- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03455699
VeClose Five Year Follow-Up Extension Study
10 april 2019 uppdaterad av: Medtronic Endovascular
Follow-up of Patients Treated in VeClose Study (Five Years)
The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data from the patients enrolled in the VeClose study (NCT01807585).
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
The VeClose Five Year Follow-up Extension Study will continue to assess the safety and efficacy of the VenaSeal Closure System for the long term effect on closure of the great saphenous vein by conducting a follow-up visit at five years post index procedure/enrollment in the VeClose study.
Studietyp
Observationell
Inskrivning (Faktisk)
114
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Arizona
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Scottsdale, Arizona, Förenta staterna, 85255
- Morrison Vein Institute
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California
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San Diego, California, Förenta staterna, 92121
- GBK Cosmetic Laser Dermatology
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Colorado
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Greenwood Village, Colorado, Förenta staterna, 80111
- Radiology Imaging Associates (RIA)
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Illinois
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Springfield, Illinois, Förenta staterna, 62701
- Prairie Education & Research Cooperative
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Maryland
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Hunt Valley, Maryland, Förenta staterna, 21030
- MD Laser Skin & Vein Institute
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New York
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North Tonawanda, New York, Förenta staterna, 14120
- Vein Institute of Buffalo
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Oregon
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Bend, Oregon, Förenta staterna, 97701
- Inovia Vein Speciality Center
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Virginia
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Virginia Beach, Virginia, Förenta staterna, 23452
- Sentara Vascular Specialists
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Washington
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Bellevue, Washington, Förenta staterna, 98004
- Lake Washington Vascular
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Subjects currently enrolled in both arms of the VeClose Study (NCT01807585) will be assessed for eligibility to enroll in the VeClose Five Year Follow-up Extension Study.
All subjects must meet the inclusion criteria and must not meet the exclusion criteria.
Assessment of eligibility is based on data available to the investigator at the time of subject enrollment.
The subject will be considered to be enrolled in the VeClose Five Year Follow-up Extension Study after the informed consent is signed/dated and all of the study eligibility criteria have been met.
Beskrivning
Inclusion Criteria:
- Enrolled in the VeClose study.
- Able and willing to complete the required 5 year study visit including Duplex ultrasound exam.
- Able and willing to provide written informed consent prior to study specific data collection.
Exclusion Criteria:
1. Withdrew consent from the VeClose study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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Experimental: VenaSeal SCS
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV).
The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc.
Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or to RFA at the time of enrollment into the VeClose study (NCT01807585).
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Icke-tumescent, icke-termisk, icke-skleroserande procedur som använder ett patentskyddat medicinskt lim som levereras endovenöst för att stänga venen.
Andra namn:
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Active Comparator: RFA
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV).
Heat is applied to the target vein using radiofrequency energy to ablate the target vein.
Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or to RFA at the time of enrollment into the VeClose study (NCT01807585).
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Radiofrekvens termisk ablation av GSV med hjälp av Covidien ClosureFast-systemet.
Andra namn:
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Experimental: Roll-in (VenaSeal SCS)
Prior to initiation of the randomized cohort at each site for the VeClose study (NCT01807585), a non-randomized cohort of 2 subjects per site (roll-in phase) were enrolled and treated with VenaSeal SCS with endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV).
The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc.
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Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585).
Tidsram: 5 years
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Complete closure is defined as Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5cm.
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5 years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Venous Clinical Severity Score (VCSS)
Tidsram: 5 years
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Change in Venous Clinical Severity Score (VCSS) at 5 years as compared to baseline data from the VeClose study (NCT01807585).
The VCSS is an Investigator assessment of the severity of venous reflux disease, assessing signs and symptoms such as pain, varicose veins, venous edema, skin pigmentation, induration and inflammation.
The VCSS score is the sum of responses to 10 questions.
Each question has a total possible of 3 points, which are then added for each question.
The overall VCSS scores can therefore range from 0 (no venous disease) to 30 (severe venous disease).
High scores indicate worse outcomes and "0" is the best possible outcome.
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5 years
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Aberdeen Varicose Vein Questionnaire (AVVQ)
Tidsram: 5 years
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Change in Aberdeen Varicose Vein Questionnaire (AVVQ) at 5 years as compared to baseline data from the VeClose study (NCT01807585).
AVVQ is a disease-specific 13-item questionnaire used to assess the impact of varicose veins on the quality of life, such as pain caused by varicose veins, and need to take painkilling tablets for varicose veins as well as assessing the presence of signs/symptoms such as ankle swelling, purple discoloration and rash/eczema.
The total score of AVVQ is the sum of all questions for each leg.
Scores range from 0 (no disease) to 100 (maximal disease).
High scores indicate worse outcomes and "0" is the best possible outcome.
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5 years
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Quality of Life survey (EQ-5D)
Tidsram: 5 years
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Change in Quality of Life survey (EQ-5D) at 5 years as compared to baseline data from the VeClose study (NCT01807585).
EQ-5D is a short generic quality of life survey that is commonly used outside of the United States for health technology assessments.
The "health state today" question provides an overall assessment along a 20-cm visual analog scale (VAS) with a range from 0 ("worst imaginable health state") to 100 ("best imaginable health state").
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5 years
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CEAP classification ("clinical, etiology, assessment and pathophysiology")
Tidsram: 5 years
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Standardized measure of the degree of venous insufficiency and secondary manifestations of venous disease as measured by the treating physician.
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5 years
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Satisfaction with Treatment
Tidsram: 5 years
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Satisfaction with Treatment assessment consists of a brief 2-question patient survey rating satisfaction with treatment provided and whether the subject would undergo the assigned treatment again.
The number (percent) of subjects on each level of satisfaction are summarized (Very satisfied, Somewhat satisfied, Somewhat dissatisfied, Very dissatisfied).
The number (percent) of subjects for the second satisfaction question, "would undergo treatment again" were also summarized by response (Definitely have again, Might have again, Not have again).
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5 years
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Adverse events (AE) related to the target GSV
Tidsram: 5 years
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AEs related to the GSV will be tabulated and reporting using the MedDRA dictionary, version 16.1.
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5 years
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Adjunctive procedures performed on the study limb
Tidsram: 5 years
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Details of adjunctive procedures performed on the study limb will be captured on Case Report Forms (CRFs)
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5 years
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Nick Morrison, MD, Morrison Vein Institute
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Morrison N, Gibson K, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):321-330. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6.
- Kolluri R, Gibson K, Cher D, Madsen M, Weiss R, Morrison N. Roll-in phase analysis of clinical study of cyanoacrylate closure for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):407-15. doi: 10.1016/j.jvsv.2016.06.017. Epub 2016 Aug 8.
- Morrison N, Gibson K, Vasquez M, Weiss R, Jones A. Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):978-989. doi: 10.1016/j.jvsv.2019.12.080. Epub 2020 Mar 20.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2016
Primärt slutförande (Faktisk)
1 januari 2019
Avslutad studie (Faktisk)
1 januari 2019
Studieregistreringsdatum
Först inskickad
28 februari 2018
Först inskickad som uppfyllde QC-kriterierna
28 februari 2018
Första postat (Faktisk)
6 mars 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 april 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 april 2019
Senast verifierad
1 april 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CP-1011
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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Medtronic EndovascularSapheon, Inc.AvslutadGreat Saphenous Ven (GSV) med venös refluxsjukdomFörenta staterna
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