NL-OMON40648
Completed
N/A
A Prospective, Multi-Center Study of the IlluminOss® Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pathological Fractures in the Humerus from Metastatic Bone Disease - PBSS - Pathological Humerus Fractures
IlluminOss Medical In.0 sites4 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- bone healing
- Sponsor
- IlluminOss Medical In.
- Enrollment
- 4
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •General inclusion criteria:
- •\- Skeletally mature adult males and females 18 years of age or older
- •\- Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease
- •\- Females: neither pregnant nor intending to become pregnant during the course of the study
- •\- Able to understand and provide informed consent
- •\- Willing and able to comply with post\-operative treatment protocol and follow\-up visit schedule;Impending Fracture\-Specific Inclusion Criteria:
- •\- Documented presence of solitary metastatic lesion.
- •\- Mirels Criteria Score \>\= 8\.
- •\- Destruction of cortical bone at impending fracture site \> 50%.;Actual Fracture\-Specific Inclusion Criteria:
- •\- Radiograph\-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A1, 11A2 and 11B1, 11B2 and 12A1,12A2 and 12B1, 12B2 and 13A1,13A2 and 13B1, 13B2\.
Exclusion Criteria
- •General Exclusion Criteria:
- •\- Primary tumor (osteogenic origin, etc.) at site
- •\- Impending fracture or actual fracture location other than humerus
- •\- Current concomitant traumatic fracture of any other location
- •\- Active or incompletely treated infections that could involve the device implant site
- •\- Distant foci of infection that may spread to the implant site
- •\- Allergy to implant materials or dental glue
- •\- Vascular insufficiency, muscular atrophy, or neuromuscular disease at implant site
- •\- Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder);Impending Fracture\-Specific Exclusion Criteria:
- •\- Mirels Score \< 8
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
N/A
A prospective, multi-centre study investigating the incidence and prognosis of relapses, pseudo-relapses and other causes of (sub)acute neurological symptoms in patients with relapsing-remitting multiple sclerosis.NL-OMON55562Sint Elisabeth Ziekenhuis125
Completed
N/A
A multicentre Prospective study in pAtients undergoing ventral herNia repair by open approach with intrA-peritoneal positioning using parietex* Composite vEntral pAtch.hernia / abdominal wall defect10041297NL-OMON40149Covidien8
Completed
Phase 4
A Prospective, Randomized, Multi-center Study to Assess the SaFety of the Orsiro Mission Stent compared to the ResoLute Onyx Stent in Subjects at High Risk for Bleeding in combination With 1-month Dual Antiplatelet Therapy (DAPT).NL-OMON52323BIOTRONIK AG1
Completed
Phase 4
A Multi Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after TransplantatioHeart and lung transplantation100192801003868610038716NL-OMON39373niversitair Medisch Centrum Utrecht30
Completed
N/A
Randomized, two-arm, multicenter study to evaluate the safety and efficacy of Dura Sealant Patch in reducing CSF leakage following elective cranial surgeryNL-OMON52748Polyganics BV, Groningen26