Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06286956
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-27
First Post:
2024-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-23', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'measure': 'Rate of anorectal hemorrhagic events', 'timeFrame': 'During the intervention and 1 week after the intervention.', 'description': 'Anorectal hemorrhagic events for each patinet will be recorded in a table and the number of events will be counted.'}, {'measure': 'Rate of injuries to the anorectal canal and perianal region', 'timeFrame': 'During the intervention and 1 week after the intervention.', 'description': '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.'}, {'measure': 'Assessment of anorectal continence', 'timeFrame': '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.', 'description': 'Anorectal continence will be assesed for each Participant with the Wexner Score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['First-in-human study', 'Transanal multi channel device', 'Medical Device'], 'conditions': ['Rectal Polyp', 'Rectal Polyps', 'Rectal Lesion', 'Sessile Colonic Polyp', 'Pedunculated Colorectal Polyps']}, 'referencesModule': {'references': [{'pmid': '35908719', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36565988', 'type': 'BACKGROUND', 'citation': 'Noguera 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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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))\n* Lesions located from the anal margin to about 20 cm.\n* Extent of at least 2 cm² (polyps 2 cm in diameter or areas of ERM or ESD 2 x 2 cm).\n* Well or moderately differentiated tumours. T1: Tumours confined to the mucosa (Tis) and submucosa (T1).\n* No positive lymph nodes.\n* No lymphatic, vascular or perineural invasion.\n\nExclusion Criteria:\n\n* Are considered vulnerable subjects.\n* 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).\n* Have rectal lesions that lie above the pectineal line or extend into the anal canal.\n* Local or distant metastasis.\n* Have a score of more than 2 points on the Wexner faecal incontinence scale.'}, 'identificationModule': {'nctId': 'NCT06286956', 'acronym': 'UNI-VEC', 'briefTitle': 'Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vecmedical Spain, S.L.'}, 'officialTitle': 'Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device', 'orgStudyIdInfo': {'id': 'vec-pr-1901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated with UNI-VEC', 'interventionNames': ['Device: Treatment of rectal lesions with UNI-VEC']}], 'interventions': [{'name': 'Treatment of rectal lesions with UNI-VEC', 'type': 'DEVICE', 'description': 'Polyp resections', 'armGroupLabels': ['Treated with UNI-VEC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Bercelona', 'country': 'Spain', 'facility': 'Hospital Universitari Mútua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario de A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Hospital Quirón-Salud A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '27003', 'city': 'Lugo', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Hospital Universitario Lucus Augusti', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '36204', 'city': 'Vigo', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30003', 'city': 'Murcia', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía de Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '33394', 'city': 'Gijón', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hospital Universitario de Cabueñes', 'geoPoint': {'lat': 43.53573, 'lon': -5.66152}}, {'zip': '47012', 'city': 'Valladolid', 'state': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Universitario Río Hortega', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '46026', 'city': 'Valencia', 'state': 'València', 'country': 'Spain', 'facility': 'Hospital Universitario La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Beginning 1 year after publication with no end date', 'ipdSharing': 'YES', 'description': 'All IPD collected throughout the trial', 'accessCriteria': 'A proposal that describes planned analyses must be submitted, and a data sharing agreement must be signed. The documents could be sent by email.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vecmedical Spain, S.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}