MedTrace Logo

Endovenous Laser Ablation With 1940 nm Versus 1470 nm

NCT07603570 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-05-22

No results posted yet for this study

Summary

1. Study Design: A single-blind, prospective, randomized controlled trial (RCT) conducted at Kafrelsheikh University Hospital to compare the efficacy and safety of 1940 nm vs. 1470 nm diode lasers for EVLA.
2. Participants: The trial will enroll 220 adult patients (110 per group) presenting with symptomatic varicose veins (CEAP C2-C6) and duplex-proven saphenous reflux with a vein diameter \\bm{\< 12\\text{ mm}}.
3. Randomization \& Blinding: Patients are randomized in a 1:1 ratio via computer-generated sequences in sealed envelopes; patients and outcome assessors are strictly blinded, while the operating surgeon is unblinded.
4. Anesthesia: Procedures are performed under ultrasound-guided Local Tumescent Anesthesia (0.1% lidocaine with sodium bicarbonate in saline) to provide analgesia, a thermal sink, and venous compression.
5. Surgical Technique: A 600-µm radial fiber is introduced through a 6F sheath and positioned 2 cm distal to the SFJ/SPJ, followed by ablation in the Trendelenburg position at a pullback speed of 1 mm/s.
6. Laser Metrics: Group I (1940 nm) will utilize lower power settings (4-6 W; target LEED 30-50 J/cm), while Group II (1470 nm) will follow standard practice guidelines (10-12 W; target LEED 60-80 J/cm).
7. Follow-up \& Outcomes: Longitudinal surveillance will occur at Day 1, Day 7, 1 month, and 6 months, with the primary outcome defined as anatomical success (complete vein occlusion via duplex ultrasound at 6 months).
8. Statistical Analysis: Secondary metrics-including pain (VAS), clinical improvement (VCSS), and complications (EHIT, paresthesia)-will be analyzed via IBM SPSS, establishing a significance threshold of \\bm{p \< 0.05}.

Conditions

  • Varicose Veins of Lower Limb
  • Great Saphenous Vein (GSV) With Venous Reflux Disease

Interventions

PROCEDURE

EVLA for SFJ with laser 1470

EVLA for SFJ with laser 1470

PROCEDURE

EVLA for SFJ with laser 1940

EVLA will be performed using a 1940 nm diode laser with radial fiber. Power and LEED will be adjusted according to vein diameter, with anticipated lower power and energy requirements compared with 1470 nm.

Sponsors & Collaborators

  • Kafrelsheikh University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-01
Completion
2026-09-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07603570 on ClinicalTrials.gov