Chronic Venous ThrombosisSAVENCT02875899
Surfacer System to Facilitate Access in Venous Occlusions
An observational study of Chronic Venous Thrombosis and Venous Thrombosis Upper Extremity, run by Merit Medical Systems, Inc. at 4 sites in 3 countries.
Trial summary
Prospective, single-arm, multicentre, international Registry of the Surfacer System for the treatment of patients with limited or diminishing upper body venous access or pathology impeding standard access methods.The purpose of this post-market Registry is to assess the standard of care and clinical outcomes of the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Venous Thrombosis, Venous Thrombosis Upper Extremity, Venous Thrombosis Upper Extremity Superficial Veins
- How many people
- 30 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 7 Feb 2017to 4 Oct 2018
- How long will I take part?
- 14 Days
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients requiring central venous access for: * dialysis * chemotherapy nutrition * delivery of any pharmacological therapy
Who may be able to join
None listed.
Who cannot join
- vulnerable subjects or incapable of giving consent
- contraindications to central venous access based on treating physicians opinion or standard of care
- occlusion of the right femoral vein
- occlusion of the iliac vein
- occlusion of the inferior vena
- acute thrombosis within a vessel (IVC, brachiocephalic and subclavian)
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
University Hospital of Cologne
Cologne, D-50937
Schon Klinik
Düsseldorf, 40549
About this study
Prospective, single-arm, multicentre, international Registry of the Surfacer System for the treatment of patients with limited or diminishing upper body venous access or pathology impeding standard access methods.The purpose of this post-market Registry is to assess the standard of care and clinical outcomes of the Surfacer System used in clinical routine according to the approved commercial indications.
Read the detailed description
This is a prospective, single-arm, multicenter registry of the Surfacer System for patients with limited or diminishing upper body venous access or pathology impeding standard access methods. The need for long term access and lack of availability of veins has led to the development of the Surfacer System, which facilitates reliable and repeatable placement of central venous catheters and restores central venous access. Based on European legislation, this Registry is considered to be an observational study. No additional diagnostic or monitoring procedures as a result of the inclusion are applied to the patients. Available data will be collected in a protected database. Up to 30 patients will be enrolled in 5 sites in Europe. Patients requiring central venous access will be enrolled who meet inclusion and exclusion criteria and for whom the device is indicated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of all acute safety and device related serious adverse event recorded on case report forms
overall complication rate compared to safety data
Measured: Procedure through discharge at 24 hours post procedure. Data will be presented through study completion, 1 year.
Secondary outcomes (3)
Ability to place central venous access catheter using Surfacer system
performance evaluated by procedure time measured by time to create access
Measured: Procedure
Surfacer system advancement of the exit wire outside the vein
Ability to advance system from femoral vein to supraclavicular exit as measured by time
Measured: procedure
Insertion of a standard central venous access catheter to deliver fluid or pharmacological agents
introducing a standard central venous access catheter over the needle wire
Measured: procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start7 Feb 2017
- Primary completion20 Sep 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous ThrombosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Minarsch, RT, Study director, Bluegrass Vascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875899
- Sponsor's protocol ID
- CP0002
- Acronym
- SAVE
- Status last verified
- Jan 2024
- First submitted
- 12 Aug 2016
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Elayi CS, Allen CL, Leung S, Lusher S, Morales GX, Wiisanen M, Aikat S, Kakavand B, Shah JS, Moliterno DJ, Gurley JC. Inside-out access: a new method of lead placement for patients with central venous occlusions. Heart Rhythm. 2011 Jun;8(6):851-7. doi: 10.1016/j.hrthm.2011.01.024. Epub 2011 Jan 13.
PubMed 21237290Frykholm P, Pikwer A, Hammarskjold F, Larsson AT, Lindgren S, Lindwall R, Taxbro K, Oberg F, Acosta S, Akeson J. Clinical guidelines on central venous catheterisation. Swedish Society of Anaesthesiology and Intensive Care Medicine. Acta Anaesthesiol Scand. 2014 May;58(5):508-24. doi: 10.1111/aas.12295. Epub 2014 Mar 5.
PubMed 24593804Baskin JL, Pui CH, Reiss U, Wilimas JA, Metzger ML, Ribeiro RC, Howard SC. Management of occlusion and thrombosis associated with long-term indwelling central venous catheters. Lancet. 2009 Jul 11;374(9684):159-69. doi: 10.1016/S0140-6736(09)60220-8.
PubMed 19595350
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surfacer System to Facilitate Access in Venous Occlusions
- ClinicalTrials.gov ID
- NCT02875899
- Acronym / sponsor ID
- SAVE / CP0002
- Conditions
- Chronic Venous Thrombosis, Venous Thrombosis Upper Extremity, Venous Thrombosis Upper Extremity Superficial Veins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 23 Aug 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.
Prospective, single-arm, multicentre, international Registry of the Surfacer System for the treatment of patients with limited or diminishing upper body venous access or pathology impeding standard access methods.The purpose of this post-market Registry is to assess the standard of care and clinical outcomes of the Surfacer System used in clinical routine according to the approved commercial indications.
Detailed description
This is a prospective, single-arm, multicenter registry of the Surfacer System for patients with limited or diminishing upper body venous access or pathology impeding standard access methods. The need for long term access and lack of availability of veins has led to the development of the Surfacer System, which facilitates reliable and repeatable placement of central venous catheters and restores central venous access. Based on European legislation, this Registry is considered to be an observational study. No additional diagnostic or monitoring procedures as a result of the inclusion are applied to the patients. Available data will be collected in a protected database. Up to 30 patients will be enrolled in 5 sites in Europe. Patients requiring central venous access will be enrolled who meet inclusion and exclusion criteria and for whom the device is indicated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients requiring central venous access for: * dialysis * chemotherapy nutrition * delivery of any pharmacological therapy
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- vulnerable subjects or incapable of giving consent
- contraindications to central venous access based on treating physicians opinion or standard of care
- occlusion of the right femoral vein
- occlusion of the iliac vein
- occlusion of the inferior vena
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absence of all acute safety and device related serious adverse event recorded on case report forms
Time frame: Procedure through discharge at 24 hours post procedure. Data will be presented through study completion, 1 year.
overall complication rate compared to safety data
3 secondary outcomes
Ability to place central venous access catheter using Surfacer system
Time frame: Procedure
Surfacer system advancement of the exit wire outside the vein
Time frame: procedure
Insertion of a standard central venous access catheter to deliver fluid or pharmacological agents
Time frame: procedure
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 26 Jan 2024.
- Background: PubMed 21237290Elayi CS, Allen CL, Leung S, Lusher S, Morales GX, Wiisanen M, Aikat S, Kakavand B, Shah JS, Moliterno DJ, Gurley JC. Inside-out access: a new method of lead placement for patients with central venous occlusions. Heart Rhythm. 2011 Jun;8(6):851-7. doi: 10.1016/j.hrthm.2011.01.024. Epub 2011 Jan 13.
- Background: PubMed 24593804Frykholm P, Pikwer A, Hammarskjold F, Larsson AT, Lindgren S, Lindwall R, Taxbro K, Oberg F, Acosta S, Akeson J. Clinical guidelines on central venous catheterisation. Swedish Society of Anaesthesiology and Intensive Care Medicine. Acta Anaesthesiol Scand. 2014 May;58(5):508-24. doi: 10.1111/aas.12295. Epub 2014 Mar 5.
- Background: PubMed 19595350Baskin JL, Pui CH, Reiss U, Wilimas JA, Metzger ML, Ribeiro RC, Howard SC. Management of occlusion and thrombosis associated with long-term indwelling central venous catheters. Lancet. 2009 Jul 11;374(9684):159-69. doi: 10.1016/S0140-6736(09)60220-8.
- Individual participant dataSharing planned: Undecided
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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.
Laura Minarsch, RT study director
Bluegrass Vascular
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Thrombosis and Venous Thrombosis Upper Extremity, run by Merit Medical Systems, Inc. at 4 sites in 3 countries.
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 0 inclusion and 6 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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria, Italy. 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?
Absence of all acute safety and device related serious adverse event recorded on case report forms (time frame: Procedure through discharge at 24 hours post procedure. Data will be presented through study completion, 1 year.). 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 NCT02875899, which also lists 3 linked publications.
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 26 Jan 2024.