Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 5:08 AM
Study NCT ID:
NCT03050333
Status:
UNKNOWN
Last Update Posted:
2017-02-10
First Post:
2017-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Endoscopic Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2017-02-03', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of complete resections without recurrence', 'timeFrame': '6 month post-endoscopic resection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endoscopic Resection', 'Gastrointestinal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '31655045', 'type': 'DERIVED', 'citation': 'Albeniz E, Gimeno-Garcia AZ, Fraile M, Ibanez B, Guarner-Argente C, Alonso-Aguirre P, Alvarez MA, Gargallo CJ, Pellise M, Ramos Zabala F, Herreros de Tejada A, Nogales O, Martinez-Ares D, Mugica F, de la Pena J, Espinos J, Huerta A, Alvarez A, Gonzalez-Santiago JM, Navajas F, Martinez-Cara JG, Redondo-Cerezo E, Merlo Mas J, Sabado F, Rivero L, Saperas E, Soto S, Rodriguez-Sanchez J, Lopez-Roses L, Rodriguez-Tellez M, Rullan Iriarte M, Elosua Gonzalez A, Pardeiro R, Valdivielso Cortazar E, Concepcion-Martin M, Huelin Alvarez P, Colan Hernandez J, Cobian J, Santiago J, Jimenez A, Remedios D, Lopez-Viedma B, Garcia O, Martinez-Alcala F, Perez-Roldan F, Carbo J, Enguita M. Clinical validation of risk scoring systems to predict risk of delayed bleeding after EMR of large colorectal lesions. Gastrointest Endosc. 2020 Apr;91(4):868-878.e3. doi: 10.1016/j.gie.2019.10.013. Epub 2019 Oct 23.'}], 'seeAlsoLinks': [{'url': 'http://navarrabiomed.es', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'An observational, prospective, multicentre and international study. This will be a non-interventional study to evaluate the efficacy and safety of endoscopic resection of gastrointestinal lesions and to determine what are the factors related to complications, and to describe these lesions according to the different morphologic and histologic classifications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a clinical indication for endoscopic resection at the different participating centers will be consecutively included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male patients who are at least 18 years old.\n* Clinical indication for endoscopic exam and endoscopic resection\n* Patients must freely accept their involvement in this study. They shall give a written informed consent\n\nExclusion Criteria:\n\n* Patients who do not desire to be included in this study'}, 'identificationModule': {'nctId': 'NCT03050333', 'briefTitle': 'Efficacy and Safety of Endoscopic Resection', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Miguel Servet'}, 'officialTitle': 'Efficacy and Safety of Endoscopic Resection', 'orgStudyIdInfo': {'id': 'ALB-RME-2013-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'EDUARDO ALBENIZ, MD', 'role': 'CONTACT', 'email': 'edualbeniz@hotmail.com'}, {'name': 'FERRAN CAPDEVILA, PHARMD', 'role': 'CONTACT', 'email': 'fcapdevb@navarra.es'}, {'name': 'EDUARDO ALBENIZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eduardo Albeniz Arbizu', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'centralContacts': [{'name': 'EDUARDO ALBENIZ, MD', 'role': 'CONTACT', 'email': 'edualbeniz@hotmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EDUARDO ALBENIZ', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundacion Miguel Servet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'EDUARDO ALBENIZ', 'investigatorAffiliation': 'Fundacion Miguel Servet'}}}}