Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Surgery or Noninvasive Therapy for Varicose Veins

NCT00529672

Varicose Vein

UNKNOWN PHASE3

Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities

NCT01197833

Great Saphenous Vein Incompetence Visible Varicosities

COMPLETED PHASE3

Early Outcome of Mechanochemical Endovenous Ablation

NCT01459263

Varicosis

COMPLETED

Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein

NCT02236338

Chronic Venous Insufficiency

COMPLETED PHASE4

Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

NCT02454452

Varicose Veins

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The main objective of the study is to test the non-inferiority of the effect of sedation by the virtual reality device on the intensity of maximum intraoperative pain compared with the usual neuroleptanalgesic treatment, tolerating a margin of non-inferiority of 0.5 points.Pain will be assessed on an ENS immediately at the end of the surgical procedure.

Prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients.

Maximum duration of patient participation in the study = 2 days.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Superficial Venous Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients.

Maximum duration of patient participation in the study = 2 days.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

usual neuroleptanalgesic treatment

\- Group 1: local anaesthesia by tumescence + neuroleptanalgesia

Group Type ACTIVE_COMPARATOR

Neuroleptanalgesia

Intervention Type DRUG

Usual neuroleptanalgesic treatment

use of a device incorporating virtual reality software

\- Group 2: local anaesthesia by tumescence with virtual reality software

Group Type EXPERIMENTAL

use of a device incorporating virtual reality software

Intervention Type DEVICE

use of a device incorporating virtual reality software

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

use of a device incorporating virtual reality software

Intervention Type DEVICE

Neuroleptanalgesia

Usual neuroleptanalgesic treatment

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient aged 18 or over, who has read and signed the consent form for participation in the study after a reflection period (approximately 1 hour).
* Outpatients with superficial venous insufficiency for which a surgical indication has been given
* Patient requiring sedation associated with local anesthesia

Exclusion Criteria

* Contraindication to local anesthesia or any of the sedatives used in the protocol
* Hearing or visual impairment contraindicating use of the virtual reality headset
* Pregnant or breast-feeding patients
* Unbalanced epilepsy
* Patients under court protection, guardianship or curatorship
* Patients not affiliated to the French social security system
* Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patient

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No