Superficial Venous InsufficiencyCIMESNCT06228365
Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation
A study testing use of a device incorporating virtual reality software and Neuroleptanalgesia in people with Superficial Venous Insufficiency, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Venous Insufficiency
- What is being tested?
- use of a device incorporating virtual reality software and Neuroleptanalgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Nov 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Clinique de l'Union
Saint-Jean, 31240
Lauranne MATRAY, MD, 05 61 37 81 81 ext. 33, dr.lmatray.union@gmail.com
- Recruiting
Hôpital Privé de Villeneuve d'Ascq - Ramsay Santé 20 Av. de la Reconnaissance, 59650 Villeneuve-d'Ascq
Villeneuve-d'Ascq, 59650
ADRIEN HERTAULT, Dr, +33(0)3 20 72 00 03, adhertault@hotmail.com
About this study
Official title: Efficacy of Digital Sedation Compared With Neuroleptanalgesia in Percutaneous Outpatient Surgery for Superficial Venous Insufficiency
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.
Read the detailed description
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
- Superficial Venous Insufficiency
- Being tested
- use of a device incorporating virtual reality software, Neuroleptanalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of a device incorporating virtual reality softwareDevice
use of a device incorporating virtual reality software
NeuroleptanalgesiaDrug
Usual neuroleptanalgesic treatment
| Study group | Role | What they receive |
|---|---|---|
| usual neuroleptanalgesic treatment | Active comparator | - Group 1: local anaesthesia by tumescence + neuroleptanalgesia Receives: Drug: Neuroleptanalgesia |
| use of a device incorporating virtual reality software | Experimental | - Group 2: local anaesthesia by tumescence with virtual reality software Receives: Device: use of a device incorporating virtual reality software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessed by NRS (numerical rating scale)
The intensity of maximum pain during the surgery will be assessed by numerical rating scale (NRS) graduated from 0 (no pain) to 10 (worst pain imaginable).
Measured: Day 1
Secondary outcomes (10)
Level of pre-operative anxiety assessed by the patient using the STAI-Y
The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory).
Measured: Day 0
Level of post-operative anxiety assessed by the patient using the STAI-Y
The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory).
Measured: Day 1
treatment administered during the procedure
Nature and quantities of additional sedative treatment administered during the procedure
Measured: Day 1
Pain intensity assessed by NRS (numerical rating scale)
Pain intensity assessed by NRS (numerical rating scale)
Measured: Day 1
Overall patient satisfaction post-opérative assessed by NRS (numerical rating scale)
Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied).
Measured: Day 0
Overall patient satisfaction day 1 assessed by NRS (numerical rating scale)
Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied).
Measured: Day 1
Surgery duration
Assessment of the surgery duration
Measured: Day 0
Length of stay in the ICU
Length of stay in the ICU
Measured: Day 1
Length of stay in the hospital
Length of stay in the hospital
Measured: Day 1
Resumption of current activities
Resumption of current activities measured by: YES or NO
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start20 Nov 2023
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients. Maximum duration of patient participation in the study = 2 days.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Vivactis M2Research
- Responsible party
- Sponsor
- Investigators
- Lauranne MATRAY, MD, Principal investigator, Clinique de l'Union
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228365
- Sponsor's protocol ID
- 2023-A01948-37
- Acronym
- CIMES
- Status last verified
- Nov 2025
- First submitted
- 14 Dec 2023
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Digital Sedation Compared With Neuroleptanalgesia in Percutaneous Outpatient Surgery for Superficial Venous Insufficiency
- ClinicalTrials.gov ID
- NCT06228365
- Acronym / sponsor ID
- CIMES / 2023-A01948-37
- Conditions
- Superficial Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Vivactis M2Research
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients. Maximum duration of patient participation in the study = 2 days.
| Arm | Type | Receives |
|---|---|---|
| usual neuroleptanalgesic treatment | Active comparator | Drug: Neuroleptanalgesia- Group 1: local anaesthesia by tumescence + neuroleptanalgesia |
| use of a device incorporating virtual reality software | Experimental | Device: use of a device incorporating virtual reality software- Group 2: local anaesthesia by tumescence with virtual reality software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of a device incorporating virtual reality softwareuse of a device incorporating virtual reality software | Device | use of a device incorporating virtual reality software |
| NeuroleptanalgesiaUsual neuroleptanalgesic treatment | Drug | usual neuroleptanalgesic treatment |
Primary outcome
Pain intensity assessed by NRS (numerical rating scale)
Time frame: Day 1
The intensity of maximum pain during the surgery will be assessed by numerical rating scale (NRS) graduated from 0 (no pain) to 10 (worst pain imaginable).
10 secondary outcomes
Level of pre-operative anxiety assessed by the patient using the STAI-Y
Time frame: Day 0
Level of post-operative anxiety assessed by the patient using the STAI-Y
Time frame: Day 1
treatment administered during the procedure
Time frame: Day 1
Pain intensity assessed by NRS (numerical rating scale)
Time frame: Day 1
Overall patient satisfaction post-opérative assessed by NRS (numerical rating scale)
Time frame: Day 0
Overall patient satisfaction day 1 assessed by NRS (numerical rating scale)
Time frame: Day 1
Surgery duration
Time frame: Day 0
Length of stay in the ICU
Time frame: Day 1
Length of stay in the hospital
Time frame: Day 1
Resumption of current activities
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Superficial Venous Insufficiency
Recruiting
Pilot Study: Evaluation of the Safety of the Application of Non-thermal HIFU for Varicose Veins Treatment of the Lower Limbs
Superficial Venous Insufficiency, Varicose Veins
Active, not recruiting
Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)
Deep Vein Thrombosis, Venous Stasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauranne MATRAY, MD principal investigator
Clinique de l'Union
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of a device incorporating virtual reality software and Neuroleptanalgesia in people with Superficial Venous Insufficiency, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauranne MATRAY, MD (05 61 37 81 81 ext. 33, dr.lmatray.union@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity assessed by NRS (numerical rating scale) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.