NCT06286956Active, not recruiting
Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device
Source: ClinicalTrials.gov · Last updated 27 Mar 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 12 Feb 2024
- Start date
- 19 Apr 2021
- Primary completion date
- 3 Jan 2025
- Lead sponsor
- Vecmedical Spain, S.L.
- Diseases
- Colorectal cancer
- NCT number
- NCT06286956
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 19 Apr 2021 to the primary completion date, 3 Jan 2025
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- Are considered vulnerable subjects.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complexo Hospitalario Universitario de A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Quirón-Salud A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Unknown status |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Hospital La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Reina Sofía de Murcia Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital Universitari Mútua de Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Unknown status |
| Hospital Universitario la Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario Rio Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Complejo Hospitalario Universitario de Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.