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Sono-morphology after endovenous laser ablation (EVLA) with 1940 nm and radial abstracting fiber versus 1470 nm and radial emitting fiber, 1-year follow-up of a prospective, multicenter, randomized controlled trial (1470 vs. 1940 laser study)

Sono-morphology after endovenous laser ablation (EVLA) with 1940 nm and radial abstracting fiber versus 1470 nm and radial emitting fiber, 1-year follow-up of a prospective, multicenter, randomized controlled trial (1470 vs. 1940 laser study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028864
Enrollment
66
Registered
2023-05-12
Start date
2023-10-19
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I83.9

Interventions

Group 1: laser treatment with 1470 nm wavelength Number of visits: 6 Visit 1: time of recruitment Visit 2: day of laser ablation Visit 3: until 10 days after treatment Visit 4: 3 months after treatmen

Sponsors

Katholisches Klinikum gGmbHVenenzentrum der Dermatologischen und Gefäßchirurgischen Klinken, Standort St.-Maria Hilf-Krankenhaus
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with varicose veins and a classification CEAP ... - Patients scheduled for elective endovenous laser therapy with a refluxive VSM of at least stage II according to Hach - Patients = 18 years of age - Written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: - Tortuous VSM unsuitable for endovenous treatment - Patients with an incompetent anterior saphenous vein - Duplication of the saphenous trunk - Deep venous insufficiency - Patients who are unable to give informed consent (e.g., impaired mental status, inadequate knowledge of the German language) - Expected non-compliance

Design outcomes

Primary

MeasureTime frame
Closure rate, echogenicity, and diameter of the occluded vessel at the 6-month time point—

Secondary

MeasureTime frame
- Occlusion rate, echogenicity, and diameter of the occluded vessel at the other examination time points. - (postoperative) pain: VAS scale - Hyperpigmentation at the further examination time points: none, slight, moderate, strong - Paresthesias at the examination time points: Coagulation on fibers (no visual change - clean and clear fiber tip, visual change - remnants of tissue or blood can be wiped off, visual change - permanent traces of charred blood or tissue) - Patient satisfaction: Venous Clinical Serverity Score (VCSS). - Disease-specific quality of life: Aberdeen Varicose Vein Symptom Severity Score (AVVQ) - Duration of absence from work and normal activities - Applicability of the pull-back device - Bruising - Edema - Wound healing disorders - Deep thrombosis—

Countries

Germany

Contacts

Public ContactSonja Feldmann-Plum

Katholisches Klinikum gGmbHVenenzentrum der Dermatologischen und Gefäßchirurgischen Klinken, Standort St.-Maria Hilf-Krankenhaus

team-phlebo@klinikum-bochum.de0234 8792 274

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026