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A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01590368
Recruitment Status : Unknown
Verified May 2012 by ConvaTec Inc..
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2012
Last Update Posted : May 4, 2012
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.

Tracking Information
First Submitted Date  ICMJE May 1, 2012
First Posted Date  ICMJE May 2, 2012
Last Update Posted Date May 4, 2012
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01590368 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
  • Safety: Adverse Events [ Time Frame: 2 days ]
    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
  • Skin Rating [ Time Frame: 2 days ]
    Condition of the skin under the electrodes using the Skin Irritation Scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode
Official Title  ICMJE A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Device: Marketed electrode
    12 electrodes will be placed on the subject for an ECG reading to be taken
  • Device: Modified "test" electrode
    12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken
Study Arms  ICMJE
  • Marketed electrode
    The currently marketed electrodes using the current CE marked adhesive
    Intervention: Device: Marketed electrode
  • Active Comparator: Modified hydrogel
    Electrodes with the new modified adhesive - the "test" electrodes
    Intervention: Device: Modified "test" electrode
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 1, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01590368
Other Study ID Numbers  ICMJE UM-1015-12-U365
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ConvaTec Inc.
Study Sponsor  ICMJE ConvaTec Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara A Schofield North Cheshire Hospital
PRS Account ConvaTec Inc.
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP