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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment of rectal lesions with UNI-VEC

Device

Polyp resections

Primary outcomes

Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps

Time frame: 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.

Secondary outcomes

Rate of anorectal hemorrhagic events

Time frame: During the intervention and 1 week after the intervention.

Anorectal hemorrhagic events for each patinet will be recorded in a table and the number of events will be counted.
Rate of injuries to the anorectal canal and perianal region

Time frame: During the intervention and 1 week after the intervention.

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.
Assessment of anorectal continence

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.

Anorectal continence will be assesed for each Participant with the Wexner Score

Sponsors and collaborators

Lead sponsor

Vecmedical Spain, S.L.

Industry

Registry information

Acronym: UNI-VEC

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Feb 29, 2024
Registry last updated: Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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