Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT05663359
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2022-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Treatment of Varicose Veins by Endovenous Laser (1940 nm vs 1470 nm)
Sponsor:
Clinique Pasteur
Organization:
Study Overview
Official Title:
Randomized Comparative Study With Two Wavelengths 1470 nm and 1940 nm for the Treatment of Varicose Veins of the Lower Limbs by Endovenous Laser.
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEWWAVE
Brief Summary:
The goal of this clinical trial is to compare efficacy of two wavelength for EndoVenous Laser Ablation (EVLA) in treatment of varicose veins of the lower limbs.
The main questions it aims to answers are :
1. Is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ?
2. Is the increase of wavelength reduce complication or pain ? Participants are patients with varicose veins of lower limbs and candidate for endovenous laser ablation.
After laser ablation patients will be followed during 5 years for clinical evaluation, recording potential treatment complications and quality of life evaluation.
Researchers will compare strategy 1(EVLA with an endovenous laser at 1940 nm) vs strategy 2 (EVLA with an endovenous laser at 1470 nm) in varicose veins treatment to see if efficacy of treatment is not reduce, and to see if complications of EVLA treatment can be reduced.
The main questions it aims to answers are :
1. Is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ?
2. Is the increase of wavelength reduce complication or pain ? Participants are patients with varicose veins of lower limbs and candidate for endovenous laser ablation.
After laser ablation patients will be followed during 5 years for clinical evaluation, recording potential treatment complications and quality of life evaluation.
Researchers will compare strategy 1(EVLA with an endovenous laser at 1940 nm) vs strategy 2 (EVLA with an endovenous laser at 1470 nm) in varicose veins treatment to see if efficacy of treatment is not reduce, and to see if complications of EVLA treatment can be reduced.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: