CompletedNot Applicable

Study to Assess Electrocardiogram Waveforms Produced Through the Utilization of the Sherlock 3CG™ Tip Confirmation System

United States182 participantsStarted 2013-11

Plain-language summary

This study was to gather real-time ECG data through the use of the SHERLOCK 3CG™ Tip Confirmation System (TCS), an electrocardiogram (ECG)-based peripherally-inserted central catheter (PICC) tip confirmation technology. The study was to promote the development of a software package (MODUS) that can accurately define the maximum P-wave on an ECG waveform. All study participants received PICCs as their standard of care.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Male or female, age ≥ 21 years
✓. Subject required PICC placement as part of standard of care
✓. Subject had signed an Informed Consent Form (ICF) or had an ICF signed by the subject's legally authorized representative

Exclusion criteria

✕. Subject had a contraindication to PICC placement as listed in the Instructions for Use (IFU)

What they're measuring

Percent agreement between maximum P-wave assessments of PICC nurse clinicians and the MODUS software during PICC insertion

Timeframe: The PICC insertion procedure is 60-90 mins in duration

Trial details

NCT IDNCT03028090

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-11

View on ClinicalTrials.gov More Indication for Peripheral Intravenous Catheterization trials