Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT03746834
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2018-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}, {'id': 'D000071056', 'term': 'Anorectal Malformations'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients are treated with injection of NASHA/Dx and act as their own Controls over time.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2018-05-02', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of incontinence episodes', 'timeFrame': 'The change in number of incontinence episodes before treatment is compared with data at 18 months after injection.', 'description': 'The number of incontinences episodes as measured over a two week interval The number of incontience episodes is measured with a bowel-movement-diary over a two week period.'}], 'secondaryOutcomes': [{'measure': 'Miller´s incontinence score', 'timeFrame': 'Before treatment compared with data at 18 months after treatment. Miller´s incontinence score is measured on a scale from 0 (meaning total fecal continence) to 18 (meaning total fecal incontinence).', 'description': 'Change of Miller´s incontinence score'}, {'measure': 'Quality of life, general', 'timeFrame': 'Before treatment compared with data at 18 months after treatment. SF-36 measures quality of life in 8 subscales. Each scaled from 0 to 100. Higher score is considered better. Two total scores of mental and physical QoL can be calculated.', 'description': 'Change in quality of Life as observed with SF-36'}, {'measure': 'Adverse events', 'timeFrame': 'Before treatment compared with data at 18 months after treatment', 'description': 'Control of any adverse events during the course of the study'}, {'measure': 'Quality of life, disease specific', 'timeFrame': 'Before treatment compared with data at 18 months after treatment. Measures 4 subscales, each measuring 1-4. Higher score implies better quality of life.', 'description': 'Change in quality of Life as observed with FIQL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fecal incontinence', 'Anorectal malformation'], 'conditions': ['Fecal Incontinence', 'Anorectal Malformation']}, 'referencesModule': {'references': [{'pmid': '23224913', 'type': 'RESULT', 'citation': 'Danielson J, Karlbom U, Wester T, Graf W. Efficacy and quality of life 2 years after treatment for faecal incontinence with injectable bulking agents. Tech Coloproctol. 2013 Aug;17(4):389-95. doi: 10.1007/s10151-012-0949-8. Epub 2012 Dec 7.'}, {'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.'}, {'pmid': '27894765', 'type': 'RESULT', 'citation': 'Danielson J, Karlbom U, Graf W, Wester T. Outcome in adults with anorectal malformations in relation to modern classification - Which patients do we need to follow beyond childhood? J Pediatr Surg. 2017 Mar;52(3):463-468. doi: 10.1016/j.jpedsurg.2016.10.051. Epub 2016 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'Persistent fecal incontinence (FI) after anorectal malformations (ARM) is a common occurence. During the last two decades perianal injection therapy has emerged as an option for treating patients with FI due to other causes than ARMs. The studies done on different implants have always expempted patients with ARM which has led to ARM being a formal contraindication for treatment with perianal injection therapy.\n\nThe study aims to treat patients with persistent FI after ARM with perianal injection of NASHA/Dx (Solesta®) and follow them with Clinical examination and questionnaires up to 18 months post treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent FI (Miller incontinence score \\>5)\n* Anorectal malformation.\n\nExclusion Criteria:\n\n* Pregnancy\n* Rectal prolapse\n* Significant mucosal prolapse\n* Inflammatory bowel disease\n* Anorectal surgery within the last year Before inclusion\n* Anticoagulant medication/bleeding diathesis\n* Anorectal sepsis in the past\n* Immunodeficiency\n* Immunosuppressing therapy'}, 'identificationModule': {'nctId': 'NCT03746834', 'briefTitle': 'NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation', 'orgStudyIdInfo': {'id': '461:2013/6500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Patients are given NASHA/Dx as a perianal injection', 'interventionNames': ['Device: NASHA/Dx (Solesta®)']}], 'interventions': [{'name': 'NASHA/Dx (Solesta®)', 'type': 'DEVICE', 'description': 'Perianal submucosal injection of 3-4 ml of NASHA/Dx', 'armGroupLabels': ['Treatment arm']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data collected is of very personal type and since the number of subjects is so small there would be a risk of identification if all the data was released.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Johan Danielson', 'investigatorAffiliation': 'Uppsala University'}}}}