5.1 Study ObjectivesThe primary objective for this clinical observational study is to assess the role of the Sapheon Closure System in closure of incompetent great saphenous veins in a routine clinical setting.5.2 Study HypothesisThis is an…
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Brief title
Condition
- Venous varices
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Research involving
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Intervention
Outcome measures
Primary outcome
This is an observational study on an approved device. Efficacy and safety
(adverse events) will be compared with appropriate literature reports to
determine if the results of the treatment of reflux disease with the Sapheon
Closure System (SCS) Kit are consistent with or not inferior than the
expectations of the medical community for alternative treatments, specifically
Laser Thermal Ablation and Radiofrequency Ablation.
* The Primary endpoint is duplex ultrasound proven great saphenous vein closure
with lack of pathological reflux at prescribed intervals.
Efficacy: The ability of the Sapheon Closure System (SCS) Kit to treat venous
reflux by closing the great saphenous vein.
During the procedure, the primary measures are defined as follows:
* Procedural Success (complete closure) * vein closure along the entire treated
vein segment due to the initial Sapheon Closure System directed administration
of the Sapheon Closure Adhesive (SCA). No discrete segments of patency * 10cm.
* Procedural Failure * inability to attain vein closure during the procedure
with discrete segments of patency > 10 cm.
At all follow-up, the primary efficacy measures are:
* Complete Closure * Duplex ultrasound proven vein closure along the entire
treated vein segment due to the initial Sapheon Closure System directed
administration of the Sapheon Closure Adhesive (SCA). No discrete segments of
patency * 10cm.
* Recanalization/Patency * significant recanalization/patency in a treated vein
that was previously closed or partially closed, or was an initial procedural
failure and has discrete segments of >10cm of patency
Secondary outcome
7.2 Secondary Endpoints
* The Secondary endpoint is safety, reflected by the rate of occurrence of all
adverse events (procedure and non-procedure related; serious and non-serious).
Safety: Evaluation of safety will be accomplished by carefully monitoring and
recording the incidence of adverse events during the procedure, immediately
after the procedure, and during a 6-month follow-up period which includes
follow-up visits 24-72 hours, and 1, 3, and 6 months post procedure.
7.3 Third Endpoint
Quality of life and pain
* Patient satisfaction and Quality of Life measured by EQ5D, AVVQ and Adverse
reactions, at prescribed time periods pre- and post-procedure (see Table 1).
* Venous Clinical Severity Score at prescribed time periods pre- and
post-procedure (see Table 1).
* Pain during the procedure, diary (VAS) on use of analgesics, at proscribed
time periods pre- and post-procedure (see Table 1). Pain reported during the
first 30 days by patient diary VAS.
Background summary
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 lower extremity venous system consists of the
superficial system (e.g. great and small saphenous veins and saphenous
tributaries) and the deep system (e.g. femoral and popliteal veins). Reflux due
to incompetent valves in the superficial venous system is the most common form
of venous insufficiency, and may or may not have associated symptoms. In most
patients however, varicose veins with symptoms such as heavy, burning, itchy,
aching or painful legs are reported. In addition, varicose veins may be
complicated by edema, thrombophlebitis, venous ulceration and chronic skin
changes.1,2
The ultimate goal of any treatment regimen is to eliminate sources of reflux in
order to control the progression of the disease, improve symptoms, promote
ulcer healing, and prevent recurrence or a combination of these. The best
therapeutic results are based on two hemodynamic principles: the abolishment of
the highest point of reflux and the elimination of the incompetent and dilated
venous segments.
Closing the great saphenous vein (GSV) is a recognized procedure in reducing
the effects of venous valvular insufficiency. Traditionally, this has been
accomplished by surgical ligation and stripping. Although this technique
resulted in a durable treatment, it also resulted in significant perioperative
morbidity.2,3 More recently endovenous methods have been used. These
techniques use thermal ablation with laser or radiofrequency heating.3 Some of
the challenges with the thermal ablation methods include complications related
to the thermal injury of the treated vessel and surrounding tissue, which may
result in skin burns, injury to the saphenous nerve or thrombotic and
inflammatory events.1Sapheon, Inc. has developed a novel system for closing the
GSV with an endovenous technique, using a catheter system for access and a
dispensing unit for application of a cyanoacrylate tissue adhesive for closure
of the GSV.
Tissue adhesives represent a group of compounds that can be applied locally for
a variety of indications, including hemostasis, wound closure, and fistula
repair. The main classes of tissue adhesives currently utilized in surgery
include cyanoacrylates, fibrin glues, and thrombin. Cyanoacrylates are used
widely outside of the United States and in the United States as tissue
adhesive, a vascular closure agent, and as an intracranial embolic agent for
arteriovascular malformations.
Cyanoacrylates are synthetic glues that rapidly polymerize on contact with
water or blood. N-butyl-2-cyanoacrylate (Histoacryl; B Braun, Melsungen,
Germany) has been used extensively in surgery for the last 10 years. Another
N-butyl-2-cyanoacrylate (Glubran; GEM S.r.l., Viareggio, Italy) was recently
approved for endoscopic use in Europe. 2-Octyl-cyanoacrylate (Dermabond;
Ethicon, Inc., Somerville, NJ), approved by the Federal Drug Administration for
superficial wound closure, is widely used by emergency room physicians,
dermatologists, and plastic surgeons.
It is expected that GSV closure for the treatment of incompetent saphenous
veins with the Sapheon Closure System will have comparable or better procedure
safety and effectiveness, but be less painful than other treatments, and
require a shorter recovery period.
Study objective
5.1 Study Objectives
The primary objective for this clinical observational study is to assess the
role of the Sapheon Closure System in closure of incompetent great saphenous
veins in a routine clinical setting.
5.2 Study Hypothesis
This is an observational study on routine intervention for abolishing GSV
reflux. 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
This is an international, multi-center, prospective, single arm, observational,
post-market release study designed to record the clinical outcomes of the CE
marked Sapheon Closure System for its CE marked approved indications. Subjects
who meet the eligibility criteria will be enrolled sequentially. No control
arm will be used since efficacy will be determined using the subjects*
pre-treatment status as an internal control.
Study burden and risks
Risks include those normally expected for standard vein surgery. Complications
are generally rare, not severe, and may require additional procedures to
correct.
Following the procedure, subjects will be followed for at least 6 months (and
up to 36 months). A total of 7 regular follow-up visits will occur at the
following time points: 24-72 hours post-procedure, 30 days post-procedure, 3
months post-procedure, 6 months, 12 months, 24 months, and 36 months
post-procedure. Additional visits will be scheduled if deemed appropriate in
the judgment of the Investigator
3579 Westwind Blvd
Santa Rosa California 95403
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3579 Westwind Blvd
Santa Rosa California 95403
US
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Age
Inclusion criteria
* Age *18 years and * 70 years of age.
* Symptomatic primary GSV incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
* CEAP classification of C2, C3 or C4 (see Appendix 10).
* 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 US *3mm and *10mm (maximum diameter).
Exclusion criteria
* Life expectancy < 1 year.
* Regular pain medication.
* Anticoagulation including Heparin or Coumadin.
* Previous DVT.
* Previous superficial thrombophlebitis in GSV.
* Previous venous treatment on target limb.
* Known Hyper-coagulable disorder.
* Conditions which prevent routine vein treatment like:
o Acute disease,
o Immobilization or inability to ambulate, and
o 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38844.094.12 |