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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03288766




Registration number
NCT03288766
Ethics application status
Date submitted
18/09/2017
Date registered
20/09/2017
Date last updated
20/10/2021

Titles & IDs
Public title
SHERLOCK 3CG™ Diamond Tip Confirmation System
Scientific title
A Single-Arm Prospective, Multi-Centered Study to Assess the SHERLOCK 3CG™ Diamond Tip Confirmation System
Secondary ID [1] 0 0
BAS-14-003
Universal Trial Number (UTN)
Trial acronym
MODUS II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Indication for Peripheral Intravenous Catheterization 0 0
Atrial Flutter 0 0
Premature Atrial Contraction 0 0
Premature Ventricular Contraction 0 0
Premature Junctional Contraction 0 0
Tachycardia 0 0
Atrioventricular Block 0 0
Bundle-Branch Block 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software

PICC Placement with Study Device - PICC Placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software


Treatment: Surgery: PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software
The SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) is an FDA-cleared fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology, indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients without any alterations of cardiac rhythms that change the normal presentation of the P-wave. A software package, MODUS II, has been developed to accurately analyze the entire ECG complex and identify the correct placement of the PICC tip based on a patient's individual ECG, in the absence of an easily identifiable P-wave. This software system is designed to provide visual and/or audio cues to notify the PICC placer of the location of the PICC tip relative to the cavoatrial junction (CAJ) of the patient.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2
Timepoint [1] 0 0
The PICC insertion procedure is 60-90 mins in duration
Secondary outcome [1] 0 0
Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2 in the absence of a GDI
Timepoint [1] 0 0
The PICC insertion procedure is 60-90 mins in duration
Secondary outcome [2] 0 0
Percent agreement between the site readings of the CXR (standard of care) versus those completed by an independent, blinded radiologist
Timepoint [2] 0 0
The PICC insertion procedure is 60-90 mins in duration

Eligibility
Key inclusion criteria
* Male or female, = 21 years of age with altered cardiac rhythm (no recognizable P-wave on standard ECG) with diagnosis of specific arrhythmia type or identification of pacemaker driven rhythms as defined below:

1. 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
2. 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
3. Pacemaker driven rhythm with temporary or permanent pacemaker device in place;
* Subject requires PICC placement as part of standard of care;
* Subject or Legally Authorized Representative (LAR) has signed an Informed Consent Form (ICF).
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has a contraindication to PICC placement as listed in the Instructions for Use (IFU) to include:

1. The presence of bacteremia or septicemia (known or suspected),
2. The patient's body size is insufficient to accommodate the size of the implanted device,
3. The patient is known or is suspected to be allergic to materials contained in the device,
4. Past irradiation of prospective insertion site,
5. Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site,
6. Local tissue factors will prevent proper device stabilization and/or access;
* Subjects who previously had a PICC in place and require a PICC exchange;
* Subject has presence of active resting tremor (i.e. Parkinson's, Multiple Sclerosis, etc.) deemed by Investigator to have potential impact on procedure accuracy;
* Subjects who are pregnant or think they may be pregnant.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2021
Sample size
Target
Accrual to date
Final
232
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Nevada
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
Country [5] 0 0
United States of America
State/province [5] 0 0
West Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
C. R. Bard
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT03288766
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rushil Sankpal
Address 0 0
Becton Dickinson
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03288766