Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT01603433
Brief Summary:
This is a single center, prospective, non-randomized, feasibility study for the evaluation of safety, efficacy and performance of the Sapheon™ Closure System for the treatment of incompetent saphenous veins.
Detailed Description:
Venous insufficiency of the lower extremities is a very common condition that is influenced by genetic and mechanical factors, and is a chronic and progressive disorder. The primary objectives for this clinical Study are to
1. demonstrate the safety of the Sapheon™ Closure System for the treatment of incompetent saphenous veins,
2. demonstrate the early and late efficacy of The Sapheon™ Closure System for the treatment of incompetent saphenous veins, and
3. demonstrate the satisfactory performance of the Sapheon™ Closure System device components.
Study:
NCT01603433
Study Brief:
Protocol Section:
NCT01603433