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

NCT03028090 | Completed

• 1 other identifier: BAS-13-001
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Indication for Peripheral Intravenous Catheterization

Outcome Measures

Primary Outcomes (1)

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

  The measurement used will be percent agreement between clinician and MODUS software. Agreement of 95% between the nurse clinician and software assessments will be used to validate the study hypothesis.

  The PICC insertion procedure is 60-90 mins in duration

Interventions

SHERLOCK 3CG™ Tip Confirmation System with MODUS Software DEVICE

The SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients. In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for the clinician, Bard Access Systems, Inc. is developing MODUS, a software package.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population was to be comprised of a sufficient number of subjects so that a minimum of 201 subjects completed the study, but no more than 250 subjects were to be enrolled.

You may qualify if:

• A subject must have met the following criteria to be enrolled in the study:
• 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

You may not qualify if:

• A subject was excluded if any of the following criteria were met:
• Subject had a contraindication to PICC placement as listed in the Instructions for Use (IFU)

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (2)

Memorial Health System

Colorado Springs, Colorado, 80909, United States

Location

Bethesda North Hospital

Montgomery, Ohio, 45242, United States

Location

Study Officials

• Gina Gilbert, BSN

  CR Bard

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: January 23, 2017
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

US (2)