Skip to content

Tomy; Lasercrossectomy versus EVLA

Tomy; Lasercrossectomy versus EVLA - Tomy; Lasercrossectomy versus EVLA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47125
Enrollment
100
Registered
2018-03-27
Start date
2016-04-11
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

recurrent veins Varicosis

Interventions

Lasercrossectomy After the patient is positioned on the operating table. DUS-guided percutaneous access to the GSV at the most distal insufficient part is obtained with 18 G needle. A 5 F 11 cm she
cold saline (5-10 °C) is administered under DUS guidance with a roller pump (Nouvag Dispenser DP20). After complete installment of the tumescent fluid the location of the tip of the fiber is contro
Lasercrossectomy

Sponsors

Biolitec Pharma
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Patients age > 18 3 mm. 5. DUS visible AASV joining the GSV 6. Incompetent SFJ after provocation manoeuvres 7. CEAP C2-C6

Exclusion criteria

Exclusion criteria: 1. Patients age 80 years. 2. Mean diameter of GSV

Design outcomes

Primary

MeasureTime frame
Primary endpoints 1. DUS reflux status of AASV 2. Visible recurrent varicose veins connected to AASV. 3. DUS detected neovascularisation

Secondary

MeasureTime frame
Secondary endpoints 4. DUS detected SFJ reflux and proof of GSV ablation 5. Residual GSV stump length 6. Diameter intrafascial AASV before and after GSV ablation 7. Patency of the Superior Epigastric Vein 8. Thrombotic and other complications 9. Venous severity ( VCSS) and quality of life (QoL)

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)