Patients With PICC-Line3CGNCT02929368
SHERLOCK 3CG vs. Fluoroscopy in Implantation of PICC-Line
A study testing PICC implantation under fluoroscopy and PICC Implantation under Sherlock System in people with Patients With PICC-Line, run by Jena University Hospital at 1 site in Germany.
Trial summary
Peripherally inserted central catheters, or PICC lines, has now been successfully in use for many years, especially in the chemotherapeutic treatment of oncologic patients or in parenertal nutrition. The implantation of PICC lines is mostly performed under x-ray (fluoroscopy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With PICC-Line
- What is being tested?
- PICC implantation under fluoroscopy and PICC Implantation under Sherlock System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female, male
- adults ≥ 18 years
- medical indication for Power-PICC-Line catheter implantation because of chemotherapy or parenertal nutrition
- in- and outpatients
Who cannot join
- children and adolescents < 18 years
- systemic or local infection of the interventional location
- known allergy to used material
- general contraindication of Power-PICC-Line catheter implantation
- nonexistent sinus rhythm (5)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Noninferiority Study to Evaluate Safety and Efficacy of the Integrated Magnetic Tracking and ECG-guided Tip Location System (SHERLOCK 3CG) vs. Fluoroscopy in Implantation of Peripherally Inserted Central Catheter
Peripherally inserted central catheters, or PICC lines, has now been successfully in use for many years, especially in the chemotherapeutic treatment of oncologic patients or in parenertal nutrition. The implantation of PICC lines is mostly performed under x-ray (fluoroscopy). The aim of the clinical study is to assess the safety and the efficacy of the SHERLOCK-Systems eliminating the confirmatory chest x-ray exposure. Additionally, the SHERLOCK-System immediately confirms the PICC tip position even at the bedside of the patient, thus, saving costs and time.
Read the detailed description
Peripherally inserted central catheters, or PICC lines, are clinically used for many years in the treatment of patients, whereby the implantation occurs under x-ray/fluoroscopy. Female and male patients of legal age that have the medical indication for Power-PICC-Line catheter implantation can be screened for the study. These medical indications include the necessity of chemotherapy in the course of an oncological treatment or parenteral nutrition. The study objective is to test the efficacy and safety of the SHERLOCK system, evaluated by a monocentric, randomized-controlled study. The advantage for the participating patients lies in a reduced radiation exposure due to the discontinued final chest x-ray examination (fluoroscopy). Furthermore, the SHERLOCK system can be deployed directly on ward, at the patient's bedside leading to a cost and time saving. Recruited in- and outpatients (of legal age) with indication for Power-PICC-Line catheter implantation will be randomly assigned to one of the two arms (fluoroscopy or SHERLOCK). Depending on randomization, the Power-PICC implantation occurs either under fluoroscopy or with the SHERLOCK system. All related substances, measures or procedures are performed according to the clinical routine. The medical device is a fully integrated magnetic tracking and ECG-based peripherally inserted central catheter (PICC) tip confirmation technology applied on patients with normal sinus rhythm and placed through a peripheral vein. The Sherlock system is CE-certified since December 2011.
The referral of patients with indication to PICC-Line implantation at the institute of diagnostic and interventional radiology occurs through different departments of the University Hospital Jena. The patients are registered for radiological treatment and checked again by a radiologist if a PICC-Line implantation is indicated. If this is the case, the radiologist conducts an informed consent discussion with the patient about possible complications and risks during intervention and informs him also about a possible study. After signature of the written informed consent, the patient is included. On the intervention day, the patient is randomly assigned to one of the two study arms through RandomTool (Sherlock vs. fluoroscopy). According to randomization group, the PICC catheter is implanted (duration: 30 minutes) and eventually a chest x-ray (fluoroscopy) is performed to assess safety and efficacy.The intervention time from puncture to catheter placement is documented. After intervention, the patient is transferred back to the ward or sent home in hemodynamically stable conditions. The examination of the puncture site before discharge is performed by a ward physician or by the family doctor. 24 h after PICC-Line implantation, the treating physician is contacted and questioned about possible complications (catheter occlusion, haematoma, infection of the puncture site, arm vein thrombosis, pain, etc.), that are then thoroughly documented.
- Conditions
- Patients With PICC-Line
- Being tested
- PICC implantation under fluoroscopy, PICC Implantation under Sherlock System
- Keywords
- PICC-Line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICC implantation under fluoroscopyDevice
PICC Catheter implantation
PICC Implantation under Sherlock SystemDevice
PICC Catheter implantation
| Study group | Role | What they receive |
|---|---|---|
| Fluoroscopy | Active comparator | PICC Implantation under x-ray Receives: Device: PICC implantation under fluoroscopy |
| Sherlock System (BARD) | Active comparator | PICC Implantation with Integrated Magnetic Tracking and ECG-guided Tip Location System Receives: Device: PICC Implantation under Sherlock System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tip Placement efficiency measured by chest radiograph
Corect placement through anatomic evaluation of chest x-ray measuring catheter tip max. two vertebral bodies under carina
Measured: through study completion, an average of 2 years
Secondary outcomes (2)
Safety measured by follow-up interview with referring physician and documentation of AE
Documentation of periprocedural complications
Measured: Follow-up within one week
Implantation time
time during PICC implantation
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With PICC-LineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulf Teichgräber, Jena University Hospital
- Investigators
- Heike Habrecht, Dr. med., Principal investigator, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929368
- Sponsor's protocol ID
- 4567/10/15
- Acronym
- 3CG
- Status last verified
- Mar 2020
- First submitted
- 1 Jul 2016
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mack V, Nissler D, Kasikci D, Malouhi A, Aschenbach R, Teichgraber U. Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System Versus Fluoroscopy for Placement of Peripherally Inserted Central Catheters: A Randomized, Noninferiority Comparison. Cardiovasc Intervent Radiol. 2020 Dec;43(12):1891-1897. doi: 10.1007/s00270-020-02551-0. Epub 2020 Jun 17.
PubMed 32556606
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Noninferiority Study to Evaluate Safety and Efficacy of the Integrated Magnetic Tracking and ECG-guided Tip Location System (SHERLOCK 3CG) vs. Fluoroscopy in Implantation of Peripherally Inserted Central Catheter
- ClinicalTrials.gov ID
- NCT02929368
- Acronym / sponsor ID
- 3CG / 4567/10/15
- Conditions
- Patients With PICC-Line
- Keywords
- PICC-Line
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripherally inserted central catheters, or PICC lines, has now been successfully in use for many years, especially in the chemotherapeutic treatment of oncologic patients or in parenertal nutrition. The implantation of PICC lines is mostly performed under x-ray (fluoroscopy). The aim of the clinical study is to assess the safety and the efficacy of the SHERLOCK-Systems eliminating the confirmatory chest x-ray exposure. Additionally, the SHERLOCK-System immediately confirms the PICC tip position even at the bedside of the patient, thus, saving costs and time.
Detailed description
Peripherally inserted central catheters, or PICC lines, are clinically used for many years in the treatment of patients, whereby the implantation occurs under x-ray/fluoroscopy. Female and male patients of legal age that have the medical indication for Power-PICC-Line catheter implantation can be screened for the study. These medical indications include the necessity of chemotherapy in the course of an oncological treatment or parenteral nutrition. The study objective is to test the efficacy and safety of the SHERLOCK system, evaluated by a monocentric, randomized-controlled study. The advantage for the participating patients lies in a reduced radiation exposure due to the discontinued final chest x-ray examination (fluoroscopy). Furthermore, the SHERLOCK system can be deployed directly on ward, at the patient's bedside leading to a cost and time saving. Recruited in- and outpatients (of legal age) with indication for Power-PICC-Line catheter implantation will be randomly assigned to one of the two arms (fluoroscopy or SHERLOCK). Depending on randomization, the Power-PICC implantation occurs either under fluoroscopy or with the SHERLOCK system. All related substances, measures or procedures are performed according to the clinical routine. The medical device is a fully integrated magnetic tracking and ECG-based peripherally inserted central catheter (PICC) tip confirmation technology applied on patients with normal sinus rhythm and placed through a peripheral vein. The Sherlock system is CE-certified since December 2011.
The referral of patients with indication to PICC-Line implantation at the institute of diagnostic and interventional radiology occurs through different departments of the University Hospital Jena. The patients are registered for radiological treatment and checked again by a radiologist if a PICC-Line implantation is indicated. If this is the case, the radiologist conducts an informed consent discussion with the patient about possible complications and risks during intervention and informs him also about a possible study. After signature of the written informed consent, the patient is included. On the intervention day, the patient is randomly assigned to one of the two study arms through RandomTool (Sherlock vs. fluoroscopy). According to randomization group, the PICC catheter is implanted (duration: 30 minutes) and eventually a chest x-ray (fluoroscopy) is performed to assess safety and efficacy.The intervention time from puncture to catheter placement is documented. After intervention, the patient is transferred back to the ward or sent home in hemodynamically stable conditions. The examination of the puncture site before discharge is performed by a ward physician or by the family doctor. 24 h after PICC-Line implantation, the treating physician is contacted and questioned about possible complications (catheter occlusion, haematoma, infection of the puncture site, arm vein thrombosis, pain, etc.), that are then thoroughly documented.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoroscopy | Active comparator | Device: PICC implantation under fluoroscopyPICC Implantation under x-ray |
| Sherlock System (BARD) | Active comparator | Device: PICC Implantation under Sherlock SystemPICC Implantation with Integrated Magnetic Tracking and ECG-guided Tip Location System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female, male
- adults ≥ 18 years
- medical indication for Power-PICC-Line catheter implantation because of chemotherapy or parenertal nutrition
- in- and outpatients
Key exclusion criteria (5 listed)
- children and adolescents < 18 years
- systemic or local infection of the interventional location
- known allergy to used material
- general contraindication of Power-PICC-Line catheter implantation
- nonexistent sinus rhythm (5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICC implantation under fluoroscopyPICC Catheter implantation | Device | Fluoroscopy |
| PICC Implantation under Sherlock SystemPICC Catheter implantation | Device | Sherlock System (BARD) |
Primary outcome
Tip Placement efficiency measured by chest radiograph
Time frame: through study completion, an average of 2 years
Corect placement through anatomic evaluation of chest x-ray measuring catheter tip max. two vertebral bodies under carina
2 secondary outcomes
Safety measured by follow-up interview with referring physician and documentation of AE
Time frame: Follow-up within one week
Implantation time
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 32556606Mack V, Nissler D, Kasikci D, Malouhi A, Aschenbach R, Teichgraber U. Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System Versus Fluoroscopy for Placement of Peripherally Inserted Central Catheters: A Randomized, Noninferiority Comparison. Cardiovasc Intervent Radiol. 2020 Dec;43(12):1891-1897. doi: 10.1007/s00270-020-02551-0. Epub 2020 Jun 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heike Habrecht, Dr. med. principal investigator
Jena University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICC implantation under fluoroscopy and PICC Implantation under Sherlock System in people with Patients With PICC-Line, run by Jena University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tip Placement efficiency measured by chest radiograph (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02929368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.