Pedunculated Colorectal Polyps, Rectal Lesion, Rectal Polyp, Rectal Polyps, Sessile Colonic Polyp
Conditions
Keywords
First-in-human study, Transanal multi channel device, Medical Device
Brief 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).
Interventions
DEVICETreatment of rectal lesions with UNI-VEC
Polyp resections
Sponsors
Vecmedical Spain, S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of anorectal hemorrhagic events | 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. |
| Rate of injuries to the anorectal canal and perianal region | 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. |
| Assessment of anorectal continence | 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 |
Countries
Spain
Outcome results
None listed