Actively Recruiting
Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation
Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2025-12-03
400
Participants Needed
2
Research Sites
136 weeks
Total Duration
On this page
Sponsors
G
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead Sponsor
V
Vivactis M2Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 or over who has read and signed the consent form after a reflection period
- Outpatients diagnosed with superficial venous insufficiency with a surgical indication
- Patients requiring sedation along with local anesthesia
You will not qualify if you...
- Contraindication to local anesthesia or any sedatives used in the study
- Hearing or visual impairment that prevents use of the virtual reality headset
- Pregnant or breastfeeding patients
- Uncontrolled epilepsy
- Patients under legal protection such as guardianship or curatorship
- Patients not affiliated with the French social security system
- Patients unable to understand or give written informed consent due to dementia, psychosis, altered consciousness, or language barriers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Clinique de l'Union
Saint-Jean, France, 31240
Actively Recruiting
2
Hôpital Privé de Villeneuve d'Ascq - Ramsay Santé 20 Av. de la Reconnaissance, 59650 Villeneuve-d'Ascq
Villeneuve-d'Ascq, France, 59650
Actively Recruiting
Research Team
L
Lauranne MATRAY, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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