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Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device
Sponsor: Vecmedical Spain, S.L.
Summary
The aim of the clinical trial is to investigate whether the use of a new multichannel endoscopic transanal access device (named UNI-VEC) is safe and effective in the resection of a rectal polyp or tumor that sits in the distal part of the colon (up to about 20 cm from the anal margin). This is the first study to test the device in humans, after proving its good performance in preclinical development (preclinical development has included functional laboratory tests and an animal trial).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2021-04-19
Completion Date
2025-05-07
Last Updated
2025-03-27
Healthy Volunteers
No
Interventions
Treatment of rectal lesions with UNI-VEC
Polyp resections
Locations (11)
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Universitari Mútua de Terrassa
Terrassa, Bercelona, Spain
Complexo Hospitalario Universitario de A Coruña
A Coruña, Galicia, Spain
Hospital Quirón-Salud A Coruña
A Coruña, Galicia, Spain
Hospital Universitario Lucus Augusti
Lugo, Galicia, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, Galicia, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital Universitario Reina Sofía de Murcia
Murcia, Murcia, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Universitario Río Hortega
Valladolid, Valladolid, Spain
Hospital Universitario La Fe
Valencia, València, Spain