Clinical trial NCT06286956: Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device
Official title: Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rectal Polyp
Rectal Polyps
Rectal Lesion
Sessile Colonic Polyp
Pedunculated Colorectal Polyps
Keywords: First-in-human study
Transanal multi channel device
Medical Device
Lead sponsor: Vecmedical Spain, S.L.
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 outcomes:
measure: Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps
timeFrame: During the procedure
Secondary outcomes:
measure: Rate of anorectal hemorrhagic events
timeFrame: During the intervention and 1 week after the intervention.
measure: Rate of injuries to the anorectal canal and perianal region
timeFrame: During the intervention and 1 week after the intervention.
measure: Assessment of anorectal continence
timeFrame: 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.
Other outcomes:
Locations:
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
state: Asturias
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua de Terrassa
state: Bercelona
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario de A Coruña
state: Galicia
city: A Coruña
country: Spain
facility: Hospital Quirón-Salud A Coruña
state: Galicia
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
state: Galicia
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
state: Galicia
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital La Paz
city: Murcia
country: Spain
facility: Hospital Universitario Reina Sofía de Murcia
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
city: València
country: Spain
facility: Hospital Universitario La Fe
Study officials:
References:
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 abstract available.
citation: 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.