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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03820947




Registration number
NCT03820947
Ethics application status
Date submitted
8/01/2019
Date registered
29/01/2019

Titles & IDs
Public title
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Scientific title
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early & Advanced Stage Superficial Venous Disease
Secondary ID [1] 0 0
MDT18034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Reflux 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - VenaSeal™ Closure System
Treatment: Devices - Endothermal Ablation (ETA)
Treatment: Surgery - Surgical Stripping

Experimental: VenaSeal™ Closure System - CEAP 2-5 subjects will be randomized to VenaSeal™ Closure System vs. ETA or Surgical Stripping

Active comparator: Endothermal Ablation (ETA) - CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or ETA

Active comparator: Surgical Stripping - CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or surgical stripping (outside of the United States only)

Other: VenaSeal™ Closure System VLU Study - CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ Closure System


Treatment: Devices: VenaSeal™ Closure System
The VenaSeal™ closure system is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Treatment: Devices: Endothermal Ablation (ETA)
ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein.

Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Treatment: Surgery: Surgical Stripping
Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Venous treatment satisfaction questionnaire-early (VenousTSQe)(For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
Timepoint [3] 0 0
Index procedure
Primary outcome [4] 0 0
Time to ulcer healing (For VLU study)
Timepoint [4] 0 0
Index procedure through 12 months
Secondary outcome [1] 0 0
Anatomic closure of the primary target superficial truncal vein
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Time to return to work
Timepoint [2] 0 0
Through study completion, an average of 30 days
Secondary outcome [3] 0 0
Anatomic closure of primary target vein
Timepoint [3] 0 0
30 days, and 12, 24, 36, 48 and 60 months (30 days and 12 months only for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [4] 0 0
Anatomic closure of target vein
Timepoint [4] 0 0
30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [5] 0 0
Technical success of each target vein
Timepoint [5] 0 0
Index procedure
Secondary outcome [6] 0 0
Reintervention of any target vein
Timepoint [6] 0 0
Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [7] 0 0
Time to reintervention of any target vein
Timepoint [7] 0 0
Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [8] 0 0
Adverse events (AEs) occurring in the target limb
Timepoint [8] 0 0
Index procedure through 12 months
Secondary outcome [9] 0 0
Additional adverse events
Timepoint [9] 0 0
Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [10] 0 0
Healthcare utilization measured by the number of each type of adjunctive treatment.
Timepoint [10] 0 0
Index procedure through 12 months
Secondary outcome [11] 0 0
Healthcare utilization measured by number of healthcare resources and other health related resources utilized for target limb venous reflux disease
Timepoint [11] 0 0
Index procedure through 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [12] 0 0
Healthcare utilization measured by number of healthcare resources utilized for adverse events
Timepoint [12] 0 0
Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [13] 0 0
For VLU study only: Healthcare utilization measured by number of ulcer related healthcare resources utilized
Timepoint [13] 0 0
Index procedure through 60 months
Secondary outcome [14] 0 0
Time to return to normal activities
Timepoint [14] 0 0
Through study completion, an average of 30 days
Secondary outcome [15] 0 0
Intra-procedural and post-procedural pain
Timepoint [15] 0 0
Index procedure, and 7 days and 30 days
Secondary outcome [16] 0 0
Change in venous disease symptoms compared to baseline measured by the revised Venous Clinical Severity Score (rVCSS)
Timepoint [16] 0 0
7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [17] 0 0
Change in venous disease symptoms compared to baseline as measured by subject self-reporting symptoms
Timepoint [17] 0 0
7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [18] 0 0
Change in Aberdeen Varicose Vein Questionnaire (AVVQ) score compared to baseline
Timepoint [18] 0 0
30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [19] 0 0
Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) compared to baseline
Timepoint [19] 0 0
30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [20] 0 0
Change in the 36-Item Short Form Health Survey (SF-36) compared to baseline
Timepoint [20] 0 0
30 days, and 6 and 12 months
Secondary outcome [21] 0 0
Change in the Venous Dependent Quality of Life (VenousDQoL) compared to baseline
Timepoint [21] 0 0
30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
Secondary outcome [22] 0 0
Provider experience evaluating overall satisfaction with the procedure
Timepoint [22] 0 0
Index procedure
Secondary outcome [23] 0 0
For VLU Study: Ulcer recurrence on the target limb
Timepoint [23] 0 0
Following ulcer healing through 60 months
Secondary outcome [24] 0 0
For VLU study: Ulcer healing rate
Timepoint [24] 0 0
Index procedure through 24 months or until ulcer healing has been confirmed
Secondary outcome [25] 0 0
For VLU Study: Ulcer-free time
Timepoint [25] 0 0
Through 60 months
Secondary outcome [26] 0 0
For VLU Study: Venous treatment satisfaction questionnaire-early (VenousTSQe)
Timepoint [26] 0 0
30 days
Secondary outcome [27] 0 0
For VLU Study: Venous treatment satisfaction questionnaire- status (VenousTSQs)
Timepoint [27] 0 0
30 days
Secondary outcome [28] 0 0
For VLU Study: Percentage of target vein treated
Timepoint [28] 0 0
Index procedure

Eligibility
Key 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 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 up tp 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/or ETA product's IFU contraindication(s)
* VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2028
Actual
Sample size
Target
Accrual to date
Final
506
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
France
State/province [11] 0 0
DIjon Cedex
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
France
State/province [13] 0 0
Toulouse
Country [14] 0 0
Germany
State/province [14] 0 0
Halle
Country [15] 0 0
Italy
State/province [15] 0 0
Milano
Country [16] 0 0
Italy
State/province [16] 0 0
Padova
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
Netherlands
State/province [18] 0 0
Arnhem
Country [19] 0 0
Spain
State/province [19] 0 0
Granada
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Bedford
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Cambridge
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Harrow
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Endovascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kathleen Gibson, MD
Address 0 0
Lake Washington Vascular, US
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03820947