[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656120":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":31,"interventions":38,"overallOfficials":44,"centralContacts":48,"locations":58,"responsibleParty":89,"collaborators":23,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":23,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":23,"enrollmentInfo":100,"targetDuration":23,"studyType":103,"phases":104,"briefSummary":105,"conditions":106,"keywords":23,"overallStatus":108,"whyStopped":23,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"MedVasc AB","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Safety related to the procedure using the Solutio™ catheter.","Safety evaluated by recording the number and type of adverse device effects (ADEs) and serious adverse device effects (SADEs) related to the procedure using the Solutio™ catheter.","28 days",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Patient experience of pain","The patient will rate their experience of pain at follow up visits at the clinic and via phone contacts. A Visual Analogue Scale (VAS) measures pain intensity. The scale consists of a 100 mm line, with two end points representing 0 = \"no pain\" and 100 = \"worst pain imaginable\". The patient will be asked to make a mark across the line according to the maximum experienced pain to indicate their pain at given timepoints. At phone contacts the patient is asked a standard question to rate their pain with a number from 0 to 10, a Numeric Rating Scale (NRS), where 0 = \"no pain\" and 10 = \"worst pain imaginable\"",{"measure":18,"description":19,"timeFrame":20},"Physician feedback","After the end of the procedure, the physician is asked to provide their feedback, assessment about 10 different aspects during the procedure. They will answer with a 4-grade scale (1 is excellent, 2 is good, 3 is fair, 4 is impossible \u002Finadequate). Acceptable score is ≤3 for each question.","1 day",{"measure":15,"description":22,"timeFrame":12},"At phone contacts the patient is asked a standardized question to rate their pain with a number from 0 to 10, a Numeric Rating Scale (NRS), where 0 = \"no pain\" and 10 = \"worst pain imaginable\".",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"NA","SINGLE_GROUP","Safety study","OTHER",{"masking":30,"maskingDescription":23,"whoMasked":23},"NONE",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"Solutio™ catheter used to administrate tumescence during endothermal ablation of varicose veins","EXPERIMENTAL","Administration of tumescence from inside the vein to the surrounding tissue, via Solutio™ catheter during endothermal ablation of varicose veins.",[37],"Device: Administration of local anesthesia",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":23},"DEVICE","Administration of local anesthesia","The Solutio™ catheter presents a technique that allows for tumescent anesthesia injections to be administered at selected sites along the vein, from inside the vein to the surrounding tissue.\n\nThe purpose of the Solutio™ catheter is to prevent the pain associated with multiple injections, through sensitive skin layers along the inner side of the leg, administered prior to ablation.",[33],[45],{"name":46,"affiliation":5,"role":47},"Michael Akesson, MD","STUDY_DIRECTOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":23,"email":53},"Ingegerd W Dalfelt, SRN, BSc.","CONTACT","+46708433348","ingegerd.dalfelt@gmail.com",{"name":55,"role":51,"phone":56,"phoneExt":23,"email":57},"Cathrin Johansson, BSc","+46708548834","cathrin.johansson@medvasc.se",[59,76],{"facility":60,"status":23,"city":61,"state":23,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Hallands sjukhus","Halmstad","301 85","Sweden","SE",{"type":66,"coordinates":67},"Point",[68,69],12.85676,56.67446,{"lat":69,"lon":68},[72],{"name":73,"role":51,"phone":74,"phoneExt":23,"email":75},"Karin Ludwigs, MD","+46 (0)35 14 77 53","Karin.Ludwigs@regionhalland.se",{"facility":77,"status":23,"city":78,"state":23,"zip":79,"country":63,"countryCode":64,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Scandinavian Venous Centre","Malmö","21135",{"type":66,"coordinates":81},[82,83],13.00073,55.60587,{"lat":83,"lon":82},[86],{"name":73,"role":51,"phone":87,"phoneExt":23,"email":88},"+46707382447","karin.ludwigs@svcgoteborg.se",{"type":90,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100656120","open-label-safety-investigation-of-solutio-tumescent-catheter-100656120",false,"NCT07823088","Open Label Safety Investigation of Solutio™ Tumescent Catheter","A Prospective, Open Label Investigation of Safety of the Solutio™ Tumescent Catheter for Endothermal Ablation of Varicose Veins","Inclusion Criteria:\n\n1. Male or Female \\>18 years old.\n2. Subject diagnosed with venous insufficiency in the Great Saphenous Vein from the groin to the proximal 1\u002F3 of the lower leg and with a Clinical Etiological Anatomical Pathophysiological (CEAP) classification of 2 or higher.\n3. Subject is scheduled for an EVLA or RFA procedure for a unilateral insufficiency of the GSV.\n4. Subject accepts to be treated with endothermal ablation as a standalone method.\n5. Subject accepts to be treated without any sedation.\n6. Subject is willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Considered as being of high risk due to comorbidity in the opinion of the investigator.\n2. Subject with known and confirmed coagulation defects.\n3. Subject on anticoagulant treatment.\n4. Subject who simultaneously needs to be treated with other supplemental techniques such as e.g., foam sclerotherapy, ligation, and phlebectomy.\n5. Subject with GSV insufficiency in the distal 2\u002F3 of the lower leg.\n6. Subject, who demands full sedation, or general anesthesia.\n7. Subject with known allergy to any of the tumescent and\u002For anesthetizing agents that will be used (per local standard practice) during the endothermal ablation procedure.","ALL","18 Years",{"count":101,"type":102},30,"ESTIMATED","INTERVENTIONAL",[25],"The goal of this clinical investigation is to evaluate safety of the Solutio™ catheter when administering tumescent anesthesia before treatment with endothermal ablation in adults above the age of 18, who suffer from unilateral insufficiency of the great saphenous vein (GSV).\n\nMain question(s) to answer is:\n\nSafety evaluated through reported Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs).\n\nIncidence of Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE), and device deficiency (DD) throughout the investigation.\n\nAll investigation participants will:\n\n* Undergo screening, including medical history, physical examination, and vein mapping with Doppler ultrasound.\n* Have their Great Saphenous Vein (GSV) treated using Seldinger technique under ultrasound guidance.\n* Receive tumescent anesthesia injected from inside the vein into the perivascular tissue at selected sites along the vein, using the investigational Solutio™ catheter under ultrasound guidance.\n* Undergo endothermal ablation, Endovenous Laser Ablation (EVLA), or Radiofrequency Ablation (RFA).\n* Be followed up for 28 days through scheduled phone calls (Day 1, Day 14 ±2) and clinic visits (Day 7 ±1, Day 28 ±2) to assess adverse events, pain, patient comfort, and undergo physical\u002Fclinical examinations and ultrasound examinations of the treated area.",[107],"Venous Insufficiency","NOT_YET_RECRUITING","2026-09-10",{"date":111,"type":112},"2026-09-16","ACTUAL",{"date":114,"type":102},"2026-09-28",{"date":116,"type":102},"2027-02-28",{"name":5,"class":6},2]