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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Polyp resections
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
...and 1 more locations
Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps
The device must allow the removal of polyps with a minimum size of 2 cm (maximum diameter of the removed polyp measured in mm) in the rectum.
Time frame: During the procedure
Rate of anorectal hemorrhagic events
Anorectal hemorrhagic events for each patinet will be recorded in a table and the number of events will be counted.
Time frame: During the intervention and 1 week after the intervention.
Rate of injuries to the anorectal canal and perianal region
The number of injuries to the anorectal canal and perianal region will be recoreded in a table and then the total number of injuries will be counted.
Time frame: During the intervention and 1 week after the intervention.
Assessment of anorectal continence
Anorectal continence will be assesed for each Participant with the Wexner Score
Time frame: At 7 and 30 days after the procedure. If anorectal incontinence persists at 30 days: follow-up at 2 months. If anorectal incontinence persists: follow-up at 6 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.