protocolSection identificationModule nctId: NCT06335394, orgStudyIdInfo id: NVD003-CLN01, briefTitle: Prospective Study in Adults Evaluating Safety & Efficacy of NVD003 for Bone Reconstruction to Treat Lower Limb Nonunion, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-08-02, primaryCompletionDateStruct date: 2022-04-27, completionDateStruct date: 2028-05-15, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Novadip Biosciences, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of recalcitrant lower limb nonunion., conditionsModule conditions: Recalcitrant Lower Limb Nonunion, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 11, type: ACTUAL, armsInterventionsModule interventions name: NVD003, outcomesModule primaryOutcomes measure: Safety - Adverse Events, primaryOutcomes measure: Safety - Abnormalities of vital signs, primaryOutcomes measure: Safety - Abnormalities of vital signs, primaryOutcomes measure: Safety - Abnormalities of physical examination, primaryOutcomes measure: Safety - Abnormalities of physical examination, primaryOutcomes measure: Safety - Abnormalities of physical examination, primaryOutcomes measure: Safety - Abnormalities of laboratories, primaryOutcomes measure: Safety - Abnormalities of laboratories, primaryOutcomes measure: Safety - Abnormalities of laboratories, secondaryOutcomes measure: Healing efficacy: plain X-ray, secondaryOutcomes measure: Healing efficacy: CT-scan, secondaryOutcomes measure: Healing efficacy: average time from Investigational Medicinal Product grafting surgery till first observation of plain X-ray and CT-scan confirmed fracture healing, secondaryOutcomes measure: Healing efficacy: investigator assessed clinical healing, secondaryOutcomes measure: Healing efficacy: average time from IMP grafting surgery to Investigator assessed clinical healing, secondaryOutcomes measure: Grafting Surgery parameters, secondaryOutcomes measure: Grafting Surgery parameters, secondaryOutcomes measure: Complications: rate of subsequent surgical interventions, secondaryOutcomes measure: Quality of Life: pain evaluation, secondaryOutcomes measure: Quality of Life: questionnaire EuroQol-5 Dimensions, secondaryOutcomes measure: Quality of Life: overall treatment effect, secondaryOutcomes measure: General Pre-graft implantation safety: all SAEs, AESI and PRAE, secondaryOutcomes measure: All SAEs during the extended safety follow-up period, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier Interregional Edith Cavel (CHIREC) - Clinique Ste Anne-St Remi, city: Anderlecht, zip: 1070, country: Belgium, geoPoint lat: 50.83619, lon: 4.31454, locations facility: Algemeen Ziekenhuis (AZ) Sint-Jan Brugge - Oostende AV - Campus Sint-Jan, city: Brugge, zip: 8000, country: Belgium, geoPoint lat: 51.20892, lon: 3.22424, locations facility: Centre Hospitalier Universitaire CHU/UVC Brugmann (Site Horta), city: Brussel, zip: 1020, country: Belgium, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Grand Hôpital De Charleroi, city: Charleroi, country: Belgium, geoPoint lat: 50.41136, lon: 4.44448, locations facility: Ziekenhuis Oost-Limburg (ZOL), city: Genk, zip: 3600, country: Belgium, geoPoint lat: 50.965, lon: 5.50082, locations facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg, city: Leuven, zip: 3000, country: Belgium, geoPoint lat: 50.87959, lon: 4.70093, locations facility: CHU Ambroise Paré, city: Mons, zip: 7000, country: Belgium, geoPoint lat: 50.45413, lon: 3.95229, locations facility: Centre Hospitalier Regional De Namur, city: Namur, zip: 5000, country: Belgium, geoPoint lat: 50.4669, lon: 4.86746, locations facility: Centre Hospitalier de Luxembourg, city: Luxembourg, zip: 1210, country: Luxembourg, geoPoint lat: 49.61167, lon: 6.13, locations facility: University Hospital Basel, city: Basel, country: Switzerland, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False