Saphenous Vein InjuryIPV-1940NCT07629843
Patient Satisfaction, Safety, and Efficacy of Endovenous Laser Treatment for Saphenous Veins and Varicose Veins
An observational study of Saphenous Vein Injury, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
Trial summary
The purpose of this study is to evaluate the post-operative patient satisfaction on the treatment of saphenous veins and varicose veins outside the operating theater under strict local anesthesia with a 1940 nm laser via the Venous Treatment Satisfaction Questionnaire early. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Saphenous Vein Injury
- What is being tested?
- Endovenous laser ablation of the primary or recurrent saphenous vein
- Type of treatment
- Surgery or procedure
- How many people
- 155 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Oct 2026to Jun 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: The study population will be composed of adult patients receiving routine care for Endovenous Laser Ablation of primary or recurrent saphenous vein (great saphenous vein, small saphenous vein or anterior saphenous vein) outside the operating theater under strict local anesthesia.
Who may be able to join
- Age ≥ 18 years.
- Endovenous Laser Ablation of a common or recurrent saphenous vein as part of routine care.
- Clinical, Etiology, Anatomy, Pathophysiology, classification clinical stage.
- Ability to understand the study objectives and complete questionnaires in French.
- Patient has been informed and has verbally indicated their non-opposition to participating in the research.
Who cannot join
- Endovenous Laser Ablation not feasible for technical reasons, particularly if the vein is too "bent" or there are endoluminal obstacles.
- Episode of deep vein thrombosis less than 3 months ago or of superficial vein thrombosis less than 6 weeks ago.
- Active cancer.
- Geographical distance incompatible with study follow-up, according to the investigator's judgment.
- Patients currently participating or having participated in research within the previous 3 months.
- Persons covered by articles L1121-5 to L1121-8 of the French Public Health Code (corresponds to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).
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
Institut de Pathologie Vasculaire - Hôpital Privé Geoffroy Saint-Hilaire
Paris, 75005
Claudine HAMEL-DESNOS, MD, claudine.hamel-desnos@wanadoo.fr
- Recruiting
Clinique de la Muette
Paris, 75116
Anne-Sophie LENSEL, MD
About this study
Official title: Patient Satisfaction, Safety and Efficacy of Treatment for Saphenous Veins and Varicose Veins Outside the Operating Theater Under Strict Local Anesthesia With 1940nm Endovenous Laser: a Prospective Multicenter Observational Study
The purpose of this study is to evaluate the post-operative patient satisfaction on the treatment of saphenous veins and varicose veins outside the operating theater under strict local anesthesia with a 1940 nm laser via the Venous Treatment Satisfaction Questionnaire early.
Read the detailed description
This is a non-interventional, prospective, non-randomized, descriptive, and multicenter study.
The study will be conducted by vascular physicians practicing at the Institute of Vascular Pathology of the Geoffroy Saint-Hilaire Private Hospital or La Muette Clinic (Paris).
The study population will be composed of adult patients receiving routine care for Endovenous Laser Ablation of primary or recurrent saphenous vein (great saphenous vein, small saphenous vein or anterior saphenous vein) outside the operating theater under strict local anesthesia.
- Conditions
- Saphenous Vein Injury
- Being tested
- Endovenous laser ablation of the primary or recurrent saphenous vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovenous laser ablation of the primary or recurrent saphenous veinProcedure or surgery
Treatment of saphenous veins and varicose veins performed outside the operating room strictly under local anesthesia with a 1940 nm laser.
| Study group | Role | What they receive |
|---|---|---|
| Primary or recurrent saphenous vein | Patients receiving routine care for endovenous laser ablation of the primary or recurrent saphenous vein (great saphenous vein, small saphenous vein or anterior saphenous vein) Receives: Procedure: Endovenous laser ablation of the primary or recurrent saphenous vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Treatment Satisfaction Questionnaire early score
Evaluate the post-operative patient satisfaction on the treatment of saphenous veins and varicose veins outside the operating theater under strict local anesthesia with a 1940 nm laser via the Venous Treatment Satisfaction Questionnaire early.
Scale from 0 to 6 (a high score indicates a positive result).
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Oct 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Saphenous Vein InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629843
- Sponsor's protocol ID
- 2026-A00763-48
- Acronym
- IPV-1940
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction, Safety and Efficacy of Treatment for Saphenous Veins and Varicose Veins Outside the Operating Theater Under Strict Local Anesthesia With 1940nm Endovenous Laser: a Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT07629843
- Acronym / sponsor ID
- IPV-1940 / 2026-A00763-48
- Conditions
- Saphenous Vein Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 5 Jun 2026 (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.
The purpose of this study is to evaluate the post-operative patient satisfaction on the treatment of saphenous veins and varicose veins outside the operating theater under strict local anesthesia with a 1940 nm laser via the Venous Treatment Satisfaction Questionnaire early.
Detailed description
This is a non-interventional, prospective, non-randomized, descriptive, and multicenter study.
The study will be conducted by vascular physicians practicing at the Institute of Vascular Pathology of the Geoffroy Saint-Hilaire Private Hospital or La Muette Clinic (Paris).
The study population will be composed of adult patients receiving routine care for Endovenous Laser Ablation of primary or recurrent saphenous vein (great saphenous vein, small saphenous vein or anterior saphenous vein) outside the operating theater under strict local anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary or recurrent saphenous vein | – | Procedure: Endovenous laser ablation of the primary or recurrent saphenous veinPatients receiving routine care for endovenous laser ablation of the primary or recurrent saphenous vein (great saphenous vein, small saphenous vein or anterior saphenous vein) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of adult patients receiving routine care for Endovenous Laser Ablation of primary or recurrent saphenous vein (great saphenous vein, small saphenous vein or anterior saphenous vein) outside the operating theater under strict local anesthesia.
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Endovenous Laser Ablation of a common or recurrent saphenous vein as part of routine care.
- Clinical, Etiology, Anatomy, Pathophysiology, classification clinical stage.
- Ability to understand the study objectives and complete questionnaires in French.
- Patient has been informed and has verbally indicated their non-opposition to participating in the research.
Key exclusion criteria (6 listed)
- Endovenous Laser Ablation not feasible for technical reasons, particularly if the vein is too "bent" or there are endoluminal obstacles.
- Episode of deep vein thrombosis less than 3 months ago or of superficial vein thrombosis less than 6 weeks ago.
- Active cancer.
- Geographical distance incompatible with study follow-up, according to the investigator's judgment.
- Patients currently participating or having participated in research within the previous 3 months.
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 |
|---|---|---|
| Endovenous laser ablation of the primary or recurrent saphenous veinTreatment of saphenous veins and varicose veins performed outside the operating room strictly under local anesthesia with a 1940 nm laser. | Procedure or surgery | Primary or recurrent saphenous vein |
Primary outcome
Venous Treatment Satisfaction Questionnaire early score
Time frame: 12 days
Evaluate the post-operative patient satisfaction on the treatment of saphenous veins and varicose veins outside the operating theater under strict local anesthesia with a 1940 nm laser via the Venous Treatment Satisfaction Questionnaire early. Scale from 0 to 6 (a high score indicates a positive result).
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 16 Oct 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Saphenous Vein Injury, 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 5 inclusion and 6 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 16 Oct 2026. 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 Claudine HAMEL-DESNOS, MD (144085838 ext. +33, claudine.hamel-desnos@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous Treatment Satisfaction Questionnaire early score (time frame: 12 days). 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 16 Oct 2026.