Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT04051892
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2019-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study Evaluating the FixNip™ NRI Safety and Performance
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The sample size will be 10 female subjects undergoing reconstruction of the nipple, S/P breast reconstruction surgery as a result of breast cancer.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2019-08-08', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction Evaluation', 'timeFrame': '12 months', 'description': 'Rate of Patient satisfaction questionnaire'}], 'primaryOutcomes': [{'measure': 'Adverse event', 'timeFrame': '12 months', 'description': 'Frequency and severity of Adverse Event . All adverse events occurring during the study will be reported'}], 'secondaryOutcomes': [{'measure': 'Nipple Projection', 'timeFrame': '12 months', 'description': 'Nipple projection in millimeter (mm)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reconstruction of the Breast Nipple and Areola Complex']}, 'descriptionModule': {'briefSummary': 'A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.', 'detailedDescription': 'This is a Prospective, Open label, Single arm, Multicenter Study enrolling female patients with a history of breast cancer following breast conservation surgery or mastectomy with breast reconstruction, seeking reconstruction of the breast nipple and areola complex.\n\nThe study is designed to evaluate the long-term safety and performance of the FixNip NRI in patients undergoing nipple reconstruction procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women between the ages of 22-70 years.\n* Patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. Effective methods of contraception must be used throughout the study.\n* History of breast cancer post mastectomy with breast implant or partial mastectomy (lumpectomy) of the central segment of the breast seeking reconstruction of the nipple and/or areola complex.\n* At least 3 months post breast reconstruction surgery.\n* Baker scale grade I or II capsular contracture.\n* No evidence of any systemic or chronic disease that might influence wound healing and infection rate.\n* Event free post breast and/or nipple reconstruction procedure, i.e. no skin infections or related infections that mandated antibiotic therapy, no wound dehiscence or any other related medical complications.\n* Pinch test of intended nipple location on affected breast of at least 15 mm.\n* Patient is willing to postpone tattooing until the end of follow-up period.\n* Patient is willing and able to give their written informed consent.\n\nExclusion Criteria:\n\n* Active malignant disease.\n* Subject has a chronic disease or any medical status that, according to surgeon discretion, prohibits from inclusion in the study i.e. diabetes.\n* History of tendency to produce hypertrophic scars or keloids.\n* Current use of any medications that can interfere with wound healing, impair the immune system functionality, or impair blood clotting mechanisms.\n* Active infection within the last 30 days.\n* Pregnant or nursing women.\n* Connective tissue disease.\n* 'Lupus disease' defined as Systemic Lupus Erythematous or Discoid Lupus, or scleroderma defined as Progressive Systemic Sclerosis per history.\n* Chronically treated with steroids or steroid therapy in a 3month period before surgery.\n* Demonstrate psychological characteristics, which, in the opinion of the Investigator and/or consulting physician(s) are incompatible with the risks, involved with the surgical procedure, prosthesis and compliance with follow-up recommendations.\n* Past or current capsular contracture defined as Baker III or IV.\n* Participating in any other investigational study for either drug or device which can influence collection of valid data under this study."}, 'identificationModule': {'nctId': 'NCT04051892', 'briefTitle': 'Multicenter Study Evaluating the FixNip™ NRI Safety and Performance', 'organization': {'class': 'INDUSTRY', 'fullName': 'FixNip Ltd'}, 'officialTitle': 'A Prospective, Open Label, Single Arm, Multicenter Study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.', 'orgStudyIdInfo': {'id': 'CLN003_0100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implantation of FixNip™ NRI', 'description': 'Female Patients Seeking Reconstructive Surgery of the Nipple', 'interventionNames': ['Device: FixNip™ NRI']}], 'interventions': [{'name': 'FixNip™ NRI', 'type': 'DEVICE', 'description': 'The FixNip™ NRI is an implantable hypodermic, silicone implant specially designed for nipple areola definition', 'armGroupLabels': ['Implantation of FixNip™ NRI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Assuta Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Michael Scheflan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuta MC'}, {'name': 'Ariel Tessone, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sheba MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FixNip Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}