NCT06286956

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Vecmedical Spain, S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Treatment of rectal lesions with UNI-VEC	Polyp resections

Timeline

• Start date: 2021-04-19
• Primary completion: 2025-01-03
• Completion: 2025-05-07
• First posted: 2024-02-29
• Last updated: 2025-03-27

Locations

11 sites across 1 country: Spain