Venous Insufficiency of LegNCT01603433
The Sapheon Closure System Feasibility Study
A study testing Sapheon™ Closure System in people with Venous Insufficiency of Leg, run by Medtronic Endovascular at 1 site in Dominican Republic.
Trial summary
This is a single center, prospective, non-randomized, feasibility study for the evaluation of safety, efficacy and performance of the Sapheon™ Closure System for the treatment of incompetent saphenous veins. Read more about this study
- Who is it for?
- Ages 21 to 76 years
- Conditions the study is for
- Venous Insufficiency of Leg
- What is being tested?
- Sapheon™ Closure System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteDominican Republic
- Study dates
- Jul 2011to Jul 2014
- 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 21 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or non-pregnant females ≥21 years of age but <76 years of age.
- Venous reflux disease in the GSV diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
- Candidate for surgical closure of a segment of the GSV.
- CEAP classification of C2, C3 or C4.
- Ability to walk unassisted.
- Life expectancy of at least 18 months.
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- Weight >110 lbs. (50 kg).
- Ability to attend follow-up visits.
- Ability to understand the investigational nature of the treatment, and to provide written informed consent.
Who cannot join
- Previous surgical procedure (surgical, thermal, or chemical ablation) associated with the venous segment to be treated.
- Diameter of index vein (Supine) <3mm or >12 mm in any segment.
- Tortuous GSV, which in the opinion of the Investigator will limit catheter placement.
- Local or systemic infection.
- Insulin dependent diabetes.
- Leg obesity impairing the ability to gain access to the treatment leg, and/or apply sufficient compression for treatment.
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- Documented history of superficial or deep thrombophlebitis.
- Varicosities secondary to pelvic or abdominal tumor.
- Significant arterial insufficiency; demonstrated by absence of ankle pulse.
- Known sensitivity to the cyanoacrylate (CA) adhesive or positive reaction just prior to surgery (by injecting a small peripheral vein with the agent). The Study surgeon will judge the need for the injection and the subject's reaction to the injection on clinical grounds.
- Formal duplication of the saphenous trunk in the index vein (Accessory GSV segments allowed).
- Hypercoaguable state.
- Presence of incompetent perforators in the treatment length.
- History of right ventricular failure.
- Significant femoral or popliteal vein insufficiency.
- BMI >35
- Additional procedures in the treatment leg likely required within the six months after the investigational procedure.
- Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
- Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the Investigator may prevent safe participation or otherwise render the subject ineligible for the Study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single center, prospective, non-randomized, feasibility study for the evaluation of safety, efficacy and performance of the Sapheon™ Closure System for the treatment of incompetent saphenous veins.
Read the detailed description
Venous insufficiency of the lower extremities is a very common condition that is influenced by genetic and mechanical factors, and is a chronic and progressive disorder. The primary objectives for this clinical Study are to
- demonstrate the safety of the Sapheon™ Closure System for the treatment of incompetent saphenous veins,
- demonstrate the early and late efficacy of The Sapheon™ Closure System for the treatment of incompetent saphenous veins, and
- demonstrate the satisfactory performance of the Sapheon™ Closure System device components.
- Conditions
- Venous Insufficiency of Leg
- Being tested
- Sapheon™ Closure System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sapheon™ Closure SystemDevice
Sapheon™ Closure System for the treatment of incompetent saphenous veins.
| Study group | Role | What they receive |
|---|---|---|
| Sapheon™ Closure System | Experimental | Sapheon™ Closure System for the treatment of incompetent saphenous veins. Receives: Device: Sapheon™ Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical Success
Evaluation of anatomic efficacy will be demonstrated by the absence of flow (Complete Closure) within the treated vein segment as determined by duplex ultrasound examination and will be performed in accordance with a standardized and detailed imaging protocol.
Measured: 30 days post procedure
Secondary outcomes (1)
Safety Endpoint
Evaluation of safety will be assessed by the DSMB of all incidence of adverse events (procedure and non-procedure related; serious and non-serious)
Measured: Through 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2014
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 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudia Bautista, MD, Principal investigator, Clinica Canela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603433
- Sponsor's protocol ID
- CP-10669-01
- Status last verified
- Apr 2016
- First submitted
- 18 May 2012
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology. 2015 Jul;30(6):397-404. doi: 10.1177/0268355514532455. Epub 2014 Apr 30.
PubMed 24789750
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
- The Sapheon Closure System Feasibility Study
- ClinicalTrials.gov ID
- NCT01603433
- Acronym / sponsor ID
- CP-10669-01
- Conditions
- Venous Insufficiency of Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 May 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.
This is a single center, prospective, non-randomized, feasibility study for the evaluation of safety, efficacy and performance of the Sapheon™ Closure System for the treatment of incompetent saphenous veins.
Detailed description
Venous insufficiency of the lower extremities is a very common condition that is influenced by genetic and mechanical factors, and is a chronic and progressive disorder. The primary objectives for this clinical Study are to
- demonstrate the safety of the Sapheon™ Closure System for the treatment of incompetent saphenous veins,
- demonstrate the early and late efficacy of The Sapheon™ Closure System for the treatment of incompetent saphenous veins, and
- demonstrate the satisfactory performance of the Sapheon™ Closure System device components.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sapheon™ Closure System | Experimental | Device: Sapheon™ Closure SystemSapheon™ Closure System for the treatment of incompetent saphenous veins. |
Who may qualify
- Ages
- 21 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or non-pregnant females ≥21 years of age but <76 years of age.
- Venous reflux disease in the GSV diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
- Candidate for surgical closure of a segment of the GSV.
- CEAP classification of C2, C3 or C4.
- Ability to walk unassisted.
Key exclusion criteria (19 listed)
- Previous surgical procedure (surgical, thermal, or chemical ablation) associated with the venous segment to be treated.
- Diameter of index vein (Supine) <3mm or >12 mm in any segment.
- Tortuous GSV, which in the opinion of the Investigator will limit catheter placement.
- Local or systemic infection.
- Insulin dependent diabetes.
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 |
|---|---|---|
| Sapheon™ Closure SystemSapheon™ Closure System for the treatment of incompetent saphenous veins. | Device | Sapheon™ Closure System |
Primary outcome
Anatomical Success
Time frame: 30 days post procedure
Evaluation of anatomic efficacy will be demonstrated by the absence of flow (Complete Closure) within the treated vein segment as determined by duplex ultrasound examination and will be performed in accordance with a standardized and detailed imaging protocol.
1 secondary outcome
Safety Endpoint
Time frame: Through 6 month follow-up
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 24789750Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology. 2015 Jul;30(6):397-404. doi: 10.1177/0268355514532455. Epub 2014 Apr 30.
- 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.
Claudia Bautista, MD principal investigator
Clinica Canela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sapheon™ Closure System in people with Venous Insufficiency of Leg, run by Medtronic Endovascular at 1 site in Dominican Republic.
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 9 inclusion and 19 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 1 site in Dominican Republic. 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?
Anatomical Success (time frame: 30 days 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 NCT01603433, 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 3 May 2016.