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Clinical Trials in Spain / NCT06286956
Active, not recruiting Not applicable

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

NCT06286956 · tracked via the Priya Life Science Spain tracker
Sponsor
Vecmedical Spain, S.L
Phase
Not applicable
Started
2021-04-19
Last updated
2025-03-27

Condition(s) studied

Rectal PolypRectal PolypsRectal LesionSessile Colonic PolypPedunculated Colorectal Polyps

Investigational drug(s) / intervention(s)

Treatment of rectal lesions with UNI-VEC

Treatment of rectal lesions with UNI-VEC: Polyp resections

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * All polyps included in the Paris Classification (Polypoid (0-I): Sessile type (Is), Pedunculated type (Ip), Non-polypoid (0-II, III): Raised type (IIa), Flat type (IIb), Depressed type (IIc), Excavated type (III)) * Lesions located from the anal margin to about 20 cm. * Extent of at least 2 cm² (polyps 2 cm in diameter or areas of ERM or ESD 2 x 2 cm). * Well or moderately differentiated tumours. T1: Tumours confined to the mucosa (Tis) and submucosa (T1). * No positive lymph nodes. * No lymphatic, vascular or perineural invasion. Exclusion Criteria: * Are considered vulnerable subjects. * They suffer from hematological diseases with altered coagulation of their own or pharmacologically induced coagulation disorders (the use of acetylsalicylic acid (ASA) in doses of 150 mg/day is permitted). * Have rectal lesions that lie above the pectineal line or extend into the anal canal. * Local or distant metastasis. * Have a score of more than 2 points on the Wexner faecal incontinence scale.

Primary outcome measure(s)

  • Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps — During the procedure
    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.

Trial sites (11)

FacilityCityRegionStatus
Hospital del Mar Barcelona Barcelona
Hospital Universitari Mútua de Terrassa Terrassa Bercelona
Complexo Hospitalario Universitario de A Coruña A Coruña Galicia
Hospital Quirón-Salud A Coruña A Coruña Galicia
Hospital Universitario Lucus Augusti Lugo Galicia
Complejo Hospitalario Universitario de Vigo Vigo Galicia
Hospital La Paz Madrid Madrid
Hospital Universitario Reina Sofía de Murcia Murcia Murcia
Hospital Universitario de Cabueñes Gijón Principality of Asturias
Hospital Universitario Río Hortega Valladolid Valladolid
Hospital Universitario La Fe Valencia València
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06286956 on ClinicalTrials.gov ↗ ← All trials in Spain