rating
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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.
Barbara A Schofield principal investigator
North Cheshire Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Marketed electrode and Modified "test" electrode in people with Healthy Subjects, run by ConvaTec Inc..
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 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: status not confirmed, as of the sponsor's last update on 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Product Performance : Remain in place (time frame: 30 minutes). 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 4 May 2012.