NCT02096809 - 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)

Dun CA, de Wolf MJ, Hol MK, Wigren S, Eeg-Olofsson M, Green K, Karlsmo A, Flynn MC, Stalfors J, Rothera M, Mylanus EA, Cremers CW
Stability, survival, and tolerability of a novel baha implant system: six-month data from a multicenter clinical investigation. Otol Neurotol. 2011 Aug;32(6):1001-7. doi: 10.1097/MAO.0b013e3182267e9c.
Faber HT, Dun CA, Nelissen RC, Mylanus EA, Cremers CW, Hol MK
Bone-anchored hearing implant loading at 3 weeks: stability and tolerability after 6 months. Otol Neurotol. 2013 Jan;34(1):104-10. doi: 10.1097/MAO.0b013e318277a282.
Holgers KM, Tjellström A, Bjursten LM, Erlandsson BE
Soft tissue reactions around percutaneous implants: a clinical study of soft tissue conditions around skin-penetrating titanium implants for bone-anchored hearing aids. Am J Otol. 1988 Jan;9(1):56-9.
Larsson A, Wigren S, Andersson M, Ekeroth G, Flynn M, Nannmark U
Histologic evaluation of soft tissue integration of experimental abutments for bone anchored hearing implants using surgery without soft tissue reduction. Otol Neurotol. 2012 Oct;33(8):1445-51. doi: 10.1097/MAO.0b013e318268d4e0.
McLarnon CM, Johnson I, Davison T, Hill J, Henderson B, Leese D, Marley S
Evidence for early loading of osseointegrated implants for bone conduction at 4 weeks. Otol Neurotol. 2012 Dec;33(9):1578-82. doi: 10.1097/MAO.0b013e31826dba5f.
Wazen JJ, Young DL, Farrugia MC, Chandrasekhar SS, Ghossaini SN, Borik J, Soneru C, Spitzer JB
Successes and complications of the Baha system. Otol Neurotol. 2008 Dec;29(8):1115-9. doi: 10.1097/MAO.0b013e318187e186.

Evaluation of Soft Tissue Healing and Implant Stability of Cochlear Baha BI300/BA400 Implant System Loaded From 1 Week Post-surgery After Linear Incision Without Soft Tissue Reduction.

Details for clinical trial NCT02096809

Clinical trial NCT02096809 - References