Venous Insufficiency of LegeSCOPENCT01570101
European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study
A study testing CE Marked Sapheon Closure System in people with Venous Insufficiency of Leg, run by Medtronic Endovascular at 7 sites in 4 countries.
Trial summary
The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Venous Insufficiency of Leg
- What is being tested?
- CE Marked Sapheon Closure System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Dec 2011to Sep 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤ 70 years of age.
- Symptomatic primary Great Saphenous Vein "GSV" incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
- CEAP classification of C2, C3 or C4.
- Ability to walk unassisted.
- Ability to attend follow-up visits.
- Ability to understand the requirements of the study and to provide written informed consent.
- "GSV" on standing pre-procedure Doppler Ultrasound ≥3mm and ≤10mm (maximum diameter).
Who cannot join
- Life expectancy < 1 year.
- Regular pain medication.
- Anticoagulation including Heparin or Coumadin.
- Previous Deep Vein Thrombosis "DVT".
- Previous superficial thrombophlebitis in "GSV".
- Previous venous treatment on target limb.
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- Known Hyper-coagulable disorder.
- Conditions which prevent routine vein treatment like:
- Acute disease,
- Immobilization or inability to ambulate, and
- Pregnancy.
- Tortuous "GSV", which in the opinion of the Investigator will limit catheter placement. (no 2 primary access sites allowed).
- Incompetent ipsilateral small saphenous or anterior accessory great saphenous vein.
- Known sensitivity to the cyanoacrylate "CA" adhesive.
- Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United Kingdom3 sites
Countess of Chester Hospital NHS Foundation Trust
Chester, CH2 1UL
The Whiteley Clinic
Guildford, GU2 7RF
Charing Cross Hospital
London, W6 8RF
Germany2 sites
Dermatologikum
Hamburg, 20354
Klinik Proebstle
Mannheim, D - 68161
About this study
Official title: Post Market Study - "European Observational Study of the Sapheon™ Closure System for the Definitive Treatment of Incompetent Great Saphenous Veins: A Prospective Single Arm Multicenter Clinical Observational Study"
The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
Read the detailed description
This is a post market, observational study of closure of the great saphenous vein "GSV". Efficacy and safety (adverse events) will be compared to appropriate literature reports to determine if the results of the treatment of reflux disease with the Sapheon Closure System are consistent with or better than the expectations of the medical community for alternative treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation. Additional comparison points may include measurements of pain and/or length of time to return to work.
- Conditions
- Venous Insufficiency of Leg
- Being tested
- CE Marked Sapheon Closure System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE Marked Sapheon Closure SystemDevice
CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
| Study group | Role | What they receive |
|---|---|---|
| CE Marked Sapheon Closure System in GSV | Experimental | CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting. Receives: Device: CE Marked Sapheon Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative Duplex Ultrasound
The Primary endpoint is a change in duplex ultrasound immediately post-procedure as compared to the pre-procedure duplex ultrasound, proving great saphenous vein closure with lack of pathological reflux.
Measured: Immediately Post-procedure
Secondary outcomes (1)
Safety
The Secondary endpoint is safety, reflected by the rate of occurrence of all adverse events (procedure and non-procedure related; serious and non-serious).
Measured: Immediately post-op through 6 month Follow-up "FU"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous Insufficiency of LegStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Proebstle, MD, Principal investigator, Klinik Proebstlé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570101
- Sponsor's protocol ID
- CP-10763-01
- Acronym
- eSCOPE
- Status last verified
- Apr 2016
- First submitted
- 26 Mar 2012
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Proebstle T, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Davies AH. Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2021 Mar;9(2):329-334. doi: 10.1016/j.jvsv.2020.05.019. Epub 2020 Jun 26.
PubMed 32599306Proebstle TM, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Cher D, Davies A. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):2-7. doi: 10.1016/j.jvsv.2014.09.001. Epub 2014 Oct 18.
PubMed 26993674
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Study - "European Observational Study of the Sapheon™ Closure System for the Definitive Treatment of Incompetent Great Saphenous Veins: A Prospective Single Arm Multicenter Clinical Observational Study"
- ClinicalTrials.gov ID
- NCT01570101
- Acronym / sponsor ID
- eSCOPE / CP-10763-01
- Conditions
- Venous Insufficiency of Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Apr 2012 (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.
The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
Detailed description
This is a post market, observational study of closure of the great saphenous vein "GSV". Efficacy and safety (adverse events) will be compared to appropriate literature reports to determine if the results of the treatment of reflux disease with the Sapheon Closure System are consistent with or better than the expectations of the medical community for alternative treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation. Additional comparison points may include measurements of pain and/or length of time to return to work.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CE Marked Sapheon Closure System in GSV | Experimental | Device: CE Marked Sapheon Closure SystemCE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years and ≤ 70 years of age.
- Symptomatic primary Great Saphenous Vein "GSV" incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
- CEAP classification of C2, C3 or C4.
- Ability to walk unassisted.
- Ability to attend follow-up visits.
Key exclusion criteria (15 listed)
- Life expectancy < 1 year.
- Regular pain medication.
- Anticoagulation including Heparin or Coumadin.
- Previous Deep Vein Thrombosis "DVT".
- Previous superficial thrombophlebitis in "GSV".
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 |
|---|---|---|
| CE Marked Sapheon Closure SystemCE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting. | Device | CE Marked Sapheon Closure System in GSV |
Primary outcome
Comparative Duplex Ultrasound
Time frame: Immediately Post-procedure
The Primary endpoint is a change in duplex ultrasound immediately post-procedure as compared to the pre-procedure duplex ultrasound, proving great saphenous vein closure with lack of pathological reflux.
1 secondary outcome
Safety
Time frame: Immediately post-op through 6 month Follow-up "FU"
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 3 May 2016.
- Derived from this study: PubMed 32599306Proebstle T, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Davies AH. Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2021 Mar;9(2):329-334. doi: 10.1016/j.jvsv.2020.05.019. Epub 2020 Jun 26.
- Derived from this study: PubMed 26993674Proebstle TM, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Cher D, Davies A. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):2-7. doi: 10.1016/j.jvsv.2014.09.001. Epub 2014 Oct 18.
- 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.
Thomas Proebstle, MD principal investigator
Klinik Proebstlé
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CE Marked Sapheon Closure System in people with Venous Insufficiency of Leg, run by Medtronic Endovascular at 7 sites in 4 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 7 inclusion and 15 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 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, Germany, Denmark, Netherlands. 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?
Comparative Duplex Ultrasound (time frame: Immediately Post-procedure). 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 NCT01570101, which also lists 2 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 3 May 2016.