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

February 23, 2024 updated by: Vecmedical Spain, S.L.
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Principal Investigator:
          • Marta Jiménez, Medicine
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital La Paz
        • Principal Investigator:
          • Mario Álvarez, Medicine
      • Murcia, Spain, 30003
        • Recruiting
        • Hospital Universitario Reina Sofía de Murcia
        • Principal Investigator:
          • Pedro Parra, Medicine
      • Valladolid, Spain, 47012
        • Recruiting
        • Hospital Universitario Río Hortega
        • Principal Investigator:
          • Javier Sánchez, Medicine
      • València, Spain, 46026
        • Recruiting
        • Hospital Universitario La Fe
        • Principal Investigator:
          • Blas Flor, Medicine
    • Asturias
      • Gijón, Asturias, Spain, 33394
        • Recruiting
        • Hospital Universitario de Cabueñes
        • Principal Investigator:
          • Carlos Álvarez, Medicine
    • Bercelona
      • Terrassa, Bercelona, Spain, 08221
        • Recruiting
        • Hospital Universitari Mutua de Terrassa
        • Principal Investigator:
          • Salvadora Delgado, Medicine
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Recruiting
        • Complexo Hospitalario Universitario de A Coruña
        • Contact:
        • Principal Investigator:
          • José F Noguera, Medicine
      • A Coruña, Galicia, Spain, 15006
        • Recruiting
        • Hospital Quirón-Salud A Coruña
        • Principal Investigator:
          • Alba Gómez, Medicine
      • Lugo, Galicia, Spain, 27003
        • Recruiting
        • Hospital Universitario Lucus Augusti
        • Principal Investigator:
          • Olga Maseda, Medicine
      • Vigo, Galicia, Spain, 36204
        • Recruiting
        • Complejo Hospitalario Universitario de Vigo
        • Principal Investigator:
          • Raquel Sánchez, Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated with UNI-VEC
Device: Treatment of rectal lesions with UNI-VEC
Polyp resections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the intervention and 1 week after the intervention.
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.
During the intervention and 1 week after the intervention.
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vecmedical Spain, S.L.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2021

Primary Completion (Estimated)

May 7, 2024

Study Completion (Estimated)

September 7, 2024

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vec-pr-1901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD collected throughout the trial

IPD Sharing Time Frame

Beginning 1 year after publication with no end date

IPD Sharing Access Criteria

A proposal that describes planned analyses must be submitted, and a data sharing agreement must be signed. The documents could be sent by email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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