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Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

NCT06228365 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-03

No results posted yet for this study

Summary

Virtual reality has been shown to reduce the pain experienced during medical procedures.

The aim of this study is to determine to what extent the use of this technique could make it possible to defer the administration of neuroleptanalgesia during the endovenous thermal treatment of superficial varicose veins in addition to local anaesthesia by tumescence.

Conditions

  • Superficial Venous Insufficiency

Interventions

DEVICE

use of a device incorporating virtual reality software

use of a device incorporating virtual reality software

DRUG

Neuroleptanalgesia

Usual neuroleptanalgesic treatment

Sponsors & Collaborators

  • Vivactis M2Research

    collaborator INDUSTRY

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

    lead OTHER

Principal Investigators

  • Lauranne MATRAY, MD · Clinique de l'Union

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • France

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 NCT06228365 on ClinicalTrials.gov