Actively Recruiting

Age: 18Years - 90Years
All Genders
NCT06693245

Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation, and Analysis of Related Factors

Led by Chengdu University of Traditional Chinese Medicine · Updated on 2024-11-18

155

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Objective: This study is a single-center prospective observational research that recorded patients' pain scores at four time points during surgery (puncture and catheter insertion, swelling fluid injection, microwave generator operation, and end of surgery). It analyzed the correlation between pain during microwave ablation treatment for great saphenous vein varicosities and factors such as age, gender, body mass index, volume of swelling fluid used, and others, in order to summarize and improve surgical details to reduce patients' intraoperative pain.

CONDITIONS

Official Title

Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation, and Analysis of Related Factors

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 90 years old
  • Life expectancy greater than 12 months
  • Clinical diagnosis of primary varicose veins, CEAP classification C2-C6, with symptoms such as pain, burning, heaviness, fatigue, itching, or night cramps
  • Doppler ultrasound confirmation of great saphenous vein diameter between 3mm and 12mm when standing
  • Great saphenous vein located in the saphenofascia or more than 1 cm below the skin surface confirmed by Doppler ultrasound
  • Endovenous microwave ablation treatment planned only for unilateral great saphenous vein
  • Willingness to cooperate with required examinations per the study protocol
Not Eligible

You will not qualify if you...

  • Presence of great saphenous vein thrombosis or deep vein thrombosis, or history of deep vein thrombosis or pulmonary embolism
  • Recurrence after previous varicose veins surgery (C2r)
  • Severe distortion of the great saphenous vein trunk preventing catheter passage
  • Severe lower limb ischemia with ankle brachial pressure index less than 0.8
  • Known allergy to drugs or device materials used in the study
  • Implanted pacemaker or defibrillator and current regular anticoagulation therapy
  • Pregnant or breastfeeding females
  • Inability or unwillingness to participate in the study
  • Participation in other drug or device research
  • Presence of skin malignancies other than treated non-melanoma
  • Daily use of narcotic or non-steroidal anti-inflammatory drugs for venous disease pain
  • Investigator judgment that endovenous treatment is unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China, 610000

Actively Recruiting

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Research Team

C

Chunshui He, Doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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