Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
Study NCT ID:
NCT04146168
Status:
UNKNOWN
Last Update Posted:
2019-10-31
First Post:
2019-10-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lake Washington Vascular VenaSeal™ Post-Market Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Closure of Target Vein(s) at 3 years after index treatment', 'timeFrame': '3 years post treatment', 'description': 'Complete closure is defined as Doppler Ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5 cm.'}], 'secondaryOutcomes': [{'measure': 'Venous disease severity assessed via Venous Clinical Severity Score', 'timeFrame': '3 years post treatment', 'description': 'Assessed via the revised Venous Clinical Severity Score (rVCSS). The rVCSS 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.'}, {'measure': 'Clinical Severity via Varicose Vein Questionnaire (AVVQ)', 'timeFrame': '3 years post treatment', 'description': 'Assessed via Aberdeen Varicose Vein Questionnaire (AVVQ) is a disease specific 13 item questionnaire is used to assess the impact of varicose veins on the quality of life, such as pain caused by varicose veins, and the need to take pain medication.'}, {'measure': 'Quality of Life and Patient Satisfaction of Treatment: EQ-5D Questionnaire', 'timeFrame': '3 years post treatment', 'description': 'Assessed via EQ-5D Questionnaire. The 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").'}, {'measure': 'Need for adjunctive treatments', 'timeFrame': '3 years post treatment', 'description': 'Either at the index procedure or at any point following the index procedure'}, {'measure': 'Health care utilization', 'timeFrame': '3 years post treatment', 'description': 'Via chart review and patient questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Venaseal', 'cyanoacrylate closure'], 'conditions': ['Varicose Veins', 'Venous Reflux']}, 'descriptionModule': {'briefSummary': 'New-WAVES Study seeks to expand understanding/results from prior study (NCT02585726). Assessing both clinical outcomes and patient satisfaction after treatment with Venaseal/Cyanoacrylate Adhesive Closure System', 'detailedDescription': 'New WAVES is an investigator initiated protocol that will assess clinical outcomes and patient satisfaction after treatment with VenaSeal(TM)/ Cyanoacrylate Adhesive Closure System 3 years post-treatment. All patients treated from a multi-provider practice, whom meet protocol inclusion criteria, will be invited to consider participation in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited from the practice by identification of all patients treated with the Venaseal Closure System from October 2015 to December 31, 2016. This will include 50 prior subjects whom participated in the WAVES trial (ClinicalTrials.gov Identifier: NCT02585726), and up to 75 additional subjects whom also received the treatment with Venaseal but were not enrolled in the WAVES trial. All potential subjects for this study will have received treatment at Lake Washington Vascular, PLLC. Prior WAVES trial subjects initially enrolled will be approached with an introductory letter to be sent via e-mail or physical address. The correspondence will be sent to all potential study subjects explaining the purpose of the study and inviting them to participate. This correspondence will be followed up with a phone contact from study personnel.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Age ≥18 years; 2. Treatment of the great, small or accessory saphenous vein or any combination of saphenous veins with the Venaseal Closure System; 3. Treatment occurred at least 30 months prior to study; 4. Ability to understand the requirements of the study and to provide informed consent.\n\n\\-\n\nExclusion Criteria:\n\n1\\. Subsequent treatment (such as laser or radiofrequency ablation) of venous disease in targeted vein segment after Venaseal closure; 2. Patients in whom index procedure information is unavailable; 3. Patients unwilling to undergo ultrasound evaluation and clinical examination of the previously treated limb; 4. Limbs that were treated in the VeClose trial (patients who participated in VeClose and later had contralateral limb treatment will be included).\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04146168', 'acronym': 'New-WAVES', 'briefTitle': 'Lake Washington Vascular VenaSeal™ Post-Market Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Lake Washington Vascular'}, 'officialTitle': 'Clinical and Patient-Centered Outcomes Three Years After Venaseal Treatment: Lake Washington Vascular VenaSeal Post Market Evaluation', 'orgStudyIdInfo': {'id': '2019-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VenaSeal', 'description': 'Complete closure of previously treated veins will be assessed via ultrasound', 'interventionNames': ['Diagnostic Test: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Unilateral ultrasound of Limb'], 'description': 'Closure of previously treated veins (with Venaseal) will be assessed via ultrasound.', 'armGroupLabels': ['VenaSeal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Glorieux, BS, BS, CCRC', 'role': 'CONTACT', 'email': 'kimg@lkwv.com', 'phone': '425-453-1772'}, {'name': 'Kathleen Gibson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Brian Ferris, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Renee Minjarez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elena Rinehardt, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Lake Washington Vascular', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98027', 'city': 'Issaquah', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Glorieux, BS, BS, CCRC', 'role': 'CONTACT', 'email': 'kimg@lkwv.com', 'phone': '425-453-1772'}, {'name': 'Kathleen Gibson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Brian Ferris, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Renee Minjarez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elena Rinehardt, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Lake Washington Vascular', 'geoPoint': {'lat': 47.5301, 'lon': -122.03262}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Glorieux, BS, BS, CCRC', 'role': 'CONTACT', 'email': 'kimg@lkwv.com', 'phone': '425-453-1772'}, {'name': 'Kathleen Gibson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Brian Ferris, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Renee Minjarez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elena Rinehardt, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Lake Washington Vascular', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}], 'centralContacts': [{'name': 'Kim D Glorieux, BS, BS, CCRC', 'role': 'CONTACT', 'email': 'kimg@lkwv.com', 'phone': '425-453-1772'}], 'overallOfficials': [{'name': 'Kathleen Gibson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lake Washington Vascular, PLLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lake Washington Vascular', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic Vascular', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}