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

Rectal Polyp Clinical Trial

— UNI-VEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286956
• Other study ID #: vec-pr-1901
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: September 7, 2024

Study information

• Verified date: February 2024
• Source: Vecmedical Spain, S.L.
• Contact: Ariadna Camps, Biomedical engineering
• Phone: +34 935725015
• Email: ariadna.camps[@]vecmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 7, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps
• Rectal Lesion
• Rectal Neoplasms
• Rectal Polyp
• Rectal Polyps
• Sessile Colonic Polyp

Intervention

Device:
• Treatment of rectal lesions with UNI-VEC
Polyp resections

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario de A Coruña	A Coruña	Galicia
Spain	Hospital Quirón-Salud A Coruña	A Coruña	Galicia
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario de Cabueñes	Gijón	Asturias
Spain	Hospital Universitario Lucus Augusti	Lugo	Galicia
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario Reina Sofía de Murcia	Murcia
Spain	Hospital Universitari Mútua de Terrassa	Terrassa	Bercelona
Spain	Hospital Universitario La Fe	València
Spain	Hospital Universitario Río Hortega	Valladolid
Spain	Complejo Hospitalario Universitario de Vigo	Vigo	Galicia

Sponsors (1)

Lead Sponsor	Collaborator
Vecmedical Spain, S.L.

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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, — View Citation

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 abst — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	During the intervention and 1 week after the intervention.
Secondary	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.	During the intervention and 1 week after the intervention.
Secondary	Assessment of anorectal continence	Anorectal continence will be assesed for each Participant with the Wexner Score	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.