protocolSection identificationModule nctId: NCT06286956, orgStudyIdInfo id: vec-pr-1901, briefTitle: Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device, acronym: UNI-VEC, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-19, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-09-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Vecmedical Spain, S.L., class: INDUSTRY, 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)., conditionsModule conditions: Rectal Polyp, conditions: Rectal Polyps, conditions: Rectal Lesion, conditions: Sessile Colonic Polyp, conditions: Pedunculated Colorectal Polyps, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Treatment of rectal lesions with UNI-VEC, outcomesModule primaryOutcomes measure: Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps, secondaryOutcomes measure: Rate of anorectal hemorrhagic events, secondaryOutcomes measure: Rate of injuries to the anorectal canal and perianal region, secondaryOutcomes measure: Assessment of anorectal continence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario de Cabueñes, status: RECRUITING, city: Gijón, state: Asturias, zip: 33394, country: Spain, contacts name: Carlos Álvarez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.53573, lon: -5.66152, locations facility: Hospital Universitari Mútua de Terrassa, status: RECRUITING, city: Terrassa, state: Bercelona, zip: 08221, country: Spain, contacts name: Salvadora Delgado, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.56667, lon: 2.01667, locations facility: Complexo Hospitalario Universitario de A Coruña, status: RECRUITING, city: A Coruña, state: Galicia, zip: 15006, country: Spain, contacts name: José F Noguera, Medicin, role: CONTACT, phone: +34 981178049, email: jose.francisco.noguera.aguilar@sergas.es, contacts name: José F Noguera, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.37135, lon: -8.396, locations facility: Hospital Quirón-Salud A Coruña, status: RECRUITING, city: A Coruña, state: Galicia, zip: 15006, country: Spain, contacts name: Alba Gómez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.37135, lon: -8.396, locations facility: Hospital Universitario Lucus Augusti, status: RECRUITING, city: Lugo, state: Galicia, zip: 27003, country: Spain, contacts name: Olga Maseda, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.00992, lon: -7.55602, locations facility: Complejo Hospitalario Universitario de Vigo, status: RECRUITING, city: Vigo, state: Galicia, zip: 36204, country: Spain, contacts name: Raquel Sánchez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.23282, lon: -8.72264, locations facility: Hospital del Mar, status: RECRUITING, city: Barcelona, zip: 08003, country: Spain, contacts name: Marta Jiménez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital La Paz, status: RECRUITING, city: Madrid, zip: 28046, country: Spain, contacts name: Mario Álvarez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Reina Sofía de Murcia, status: RECRUITING, city: Murcia, zip: 30003, country: Spain, contacts name: Pedro Parra, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98704, lon: -1.13004, locations facility: Hospital Universitario Río Hortega, status: RECRUITING, city: Valladolid, zip: 47012, country: Spain, contacts name: Javier Sánchez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.65518, lon: -4.72372, locations facility: Hospital Universitario La Fe, status: RECRUITING, city: València, zip: 46026, country: Spain, contacts name: Blas Flor, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False