TerminatedNot Applicable

SHERLOCK 3CG™ Diamond Tip Confirmation System

Stopped: Low enrollment

United States232 participantsStarted 2018-04-19

Plain-language summary

This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally inserted central catheters (PICCs) in adult subjects with altered cardiac rhythm.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Atrial fibrillation with history of diagnosis per 12-lead ECG in medical record or diagnosed via bedside telemetry by study team RN at assessment, or
✓. All other arrhythmias (including but not limited to atrial flutter, PAC, PVC, PJC, tachycardia, AV Block, BB Block) with history of diagnosis per 12-lead ECG in medical record or diagnosed via bedside telemetry by cardiac unit RN at assessment, or retrospectively by site cardiologist, or
✓. Pacemaker driven rhythm with temporary or permanent pacemaker device in place;

Exclusion criteria

✕. The presence of bacteremia or septicemia (known or suspected),
✕. The patient's body size is insufficient to accommodate the size of the implanted device,
✕. The patient is known or is suspected to be allergic to materials contained in the device,
✕. Past irradiation of prospective insertion site,
✕. Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site,
✕. Local tissue factors will prevent proper device stabilization and/or access;

What they're measuring

Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2

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

Trial details

NCT IDNCT03288766

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-06-15

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