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ACTIVE NOT RECRUITING
NCT06286956
NA

Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device

Sponsor: Vecmedical Spain, S.L.

View on ClinicalTrials.gov

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

DEVICE

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