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Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins

NCT03835559 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2019-04-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.

Conditions

  • Occlusions Vein
  • Chronic Venous Insufficiency

Interventions

PROCEDURE

Cyanoacrylate closure

After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.

PROCEDURE

Surgical stripping

All types of anesthesia (general, spinal, regional block, or local anesthesia) can be used. The surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries. The saphenous vein is then removed using a stripper.

Sponsors & Collaborators

  • Kyung Hee University Hospital at Gangdong

    lead OTHER

Principal Investigators

  • Jin Hyun Joh, MD, PhD · Kyung Hee University Hospital at Gangdong, Seoul, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2020-08-01
Completion
2021-02-01

Countries

  • South Korea

Study Locations

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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 NCT03835559 on ClinicalTrials.gov