A Phase 2 interventional study of Cochlear Implantation and Cochlear Implantation+dexamethasone in Hearing Loss, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-10-03.
Sponsored by University of Sao Paulo General Hospital · Phase 2, Interventional, and Treatment
The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation
Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development of soft surgical techniques and pharmacological protection.
In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 18 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cochlear Implantation
Device: Cochlear Implantation
Cochlear implantation using topical dexamethasone
Device: Cochlear Implantation · Drug: Cochlear Implantation+dexamethasone
Cochlear implantation using topical dexamethasone associated with hyaluronic acid
Device: Cochlear Implantation · Drug: Cochlear Implantation+dexamethasone+hyaluronic acid
Cochlear implantation using Hybrid L24 Implant
Also known as: Hybrid L24 Implant
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window
Also known as: Hybrid L24 Implant, Dexamethasone (4mg/ml)
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array
Also known as: Hybrid L24 Implant, Dexamethasone (4mg/ml), Hyaluronic acid (10mg/ml)
Hearing thresholds
Hearing thresholds will be measured by audiometry in the frequencies 125, 250, 500, 1000, 2000 and 4000 Hz in the preoperatory, 1 month, 3 months and 6 months after the surgery.
Time frame: within the first 6 months after surgery
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital