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临床试验/NCT07678697
NCT07678697招募中不适用

Comparative Study Between Nd:YAG Laser Combined With Injection Sclerotherapy Versus Diode Laser in the Treatment of Reticular Veins and Telangiectasias Using CLaCS Technique

Ain Shams University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年6月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Degree of vein clearance

研究概览

简要总结

This study aims to compare the efficacy (in terms of vein clearance) and safety of Nd:YAG laser combined with injection sclerotherapy versus diode laser combined with injection sclerotherapy in the treatment of reticular veins and telangiectasias using the Cryo-Laser and Cryo-Sclerotherapy (CLaCS) technique.

详细描述

Reticular veins and telangiectasias (spider veins) represent common chronic venous disorders affecting a large proportion of the adult population, particularly women.

The Cryo-Laser and Cryo-Sclerotherapy (CLaCS) technique has emerged as an innovative method combining transdermal laser therapy, injection sclerotherapy, and skin cooling. This multimodal approach enhances visualization of feeder veins using augmented reality or vein illumination systems, allowing precise targeting and improved clearance rates. Cooling reduces pain and protects the epidermis, making the procedure more tolerable and safer.

Nd:YAG laser (1064 nm) is considered the cornerstone of the CLaCS technique due to its deeper penetration and selective photothermolysis of hemoglobin. It effectively targets deeper reticular veins (up to 3-4 mm depth), induces vessel wall contraction, and facilitates subsequent sclerotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-60 years.
  • Both sexes.
  • Presence of reticular veins and/or telangiectasias (CEAP classification C1).
  • Fitzpatrick skin types II-V.
  • Patients seeking cosmetic treatment.

排除标准

  • Pregnancy or lactation.
  • History of deep vein thrombosis.
  • Coagulation disorders.
  • Allergy to sclerosant agents.
  • Active skin infection at treatment site.
  • Previous treatment of target veins within 6 months.
  • Great saphenous vein or short saphenous vein incompetence.
  • Deep venous insufficiency or thrombosis.
  • Abnormal venous duplex findings.

结局指标

主要结局

Degree of vein clearance

时间窗: 6 months postoperatively

Degree of vein clearance will be assessed by immediate endpoint response during laser application, defined as either instantaneous disappearance of the vein or an immediate change in vein color.

次要结局

  • Degree of pain(6 months postoperatively)
  • Degree of patient satisfaction(6 months postoperatively)
  • Incidence of complications(6 months postoperatively)
  • Number of treatment sessions required(6 months postoperatively)
  • Recurrence rate(6 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MohamedAhmed

Lecturer of Vascular Surgery, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Ain Shams University

研究点 (1)

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