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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-19

Study Completion Date

2025-05-07

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treated with UNI-VEC

Group Type EXPERIMENTAL

Treatment of rectal lesions with UNI-VEC

Intervention Type DEVICE

Polyp resections

Interventions

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Treatment of rectal lesions with UNI-VEC

Polyp resections

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No