Clinical trial · Interventional
Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device
NCT06286956CI-TRIAL-00087766UNI-VECactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pedunculated Colorectal Polyps | — | UNRESOLVED | — |
| Rectal Lesion | — | UNRESOLVED | — |
| Rectal Polyp | — | UNRESOLVED | — |
| Rectal Polyps | — | UNRESOLVED | — |
| Sessile Colonic Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment of rectal lesions with UNI-VEC | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treated with UNI-VEC
- interventionNames
- Device: Treatment of rectal lesions with UNI-VEC
Primary outcomes (1)
- measure
- Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps
- timeFrame
- During the procedure
- description
- 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.
Secondary outcomes (3)
- measure
- Rate of anorectal hemorrhagic events
- timeFrame
- During the intervention and 1 week after the intervention.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTNoguera Aguilar JF, Gomez Dovigo A, Alonso Aguirre P, Gonzalez Conde B. Endoscopic submucosal dissection transanal hybrid laparoendoscopic robot-assisted. Cir Esp (Engl Ed). 2023 Apr;101(4):291. doi: 10.1016/j.cireng.2022.07.016. Epub 2022 Jul 28. No abstract available. PMID 35908719
- RESULTNoguera Aguilar JF, Gomez Dovigo A, Aguirrezabalaga Gonzalez J, Gonzalez Conde B, Alonso Aguirre P, Martinez Ares D, Sanchez Gonzalez J, Diez Redondo MP, Maseda Diaz O, Torres Garcia MI, Dacal Rivas A, Delgado Rivilla S, Romero Marcos JM, Ramirez Ruiz P, de Maria Pallares P, Alvarez Gallego M, Gomez Besteiro I. Multicenter clinical trial for the resection of rectal polyps using a new laparoendoscopic hybrid transanal access device. Cir Esp (Engl Ed). 2023 Jun;101(6):435-444. doi: 10.1016/j.cireng.2022.12.001. Epub 2022 Dec 21. PMID 36565988