HealthyHuman PatchNCT00767390
CARTO 3 Human Patch Study
An observational study of Healthy, run by Biosense Webster, Inc..
Trial summary
The Purpose of this clinical investigation is to observe the changes in relative conductivity between the six ACL patches over time. In addition, the clinical investigation will evaluate the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ACL Patch
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to not given
- Phase
- Observational
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Volunteers
Who may be able to join
- Signed Subject Informed Consent Form
- Healthy subject
- Age Range: 20 - 50 years
- BMI - half o the subjects 18-25 and half >25
- Chest cage normal anatomy and dimensions
- No history of skin contact patch allergy, of any kind
Who cannot join
- Chest cage bony deformity
- Known skin allergies to patches, or dermatological conditions requiring therapy
- Presence of any active skin lesion on chest or back
- Any condition that preclude subject from lying down for six hours with minimal movement
- Pregnancy
- Subjects with devices, such as pace makers, IC, loop recorder
About this study
Official title: CARTO 3 ACL Patches Effectiveness Over Prolonged Clinical Case
The Purpose of this clinical investigation is to observe the changes in relative conductivity between the six ACL patches over time. In addition, the clinical investigation will evaluate the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back. During the study the adhesiveness properties of the patches will be evaluated.
- Conditions
- Healthy
- Being tested
- ACL Patch
- Keywords
- ACL Patch Placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL PatchDevice
Observe and characterize the changes in relative conductivity between the six ACL patches over period of six hours. Investigation only involves passive data collection on pressure impact and adhesiveness properties of ACL patches.
| Study group | Role | What they receive |
|---|---|---|
| ACL Patch | Not described Receives: Device: ACL Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites.
Measured: 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 Oct 2008 (estimated)
- Study startOct 2008
Why it stopped: The required results were obtained through alternate methodology
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giris Jacob, M.D., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767390
- Sponsor's protocol ID
- Rep2952
- Acronym
- Human Patch
- Status last verified
- Oct 2015
- First submitted
- 3 Oct 2008
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARTO 3 ACL Patches Effectiveness Over Prolonged Clinical Case
- ClinicalTrials.gov ID
- NCT00767390
- Acronym / sponsor ID
- Human Patch / Rep2952
- Conditions
- Healthy
- Keywords
- ACL Patch Placement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The required results were obtained through alternate methodology
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- First posted
- 7 Oct 2008 (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.
The Purpose of this clinical investigation is to observe the changes in relative conductivity between the six ACL patches over time. In addition, the clinical investigation will evaluate the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back. During the study the adhesiveness properties of the patches will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL Patch | – | Device: ACL Patch |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Volunteers
Key inclusion criteria (6 listed)
- Signed Subject Informed Consent Form
- Healthy subject
- Age Range: 20 - 50 years
- BMI - half o the subjects 18-25 and half >25
- Chest cage normal anatomy and dimensions
Key exclusion criteria (6 listed)
- Chest cage bony deformity
- Known skin allergies to patches, or dermatological conditions requiring therapy
- Presence of any active skin lesion on chest or back
- Any condition that preclude subject from lying down for six hours with minimal movement
- Pregnancy
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 |
|---|---|---|
| ACL PatchObserve and characterize the changes in relative conductivity between the six ACL patches over period of six hours. Investigation only involves passive data collection on pressure impact and adhesiveness properties of ACL patches. | Device | ACL Patch |
Primary outcome
Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites.
Time frame: 6 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
Giris Jacob, M.D. principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Biosense Webster, 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 6 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: withdrawn, as of the sponsor's last update on 14 Oct 2015. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites. (time frame: 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 14 Oct 2015.