NCT02828306 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Chim H, Gosain AK
Biomaterials in craniofacial surgery: experimental studies and clinical application. J Craniofac Surg. 2009 Jan;20(1):29-33. doi: 10.1097/SCS.0b013e318190dd9e.
Della Puppa A, Rustemi O, Gioffrè G, Troncon I, Lombardi G, Rolma G, Sergi M, Munari M, Cecchin D, Gardiman MP, Scienza R
Predictive value of intraoperative 5-aminolevulinic acid-induced fluorescence for detecting bone invasion in meningioma surgery. J Neurosurg. 2014 Apr;120(4):840-5. doi: 10.3171/2013.12.JNS131642. Epub 2014 Jan 10.
Lassen B, Helseth E, Rønning P, Scheie D, Johannesen TB, Mæhlen J, Langmoen IA, Meling TR
Surgical mortality at 30 days and complications leading to recraniotomy in 2630 consecutive craniotomies for intracranial tumors. Neurosurgery. 2011 May;68(5):1259-68; discussion 1268-9. doi: 10.1227/NEU.0b013e31820c0441.
Stieglitz LH, Fung C, Murek M, Fichtner J, Raabe A, Beck J
What happens to the bone flap? Long-term outcome after reimplantation of cryoconserved bone flaps in a consecutive series of 92 patients. Acta Neurochir (Wien). 2015 Feb;157(2):275-80. doi: 10.1007/s00701-014-2310-7. Epub 2014 Dec 24.
Stieglitz LH, Gerber N, Schmid T, Mordasini P, Fichtner J, Fung C, Murek M, Weber S, Raabe A, Beck J
Intraoperative fabrication of patient-specific moulded implants for skull reconstruction: single-centre experience of 28 cases. Acta Neurochir (Wien). 2014 Apr;156(4):793-803. doi: 10.1007/s00701-013-1977-5. Epub 2014 Jan 18.

Computer Based Algorithm for Patient Specific Implants for Cranioplasty in Patients With Skull Defects: a Prospective Clinical Trial

Clinical trial NCT02828306 - References