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

NCT06286956 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-27

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

DEVICE

Treatment of rectal lesions with UNI-VEC

Polyp resections

Sponsors & Collaborators

  • Vecmedical Spain, S.L.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2025-01-03
Completion
2025-05-07

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06286956 on ClinicalTrials.gov