Effectiveness and Safety of the Seldinger Wire Technique Using a 145 cm Guidewire With the Modified Seldinger Technique Using a 70 cm GuidewireOver-the-WireNCT04303052
Non-Inferiority Study to Compare the Effectiveness of the Seldinger Over-the-Wire Technique and the Modified Seldinger Technique
A study testing Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or and Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire) in people with Effectiveness and Safety of the Seldinger Wire Technique Using a 145 cm Guidewire With the Modified Seldinger Technique Using a 70 cm Guidewire, run by Jena University Hospital at 1 site in Germany.
Trial summary
Peripherally inserted central venous catheter lines (PICC-line) are successfully used since many years in patients who need long-term frequent IV therapy. The PICC placement is performed under fluoroscopy The study objective is to compare the effectiveness and safety of the Seldinger wire technique (over-the-wire)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effectiveness and Safety of the Seldinger Wire Technique Using a 145 cm Guidewire With the Modified Seldinger Technique Using a 70 cm Guidewire
- What is being tested?
- Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or and Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- 2 Feb 2018to 1 Oct 2019
- 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
- age < 18 years
- systemic infection
- local infection of the interventional location
- known allergy to used material
- general contraindication of Power-PICC-Line catheter implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized-Controlled Non-Inferiority Study to Compare the Effectiveness of the Seldinger Over-the-Wire Technique and the Modified Seldinger Technique
Peripherally inserted central venous catheter lines (PICC-line) are successfully used since many years in patients who need long-term frequent IV therapy. The PICC placement is performed under fluoroscopy The study objective is to compare the effectiveness and safety of the Seldinger wire technique (over-the-wire) using a 145 cm guidewire with the modified Seldinger technique using a 70 cm guidewire.
Read the detailed description
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 participation. After signature of the written informed consent, the patient is included. He can, at any time, withdraw his consent. On the intervention day, the patient is randomly assigned to one of the two study arms through envelope (145 cm vs 70 cm). The intervention time is documented. After intervention, the patient is transferred back to the ward or sent home. The examination of the puncture site before discharge is performed by a ward physician or by the family doctor.
Within 2 weeks 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.
- Being tested
- Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or, Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) orDevice
Before Power-PICC-line catheter implantation, the patients undergo an examination of the planned intervention site and ultrasound check, and analysis of the blood tests. An informed consent discussion and the patient's signature on the informed consent are obligatory. The length of the catheter and the optimal position of the catheter tip are verified by fluoroscopy. After catheter implantation, the tip location is verified by a final chest x-ray. The follow-up visit and the control of the puncture site until removal of the catheter are performed during hospitalization or subsequently by the treating family doctor.
Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)Device
Before Power-PICC-line catheter implantation, the patients undergo an examination of the planned intervention site and ultrasound check, and analysis of the blood tests. An informed consent discussion and the patient's signature on the informed consent are obligatory. The length of the catheter and the optimal position of the catheter tip are verified by fluoroscopy. After catheter implantation, the tip location is verified by a final chest x-ray. The follow-up visit and the control of the puncture site until removal of the catheter are performed during hospitalization or subsequently by the treating family doctor.
| Study group | Role | What they receive |
|---|---|---|
| over-the-wire technique with 145 cm guidewire | Active comparator | Catheter tip placement using Seldinger over-the-wire technique with 145 cm guidewire Receives: Device: Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or |
| modified technique with 70 cm guidewire | Active comparator | Catheter tip placement using Seldinger modified technique with 70 cm guidewire Receives: Device: Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation time
Economy of time until beginning of treatment
Measured: 24 hours
Secondary outcomes (1)
Placement accuracy of catheter tip compared to chest x-ray
by final chest X-ray
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start2 Feb 2018
- Primary completion28 Aug 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness and Safety of the Seldinger Wire Technique Using a 145 cm Guidewire With the Modified Seldinger Technique Using a 70 cm GuidewireStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Depending on randomization, the Power-PICC implantation occurs either with Seldinger over-the-wire technique or with Seldinger modified technique. All related substances, measures or procedures are performed according to the clinical routine.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heike Habrecht, Dr., Principal investigator, Institute of Diagnostic and Interventional Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303052
- Sponsor's protocol ID
- 5385-12/17
- Acronym
- Over-the-Wire
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Non-Inferiority Study to Compare the Effectiveness of the Seldinger Over-the-Wire Technique and the Modified Seldinger Technique
- ClinicalTrials.gov ID
- NCT04303052
- Acronym / sponsor ID
- Over-the-Wire / 5385-12/17
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 10 Mar 2020 (actual)
- 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 venous catheter lines (PICC-line) are successfully used since many years in patients who need long-term frequent IV therapy. The PICC placement is performed under fluoroscopy The study objective is to compare the effectiveness and safety of the Seldinger wire technique (over-the-wire) using a 145 cm guidewire with the modified Seldinger technique using a 70 cm guidewire.
Detailed description
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 participation. After signature of the written informed consent, the patient is included. He can, at any time, withdraw his consent. On the intervention day, the patient is randomly assigned to one of the two study arms through envelope (145 cm vs 70 cm). The intervention time is documented. After intervention, the patient is transferred back to the ward or sent home. The examination of the puncture site before discharge is performed by a ward physician or by the family doctor.
Within 2 weeks 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Depending on randomization, the Power-PICC implantation occurs either with Seldinger over-the-wire technique or with Seldinger modified technique. All related substances, measures or procedures are performed according to the clinical routine.
| Arm | Type | Receives |
|---|---|---|
| over-the-wire technique with 145 cm guidewire | Active comparator | Device: Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) orCatheter tip placement using Seldinger over-the-wire technique with 145 cm guidewire |
| modified technique with 70 cm guidewire | Active comparator | Device: Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)Catheter tip placement using Seldinger modified technique with 70 cm guidewire |
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)
- age < 18 years
- systemic infection
- local infection of the interventional location
- known allergy to used material
- general contraindication of Power-PICC-Line catheter implantation
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 |
|---|---|---|
| Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) orBefore Power-PICC-line catheter implantation, the patients undergo an examination of the planned intervention site and ultrasound check, and analysis of the blood tests. An informed consent discussion and the patient's signature on the informed consent are obligatory. The length of the catheter and the optimal position of the catheter tip are verified by fluoroscopy. After catheter implantation, the tip location is verified by a final chest x-ray. The follow-up visit and the control of the puncture site until removal of the catheter are performed during hospitalization or subsequently by the treating family doctor. | Device | over-the-wire technique with 145 cm guidewire |
| Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)Before Power-PICC-line catheter implantation, the patients undergo an examination of the planned intervention site and ultrasound check, and analysis of the blood tests. An informed consent discussion and the patient's signature on the informed consent are obligatory. The length of the catheter and the optimal position of the catheter tip are verified by fluoroscopy. After catheter implantation, the tip location is verified by a final chest x-ray. The follow-up visit and the control of the puncture site until removal of the catheter are performed during hospitalization or subsequently by the treating family doctor. | Device | modified technique with 70 cm guidewire |
Primary outcome
Implantation time
Time frame: 24 hours
Economy of time until beginning of treatment
1 secondary outcome
Placement accuracy of catheter tip compared to chest x-ray
Time frame: 24 hours
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.
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. principal investigator
Institute of Diagnostic and Interventional Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or and Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire) in people with Effectiveness and Safety of the Seldinger Wire Technique Using a 145 cm Guidewire With the Modified Seldinger Technique Using a 70 cm Guidewire, 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?
Implantation time (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.