Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-28 @ 2:13 PM
Study NCT ID:
NCT00971269
Status:
UNKNOWN
Last Update Posted:
2009-09-03
First Post:
2009-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of NASHA/Dx Gel for Fecal 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-02', 'studyFirstSubmitDate': '2009-09-02', 'studyFirstSubmitQcDate': '2009-09-02', 'lastUpdatePostDateStruct': {'date': '2009-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fecal incontinence episodes', 'timeFrame': 'Follow up during a four week period and after 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Side effects related to treatment', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fecal Incontinence']}, 'descriptionModule': {'briefSummary': 'The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Fecal incontinence with at least 2 episodes/week\n2. Symptom duration at least one year\n3. Failed attempt of conservative therapy\n4. Age 18-80\n5. Written informed consent\n6. Available for follow-up\n7. Fully compliant with protocol\n\nExclusion Criteria:\n\n1. Active inflammatory bowel disease\n2. Total external sphincter defect at ultrasound and clinical examination\n3. Bleeding diathesis or anticoagulant therapy\n4. Rectal prolapse or intussusceptions\n5. Present anal sepsis\n6. Anorectal implants\n7. Recent anorectal surgery (within 6 months)\n8. Rectal anastomosis\n9. Pregnancy, postpartum (one year) or breast feeding'}, 'identificationModule': {'nctId': 'NCT00971269', 'briefTitle': 'Pilot Study of NASHA/Dx Gel for Fecal Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University Hospital'}, 'officialTitle': 'A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence', 'orgStudyIdInfo': {'id': 'EPN 2008/066'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Solesta (Nasha/Dx)', 'type': 'DEVICE', 'otherNames': ['Solesta'], 'description': 'Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks'}]}, 'contactsLocationsModule': {'locations': [{'city': '751 82 Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Wilhelm JR Graf, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Surgery, University Hospital'}], 'centralContacts': [{'name': 'Wilhelm JR Graf, MD PhD', 'role': 'CONTACT', 'email': 'wilhelm.graf@akademiska.se', 'phone': '+46(0)18 611 46 06'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Wilhelm Graf', 'oldOrganization': 'Dept of Surgery, Uppsala University Hospital'}}}}