Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-31 @ 3:52 PM
Study NCT ID:
NCT06669260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating QoL and Postoperative Complications Using TEThA Technique in the Treatment of Tributary Veins
Sponsor:
Nara Medeiros Cunha de Melo Vasconcelos
Organization:
Study Overview
Official Title:
Prospective Study to Evaluate QoL Scores and Post-operative Complications Using TEThA (Transfixing Endovenous Thermal Ablation) Technique in Tributary Veins Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
TEThA
Brief Summary:
Endovenous laser thermoablation is a well-established alternative for the treatment of tributary veins. We believe that it is possible to improve the techniques described in the literature, aiming not only to allocate the laser fiber within the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation).
Detailed Description:
Endovenous laser thermoablation is an alternative for the treatment of tributary veins that is not yet one of the main alternatives in our specialty's consensus. In order to treat tributary veins applying laser, several punctures and the complete placement of introducer catheters are recommended in order to position the endolaser fiber in the lumen of the varicose vein before performing thermoablation of the saphenous veins. However, we believe that it is possible to perform an adequate treatment with a smaller number of punctures, aiming not only to place the laser fiber inside the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation). Our aim is to carry out a prospective cohort study to assess the Aberdeen score in patients undergoing the TEThA technique for the treatment of tributary veins.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: