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Acellular Tissue Engineered…
Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Patients With Extremity Arterial Injury Requiring Urgent Repair
Ensayo de Humacyte, Inc. en Lesion vascular · Lesion arterial · Lesion traumatica.
- Fase
- Fase 4
- Estado
- Aún sin reclutar
- Participantes
- 125
- Fin del objetivo primario
- sep 2030
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en sep 2026.
Qué mide
Permeabilidad secundaria de Symvess estimada por Kaplan-Meier (12 meses)
Qué se prueba
Se hace un seguimiento observacional de Symvess en la practica real en pacientes adultos con lesion arterial en una extremidad, midiendo la permeabilidad secundaria al ano.
Lo que dice el documentoThe goal of this post-marketing observational study is to further assess the long-term safety and efficacy of Symvess in a real-world setting in adult patients with extremity arterial injury. The primary objective of the study is to determine Symvess secondary patency at 1 year.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe goal of this post-marketing observational study is to further assess the long-term safety and efficacy of Symvess in a real-world setting in adult patients with extremity arterial injury. The primary objective of the study is to determine Symvess secondary patency at 1 year. Additional key secondary objectives, such as limb salvage, infection-free rate, primary patency, and safety, will also be assessed at 1 year. All participants will receive Symvess. This is an open-label study and there is no comparator. Participants will undergo surgery to repair an extremity arterial injury using Symvess. Participants will be asked to return at regular intervals up to 1 year post-implant to undergo imaging to assess Symvess patency, and for other standard clinical safety and efficacy assessments.
Más ensayos de HUMA
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Acellular Tissue Engineered… | Fase 3 | En marcha, sin reclutar | jun 2027 (prevista) |
| Acellular Tissue Engineered… | Fase 3 | Aún sin reclutar | dic 2028 (prevista) |
| Humacyte Coronary Tissue… | Fase 2 | Aún sin reclutar | sep 2030 (prevista) |
| Human Acellular Vessel | Fase 3 | Completado | abr 2024 (real) |
| Acellular Tissue Engineered… | Fase 2/3 | Completado | sep 2023 (real) |
| HAV implantation | no aplica | Completado | may 2023 (real) |
Todos los de HUMA, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT07762794), actualizada en ago 2026.