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

Vecmedical

Status: Enrolling

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

Treatments: Device: Treatment of rectal lesions with UNI-VEC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06286956

vec-pr-1901

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Treated with UNI-VEC

Experimental group

Treatment:

Device: Treatment of rectal lesions with UNI-VEC