Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
Study NCT ID:
NCT01380132
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2011-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C487487', 'term': 'dextranomer-hyaluronic acid copolymer'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-27', 'studyFirstSubmitDate': '2011-06-21', 'studyFirstSubmitQcDate': '2011-06-23', 'lastUpdatePostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment response as measured by a 50% reduction in no of incontinence episodes.', 'timeFrame': 'One year posttreatment'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'One year posttreatment'}, {'measure': 'Global assessment', 'timeFrame': 'One year posttreatment', 'description': 'Graded by the patient as excellent, good, fair or poor'}, {'measure': 'Change in incontinence episodes', 'timeFrame': 'One year posttreatment', 'description': 'Measured relative baseline based on a 4-week diary'}, {'measure': 'Quality of life', 'timeFrame': 'One year posttreatment', 'description': 'Measured with a validated bowel function questionnaire'}, {'measure': 'Adverse events', 'timeFrame': 'Two years posttreatment'}, {'measure': 'Global assessment', 'timeFrame': 'Two years posttreatment', 'description': 'Graded by the patient as excellent, good, fair or poor'}, {'measure': 'Change in incontinence episodes', 'timeFrame': 'Two years posttreatment', 'description': 'Measured relative baseline based on a 4-week diary'}, {'measure': 'Quality of life', 'timeFrame': 'Two years posttreatment', 'description': 'Measured with a validated bowel function questionnaire'}, {'measure': 'Treatment response as measured by a 50% reduction in no of incontinence episodes.', 'timeFrame': 'Two years posttreatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fecal incontinence', 'Treatment', 'Surgery'], 'conditions': ['Fecal Incontinence']}, 'referencesModule': {'references': [{'pmid': '19581853', 'type': 'RESULT', 'citation': 'Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1101-6. doi: 10.1007/DCR.0b013e31819f5cbf.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.', 'detailedDescription': 'Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.'}, 'eligibilityModule': {'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).\n* Age 18-80\n* Available for follow-up for the duration of the study\n* Written informed consent.\n\nExclusion Criteria:\n\n* Sphincter defect visible on anal ultrasound.\n* Pregnancy.\n* Rectal prolapse or inflammatory bowel disease.\n* Recent (within 6 months) anal surgery except for haemorrhoids.\n* Anorectal sepsis.\n* Anticoagulant medication or bleeding diathesis.'}, 'identificationModule': {'nctId': 'NCT01380132', 'briefTitle': 'Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University Hospital'}, 'officialTitle': 'Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence', 'orgStudyIdInfo': {'id': 'Nasha Dx Pilot study'}, 'secondaryIdInfos': [{'id': '03 464', 'type': 'OTHER', 'domain': 'EPN Uppsala'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anal injection of Nasha Dx', 'interventionNames': ['Procedure: Anal injection of Nasha Dx']}], 'interventions': [{'name': 'Anal injection of Nasha Dx', 'type': 'PROCEDURE', 'otherNames': ['Solesta'], 'description': 'Submucous injection of Nasha Dx 5-10 mm above dentate line', 'armGroupLabels': ['Anal injection of Nasha Dx']}]}, 'contactsLocationsModule': {'locations': [{'city': '751 82 Uppsala', 'country': 'Sweden', 'facility': 'Department of Surgery, University Hospital'}], 'overallOfficials': [{'name': 'Wilhelm JR Graf, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inst of Surgical Sciences, Uppsala university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Galderma R&D', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Olof Nilsson', 'oldOrganization': 'Uppsala university'}}}}