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