Endovenous laser ablation versus mechano-chemical endovenous ablation in the treatment of great saphenous incompetence: a multicentric, randomized controlled trial

Endovenous laser ablation versus mechano-chemical endovenous ablation in the treatment of great saphenous incompetence: a multicentric, randomized controlled trial - Clari-Laser study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36499

Enrollment

814

Registered

2011-08-16

Start date

2012-06-21

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

varicose veins

Interventions

Endovenous laser ablation Endovenous laser therapy or ablation is a minimally invasive treatment for varicose vein incompetence. This technique uses laser light to heat the greater saphenous vein.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Primary great saphenous incompetence 2. C2-C4 varicose veins 3. Ultrasound criteria have to be sufficient for endovenous therapy: diameter of the great saphenous vein > 3mm and 18 years and

Exclusion criteria

Exclusion criteria: 1. Patient not capable for informed consent 2. Pregnancy and lactation 3. Surgical or endovenous therapy for ipsilateral varicose vein incompetence in history 4. Deep venous trombosis in treated leg 5. Use of oral anticoagulantia 6. Contraindications or allergy for sclerosant 7. Immobilisation 8. Coagulation disorders or increased risk of tromboembolic complications 9. Peripheral arterial disease, Fontaine 3-4 10. Severe renal failure 11. Liver insufficiency 12. Other treatment modality is more appropriate for varicose vein treatment

Design outcomes

Primary

Measure	Time frame
Primary study parameters: - Technical success (occlussion percentage, demonstrated by duplex) - Clinical success (CEAP, VCSS) - Peroperative pain (VAS score) - Postoperative pain for 2 weeks (VAS score, amount of analgesia used)	—

Secondary

Measure	Time frame
Secondary study parameters: - Postoperative complications - Disease specific quality of life (AVVQ, SF-36) - Time from treatment to resumption of normal activities - Procedural lenght - Costs	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)