Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT01698827
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2012-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-29', 'studyFirstSubmitDate': '2012-09-22', 'studyFirstSubmitQcDate': '2012-09-29', 'lastUpdatePostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of previous tube changes', 'timeFrame': '6 months', 'description': 'Tube outcome will be analyzed in the light of number of previous tube changes in the patients (first tube/no previous change vs. patients on long-term treatment with multiple tube changes)'}], 'primaryOutcomes': [{'measure': 'Tube durability', 'timeFrame': '6 months', 'description': 'Durability of the tube will be calculated as days in use till need for replacement, within the time frame of 6 months of observation. 180 days of continuous use will correspond to 100% durability, and 18 days of use as 10% durability.'}], 'secondaryOutcomes': [{'measure': 'Tube rupture', 'timeFrame': '6 months', 'description': 'Causes for replacement within the 6 months will be documented, with emphasis on tube or ballooon rupture'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gastrostomy', 'tube', 'endoscopic', 'replacement', 'tube rupture', 'durability', 'tube loss', 'balloon rupture'], 'conditions': ['Gastrostomy Tube Rupture', 'Gastrostomy Tube Durability', 'Gastrostomy Tube Convenience']}, 'referencesModule': {'references': [{'pmid': '21429018', 'type': 'BACKGROUND', 'citation': 'Campoli P, Cardoso D, Turchi M, Mota O. Clinical trial: a randomized study comparing the durability of silicone and latex percutaneous endoscopic gastrostomy tubes. Dig Endosc. 2011 Apr;23(2):135-9. doi: 10.1111/j.1443-1661.2010.01051.x. Epub 2010 Dec 7.'}, {'pmid': '23672806', 'type': 'DERIVED', 'citation': 'Villela EL, Sakai P, Almeida MR, Moura EG, Faintuch J. Endoscopic gastrostomy replacement tubes: long-term randomized trial with five silicone commercial models. Clin Nutr. 2014 Apr;33(2):221-5. doi: 10.1016/j.clnu.2013.04.015. Epub 2013 Apr 30.'}]}, 'descriptionModule': {'briefSummary': 'Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each. Tube performance will be observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design and material will influence outcome.', 'detailedDescription': 'Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each,in patients submitted to long-term outpatient nutritional support. Tube performance will be observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design and material will influence outcome.This study is important because tube dysfunction and unscheduled changes are expensive troubles that disrupt the nutritional protocol and are responsible for multiple inconveniences to the patient and the caretaker.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults on long-term nutritional care requiring prolonged gastrostomy feeding via percutaneous endoscopic gastrostomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults undergoing long-term home enteral nutrition via percutaneous endoscopic gastrostomy due to neurologic conditions or dysphagia.\n* registered at the outpatient endoscopy service\n* clinical stable and with the possibility of returning for scheduled visits\n* expected duration of enteral feeding \\> 6 months\n\nExclusion Criteria:\n\n* Sepsis,\n* shock,\n* coma,\n* other types of digestive access (surgical gastrostomy, jejunostomy)\n* terminal disease,\n* lack of cooperation,\n* refusal to participate in the protocol'}, 'identificationModule': {'nctId': 'NCT01698827', 'briefTitle': 'Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models', 'orgStudyIdInfo': {'id': 'Gastrotubes5A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kangaroo', 'description': '20 patients managed by "Kangaroo" gastrostomy tubes. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.', 'interventionNames': ['Other: Tube assessment visits']}, {'label': 'Cook', 'description': '20 patients receiving "Wilson Cook" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.', 'interventionNames': ['Other: Tube assessment visits']}, {'label': 'Silmag', 'description': '20 patients managed by "Silmag" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.', 'interventionNames': ['Other: Tube assessment visits']}, {'label': 'Freka', 'description': '20 patients carrying "Freka" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.', 'interventionNames': ['Other: Tube assessment visits']}, {'label': 'Bard', 'description': '20 patients using the "Bard" gastrostomy tube. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.', 'interventionNames': ['Other: Tube assessment visits']}], 'interventions': [{'name': 'Tube assessment visits', 'type': 'OTHER', 'description': 'Patients will return every 2 months for clinical questionnaire about leaks, obstructions or other dysfunctions of the tube. Objective tube examination for cracks, rupture, obstruction or dislodgement, along with replacement if necessary, will be carried out (total of 3 visits/6 months)', 'armGroupLabels': ['Bard', 'Cook', 'Freka', 'Kangaroo', 'Silmag']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Joel Faintuch, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital das Clinicas, Sao Paulo, Brazil'}, {'name': 'Paulo Sakai, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital das Clinicas, Sao Paulo, Brazil'}, {'name': 'Emanuele L Villela, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital das Clinicas, Sao Paulo, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Gastroenterology', 'investigatorFullName': 'Joel Faintuch', 'investigatorAffiliation': 'University of Sao Paulo'}}}}