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

NCT06286956 | Active Not Recruiting DMC

• 1 other identifier: vec-pr-1901
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 11

Brief 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).

Conditions

Rectal Polyp; Rectal Polyps; Rectal Lesion; Sessile Colonic Polyp; Pedunculated Colorectal Polyps

Keywords

First-in-human study; Transanal multi channel device; Medical Device

Outcome Measures

Primary Outcomes (1)

• 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.

  During the procedure

Secondary Outcomes (3)

• Rate of anorectal hemorrhagic events

  During the intervention and 1 week after the intervention.

• Rate of injuries to the anorectal canal and perianal region

  During the intervention and 1 week after the intervention.

• Assessment of anorectal continence

  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.

Study Arms (1)

Treated with UNI-VEC

EXPERIMENTAL

Device: Treatment of rectal lesions with UNI-VEC

Interventions

Treatment of rectal lesions with UNI-VEC DEVICE

Polyp resections

Treated with UNI-VEC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vecmedical Spain, S.L.: lead

Study Sites (11)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital Universitari Mútua de Terrassa

Terrassa, Bercelona, 08221, Spain

Location

Complexo Hospitalario Universitario de A Coruña

A Coruña, Galicia, 15006, Spain

Location

Hospital Quirón-Salud A Coruña

A Coruña, Galicia, 15006, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Galicia, 27003, Spain

Location

Complejo Hospitalario Universitario de Vigo

Vigo, Galicia, 36204, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Universitario Reina Sofía de Murcia

Murcia, Murcia, 30003, Spain

Location

Hospital Universitario de Cabueñes

Gijón, Principality of Asturias, 33394, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Valladolid, 47012, Spain

Location

Hospital Universitario La Fe

Valencia, València, 46026, Spain

Location

Related Publications (2)

• Noguera Aguilar JF, Gomez Dovigo A, Alonso Aguirre P, Gonzalez Conde B. Endoscopic submucosal dissection transanal hybrid laparoendoscopic robot-assisted. Cir Esp (Engl Ed). 2023 Apr;101(4):291. doi: 10.1016/j.cireng.2022.07.016. Epub 2022 Jul 28. No abstract available.

  PMID: 35908719 BACKGROUND

• Noguera Aguilar JF, Gomez Dovigo A, Aguirrezabalaga Gonzalez J, Gonzalez Conde B, Alonso Aguirre P, Martinez Ares D, Sanchez Gonzalez J, Diez Redondo MP, Maseda Diaz O, Torres Garcia MI, Dacal Rivas A, Delgado Rivilla S, Romero Marcos JM, Ramirez Ruiz P, de Maria Pallares P, Alvarez Gallego M, Gomez Besteiro I. Multicenter clinical trial for the resection of rectal polyps using a new laparoendoscopic hybrid transanal access device. Cir Esp (Engl Ed). 2023 Jun;101(6):435-444. doi: 10.1016/j.cireng.2022.12.001. Epub 2022 Dec 21.

  PMID: 36565988 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 29, 2024
• Study Start: April 19, 2021
• Primary Completion: January 3, 2025
• Study Completion: May 7, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 1 year after publication with no end date
• Access Criteria: A proposal that describes planned analyses must be submitted, and a data sharing agreement must be signed. The documents could be sent by email.

Locations

ES (11)