Endovenous Laser Ablation With 1940 nm Versus 1470 nm

NCT07603570 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: KFSIRB200-730
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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. 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. 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. 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• Anatomical success

  complete occlusion of the treated vein segment, defined as absence of flow on duplex ultrasonography at 6 months.

  at 6 months.

Study Arms (2)

group 1 -1470

ACTIVE COMPARATOR

EVLA will be performed using a 1470 nm diode laser with radial fiber. Power and LEED will follow standard clinical practice guidelines for this wavelength.

Procedure: EVLA for SFJ with laser 1470

group 2-1940

EXPERIMENTAL

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.

Procedure: EVLA for SFJ with laser 1940

Interventions

EVLA for SFJ with laser 1470 PROCEDURE

EVLA for SFJ with laser 1470

group 1 -1470

EVLA for SFJ with laser 1940 PROCEDURE

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.

group 2-1940

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years) diagnosed with symptomatic varicose veins.
• Clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification C2-C6.
• Duplex ultrasound evidence of saphenous vein incompetence (reflux ≥0.5 seconds in standing position).
• Great saphenous vein (GSV), small saphenous vein (SSV), or accessory saphenous vein diameter suitable for endovenous treatment (\<12 mm).
• Patients able to provide informed consent.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

KSUH

Kafr ash Shaykh, 33516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: one year

Locations

EG (1)