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