Randomized Studies (CEAP 2-5): To evaluate the patient*s experience and clinical improvement after treatment with the VenaSeal* system compared to standard of care treatments, surgical stripping or ETA, in the treatment of symptomatic superficial…
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Source
Brief title
Condition
- Venous varices
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the CEAP 2-5 Randomized Studies, the primary objectives are to compare the
VenaSeal* system to surgical stripping and ETA regarding patient experience and
satisfaction, through a validated, patient-centered 2-part venous treatment
satisfaction questionnaire (VenousTSQ-early [VenousTSQe] and VenousTSQ-status
[VenousTSQs]) at 30 days, and the ability to achieve elimination of clinically
relevant superficial truncal disease in the target veins at the index
procedure.
For the VLU Study, the primary objective is to evaluate time to ulcer healing
through 12 months.
Primary Endpoints
The CEAP 2-5 Randomized Studies have three primary endpoints comparing the
VenaSeal* system to surgical stripping or ETA.
1.Peri-procedural patient satisfaction as measured by a validated,
patient-centered venous treatment satisfaction questionnaire (VenousTSQe) at 30
days.
2.Patient satisfaction as measured by a validated, patient-centered venous
treatment satisfaction questionnaire (VenousTSQs) at 30 days.
3.Elimination of clinically relevant superficial truncal disease in each target
vein at the time of index procedure as measured by the percentage of target
vein length successfully treated.
The primary endpoint for the VLU Study is time to ulcer healing, calculated
through healing confirmation and verified by an independent core laboratory
through 12 months.
Secondary outcome
The key secondary objectives are to compare the VenaSeal* system to surgical
stripping and ETA in achieving the anatomical closure of superficial truncal
veins at 6 months, and the ability to return to work post-index procedure.
The secondary objective of the study is to evaluate the VenaSeal* system in the
treatment of symptomatic venous reflux in the superficial truncal veins.
Specific areas of analysis include: effectiveness, safety, healthcare
utilization, patient experience, and treating physician experience.
In addition, secondary objectives in the VLU Study include ulcer healing rate,
ulcer recurrence, and ulcer-free time.
Data supporting the following endpoints will be collected for both the CEAP 2-5
Randomized Studies as well as the VLU Study. When appropriate, data will be
evaluated for the CEAP 2-5 Randomized Studies to compare the VenaSeal* system
to surgical stripping or ETA. Data may also be pooled for all VenaSeal* system
subjects from the CEAP 2-5 Randomized Studies and VLU Study as appropriate.
Data from VenaSeal vs. Surgical Stripping Study will be collected through the
12 months visit.
Effectiveness secondary endpoints
Data supporting the following endpoints will be collected for both the CEAP 2-5
Randomized Studies as well as the VLU Study. When appropriate, data will be
evaluated for the CEAP 2-5 Randomized Studies to compare the VenaSeal* system
to surgical stripping or ETA. Data may also be pooled for all VenaSeal* system
subjects from the CEAP 2-5 Randomized Studies and VLU Study as appropriate.
Data from VenaSeal vs. Surgical Stripping Study will be collected through the
12 months visit.
Effectiveness secondary endpoints
Data supporting the following endpoints will be collected for both the CEAP 2-5
Randomized Studies as well as the VLU Study. When appropriate, data will be
evaluated for the CEAP 2-5 Randomized Studies to compare the VenaSeal* system
to surgical stripping or ETA. Data may also be pooled for all VenaSeal* system
subjects from the CEAP 2-5 Randomized Studies and VLU Study as appropriate.
Data from VenaSeal vs. Surgical Stripping Study will be collected through the
12 months visit.
Effectiveness secondary endpoints
1.Anatomic closure of primary target vein at 30 days, and 12, 24, 36, 48 and 60
months:
•For subjects treated with the VenaSeal* system or ETA it is defined as DUS
showing vein closure along the entire treated vein segment with no
discrete segments of patency exceeding 5 cm.
• For subjects treated with surgical stripping this is defined as absence of
refluxing or residual vein at 30 days and 12 months only.
2.Anatomic closure of target vein at 30 days, and 6, 12, 24, 36, 48 and 60
months:
•For subjects treated with the VenaSeal* system or ETA this is defined as DUS
showing vein closure along the entire treated vein segment with no
discrete segments of patency exceeding 5 cm.
•For subjects treated with surgical stripping this is defined as absence of
refluxing or residual vein at 30 days, 6 and 12 months only.
3.Fechnical success of each target vein immediately post-index procedure :
•For subjects treated with the VenaSeal* system or ETA this is defined as DUS
showing vein closure along the entire treated vein segment with no
discrete segments of patency exceeding 5 cm.
•For subjects treated with surgical stripping this is defined as absence of
refluxing or residual vein.
4.Reintervention of any target vein (including primary target vein) through 60
months, assessed at each follow-up visit. Subjects enrolled in the
VenaSeal vs. Surgical Stripping Study will be followed through the 12 months
visit only.
5.Time to reintervention of any target vein (including primary target vein)
through 60 months, as measured by the time between the index procedure
and the first reintervention procedure. Subjects enrolled in the VenaSeal
vs. Surgical Stripping Study will be followed through the 12 months visit
only.
Background summary
Please see protocol page 24 section 4.1 for the extensive background of the
study
Study objective
Randomized Studies (CEAP 2-5): To evaluate the patient*s experience and
clinical improvement after treatment with the VenaSeal* system compared to
standard of care treatments, surgical stripping or ETA, in the treatment of
symptomatic superficial venous disease (CEAP 2-5). Patient-centered outcomes,
vein closure, ability to return to work, and clinical improvement will be
measured after treatment of symptomatic venous reflux in the superficial
truncal veins by the VenaSeal* system or the comparator
treatments.Additionally, in a separate single-arm study, CEAP 6 patients with
at least one active venous leg ulcer will be enrolled, treated with the
VenaSeal* system and evaluated for wound healing. This study will complement
the available clinical evidence for the VenaSeal* system
There will be up to approximately 500 subjects enrolled in the VenaSeal
Spectrum Study. Approximately 375 subjects will be enrolled in CEAP clinical
classifications 2-5 in the Randomized Studies (108 subjects in VenaSeal vs.
Surgical Stripping Study and about 264 subjects in VenaSeal vs. ETA Study) ),
and up to 125 CEAP 6 subjects with will be treated with the VenaSeal* system.
Enrollment of the VenaSeal vs. Surgical Stripping Study was closed on
22-Feb-2022. All subjects participating in the VenaSeal vs ETA Study or in the
VLU Study (CEAP 2-6) will be followed up to 60
months post-index procedure, all subjects participating in the VenaSeal vs.
Surgical Stripping Study will be followed up to 12 months post-index procedure.
VLU Study (CEAP 6): To evaluate the patient*s experience and clinical
improvement after treatment with the VenaSeal* system in the treatment of
active venous leg ulcer (VLU) (CEAP 6) subjects.
Study design
Global, post-market, prospective, multi-center randomized controlled trial of
patients with symptomatic superficial venous disease, with a single arm
embedded ulcer subgroup.
There will be approximately 500 subjects enrolled in the VenaSeal Spectrum
Study. Approximately 375 subjects will be enrolled in CEAP clinical
classifications 2-5 in the Randomized Studies (108 subjects in VenaSeal vs.
Surgical Stripping Study and about 264 subjects in VenaSeal vs. ETA Study), and
up to 125 CEAP 6 subjects with (VLUs) will be treated with the VenaSeal*
system.Enrollment of the VenaSeal vs. Surgical Stripping Study was closed on
22-Feb-2022.
Intervention
Please see protocol section 10, from pg 51-80
Study burden and risks
Regarding study participation, subjects are not put at any additional risk for
participating in the study, as compared to being treated with the VenaSeal*
system, through ETA, or a surgical stripping treatment as part of their routine
care. Subjects for whom it is unethical to be randomized to one of the
treatment arms, should not be included in this study. Subjects who are included
in this study will receive an increased level of care from their physicians as
a result of participation, specifically additional follow-up visits and AE
assessments.
Given the available information above, the data support that for use in the
treatment of lower extremity symptomatic varicose veins, the probable benefits
of treatment with the VenaSeal* system, treatment with ETA, or treatment
through a surgical stripping procedure outweigh the probable risks.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
1. Patient is >=18 years of age
2. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV,
accessory saphenous veins) with CEAP category 2 (symptomatic) or CEAP category
3, 4a, 4b, 5, 6 based on the American Venous Forum CEAP classification (2004),
appropriate for treatment, as confirmed by DUS
3. Eligibility for treatment:
• VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal*
system and ETA
• VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with
the VenaSeal* system and surgical stripping
• VLU study: patients should be eligible for treatment with the VenaSeal*
system.
4. Treatable refluxing segment of target vein(s) 10 cm in length or longer
5. Patient has a target vein diameter of >=3 mm throughout the intended treated
segment of the target vein as measured by DUS while patient is standing
6. Patient is willing and capable of complying with specified follow-up
evaluations at the specified times
7. Patient has an ability to understand the requirements of the study and to
provide informed consent
Exclusion criteria
1. Patient has a known history of allergic sensitivities (including but not
limited to cyanoacrylate adhesives), or any other condition, which in the
opinion of the investigator may make the patient more susceptible to
cyanoacrylate adhesive hypersensitivity
2. Patient has known deep vein obstruction in the target limb, as identified by
the site*s standard of care
3. Patient has abnormal pulse exam or ABI <0.8
4. Patient has acute superficial thrombophlebitis
5. Patient requires any non-target vein treatments in the contralateral or
ipsilateral limb, or any other surgical procedure 30 days pre-procedure and
through 3 months post-procedure
6. Patient has any co-morbid conditions, which in the investigator*s opinion
may interfere with the patient*s compliance with study visits and procedures,
or may confound interpretation of study data (e.g., congestive heart failure
Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life
expectancy < 1 year)
7. IFU contraindications:
• VenaSeal vs. ETA Study: Patient has VenaSeal* system and ETA product*s IFU
contraindication(s)
• VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and
VenaSeal* system IFU contraindication(s)
• VLU study: Patient has VenaSeal* system IFU contraindication(s)
8. Patient is non-ambulatory
9. Patient is a female of childbearing potential who may be pregnant or
breastfeeding at the time of the index procedure
10. Patient belongs to a vulnerable population per investigator's judgment or
patient has any kind of disorder that compromises his/her ability to give
written informed consent and/or to comply with study procedures
11. Patient is currently participating in an investigational drug or device
study when the data collected could be conflicting or biased due to
participation in another study
12.Patient has documented COVID-19 infection currently or within the past 3
months . Patient is not completely recovered from past COVID-19 infection, per
physician's discretion.
13. VLU Study: Patient has target ulceration identified to be of non-venous
etiology, as confirmed by the independent core laboratory
14. VLU Study: Patient has target circumferential ulceration that cannot be
captured in a single photograph (any ulcer curvature around the leg that goes
out of sight)
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 |
|---|---|
| ClinicalTrials.gov | NCT03820947 |
| CCMO | NL73627.091.20 |