Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT04982120
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2021-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Repris Needle in Bladder Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-07-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure Success', 'timeFrame': '1 Day of the procedure', 'description': 'Percentage of subjects with successful injection of medication'}], 'secondaryOutcomes': [{'measure': 'Patient Tolerance of Injection', 'timeFrame': '1 Day of the procedure', 'description': 'Level of pain from use of the needle measured on Likert Scale 1 to 5'}, {'measure': 'Adverse Events during Procedure', 'timeFrame': 'Day 0 and Day 5', 'description': 'Incidence and Severity of Adverse events associated with the injection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Overactive Bladder Syndrome']}, 'descriptionModule': {'briefSummary': 'Treatment of overactive bladder (OAB) has been treated successfully by the injection of Botox. The Repris injection needle has a deflection that may assist in injection difficult to reach with standard straight needles. This study will assess the success, safety and patient tolerance of this new injection needle.', 'detailedDescription': "This is a prospective, multicenter, single arm study of the Repris injection needle to administer Botox to the bladder wall in patients with an overactive bladder. Following advancement of a cystoscope to the patient's bladder, the Repris needle will be advanced to the area of interest and into the bladder wall in order to administer the recommended volume of Botox. After injection, the needle will be removed and the procedure will be concluded. The patient will be asked to rank her tolerance of the procedure and level of discomfort using a standardized pain scale before being released. Five days after the procedure the patient will be contacted by telephone to determine whether any adverse events had occurred since release."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Overactive bladder syndrome is more frequently treated in females than males', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (18 years of age or older)\n* Able to undergo routine cystoscopy\n* Willing to provide verbal assessment of her condition within 5 days after the procedure\n\nExclusion Criteria:\n\n* History of urethral strictures\n* Presence of a suprapubic catheter or tube due to urethral trauma\n* history of interstitial cystitis\n* currently being treated for a urinary tract infection (UTI)\n* gross hematuria present\n* Known allergy or sensitivity to any component of the medication or solution to be injected during the study\n* is pregnant, lactating, or with child-bearing potential unable or unwilling to use a reliable form of contraception while participating in the study\n* cannot empty her bladder on her own and is routinely catheterizing the urethra\n* unable to read, understand, and/or provide a ranking of pain level during the procedure,\n* unable or unwilling to provide consent'}, 'identificationModule': {'nctId': 'NCT04982120', 'briefTitle': 'Use of Repris Needle in Bladder Injection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Uro-1 Medical'}, 'officialTitle': 'A Post-510(k) Study of Patients With Overactive Bladder (OAB) Treated With OnabotulinumtoxinA (Botox, Allergan PLC) Using the Repris Bladder Injection System', 'orgStudyIdInfo': {'id': 'Repris Botox Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Repris Needle', 'description': 'Reprise sheath and needle', 'interventionNames': ['Device: Repris Needle']}], 'interventions': [{'name': 'Repris Needle', 'type': 'DEVICE', 'description': 'Injection of Botox', 'armGroupLabels': ['Repris Needle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30120', 'city': 'Cartersville', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Proctor, MD', 'role': 'CONTACT', 'phone': '770-607-1893'}], 'facility': 'Georgia Urology', 'geoPoint': {'lat': 34.16533, 'lon': -84.80231}}], 'centralContacts': [{'name': 'Thomas Lawson, PhD', 'role': 'CONTACT', 'email': 'drthomlawson@gmail.com', 'phone': '5102061794'}, {'name': 'Jack Snoke', 'role': 'CONTACT', 'email': 'pjsnoke@uro1medical.com', 'phone': '3365750434'}], 'overallOfficials': [{'name': 'Thomas Lawson, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uro-1 Medical'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Within 7 days after completion of study', 'ipdSharing': 'YES', 'description': 'Patient identification will not be shared', 'accessCriteria': 'Permission from PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uro-1 Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}