Rectal PolypUNI-VECNCT06286956
Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device
A study testing Treatment of rectal lesions with UNI-VEC in people with Rectal Polyp and Rectal Polyps, run by Vecmedical Spain, S.L. at 11 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Polyp, Rectal Polyps, Rectal Lesion
- What is being tested?
- Treatment of rectal lesions with UNI-VEC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 11 sitesSpain
- Study dates
- 19 Apr 2021to 7 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Complexo Hospitalario Universitario de A Coruña
A Coruña, Galicia, 15006
Hospital Quirón-Salud A Coruña
A Coruña, Galicia, 15006
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, 33394
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003
Hospital La Paz
Madrid, Madrid, 28046
Hospital Universitario Reina Sofía de Murcia
Murcia, Murcia, 30003
Hospital Universitari Mútua de Terrassa
Terrassa, Bercelona, 08221
Hospital Universitario La Fe
Valencia, València, 46026
Hospital Universitario Río Hortega
Valladolid, Valladolid, 47012
Complejo Hospitalario Universitario de Vigo
Vigo, Galicia, 36204
About this study
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
- Being tested
- Treatment of rectal lesions with UNI-VEC
- Keywords
- First-in-human study, Transanal multi channel device, Medical Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of rectal lesions with UNI-VECDevice
Polyp resections
| Study group | Role | What they receive |
|---|---|---|
| Treated with UNI-VEC | Experimental | Not described Receives: Device: Treatment of rectal lesions with UNI-VEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps
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.
Measured: During the procedure
Secondary outcomes (3)
Rate of anorectal hemorrhagic events
Anorectal hemorrhagic events for each patinet will be recorded in a table and the number of events will be counted.
Measured: During the intervention and 1 week after the intervention.
Rate of injuries to the anorectal canal and perianal region
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.
Measured: During the intervention and 1 week after the intervention.
Assessment of anorectal continence
Anorectal continence will be assesed for each Participant with the Wexner Score
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start19 Apr 2021
- Primary completion3 Jan 2025
- Study completion7 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vecmedical Spain, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286956
- Sponsor's protocol ID
- vec-pr-1901
- Acronym
- UNI-VEC
- Status last verified
- Mar 2025
- First submitted
- 12 Feb 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Publications
Noguera 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.
PubMed 35908719Noguera 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.
PubMed 36565988
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device
- ClinicalTrials.gov ID
- NCT06286956
- Acronym / sponsor ID
- UNI-VEC / vec-pr-1901
- Conditions
- Rectal Polyp, Rectal Polyps, Rectal Lesion, Sessile Colonic Polyp, Pedunculated Colorectal Polyps
- Keywords
- First-in-human study, Transanal multi channel device, Medical Device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vecmedical Spain, S.L.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 7 May 2025 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with UNI-VEC | Experimental | Device: Treatment of rectal lesions with UNI-VEC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of rectal lesions with UNI-VECPolyp resections | Device | Treated with UNI-VEC |
Primary outcome
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.
3 secondary outcomes
Rate of anorectal hemorrhagic events
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Results publication: PubMed 35908719Noguera 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.
- Results publication: PubMed 36565988Noguera 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.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of rectal lesions with UNI-VEC in people with Rectal Polyp and Rectal Polyps, run by Vecmedical Spain, S.L. at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06286956, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.