Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
102 participants
INTERVENTIONAL
2024-05-15
2026-12-31
Brief Summary
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Detailed Description
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The PRESERVE trial is an international, multi-centre, randomised controlled trial. The trial will randomly allocate adult cochlear implant recipients to undergo implantation surgery either with ECochG-guidance, or via the standard approach without guidance. Participants will be blinded, meaning they will not know which group they will be allocated to. Where ECochG is used, evidence of damage during insertion detected with the monitoring will trigger the surgeon to follow a corrective pathway. All other aspects of surgery and post operative care will follow standard clinical pathways for both groups.
Participants will have their natural hearing measured preoperatively, and 3- and 6-months following implant activation. The change in natural hearing thresholds at different frequencies, and the degree of hearing preservation will then be calculated and compared between the standard surgery and ECochG-guided group. Using their cochlear implant, understanding of speech will also be measured and compared between groups. In addition, participants will undergo a second CT scan following implantation surgery, and this will be compared to the routine pre-operative imaging to assess both the location of the implant electrode, and structural preservation of the cochlear. Throughout the study participants will remain under the care of their routine medical team.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
ECochG monitored CI surgery incl. corrective action guide
ECochG monitored CI surgery incl. corrective action guide
Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide
Control
Routine CI surgery without ECochG monitoring
Routine CI surgery without ECochG monitoring
Routine CI surgery with access to ECochG monitoring by surgeon
Interventions
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ECochG monitored CI surgery incl. corrective action guide
Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide
Routine CI surgery without ECochG monitoring
Routine CI surgery with access to ECochG monitoring by surgeon
Eligibility Criteria
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Inclusion Criteria
* Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted
* Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted
* Less than 15 years of severe to profound deafness on the implant ear prior to surgery
* Post-lingually acquired hearing loss in the ear to be implanted
* Normal cochlear anatomy as confirmed by pre-operative imaging in the ear to be implanted
* Listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array
* Listed for cochlear implant surgery under general anaesthesia
* Fluent in local language
* Given informed consent to participate in the study
Exclusion Criteria
* Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted
* Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections
* Diagnosis of auditory spectrum neuropathy disorder
* Deafness due to lesions of the acoustic nerve or central auditory pathway
* Deafened by meningitis
* Single sided deafness (average for 500, 1000, 2000 and 4000 Hz in the better ear ≤ 30 dB HL)
* Asymmetric hearing loss (average for 500, 1000, 2000 and 4000 Hz in the better ear \> 30 dB HL and ≤ 55 dB HL)
* History of previous cochlear implantation/re-implantation on either ear
* Any contraindications to computed tomography (CT) scans
* Concurrent participation in other cochlear implant related studies
18 Years
ALL
No
Sponsors
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Advanced Bionics AG
INDUSTRY
Responsible Party
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Principal Investigators
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Matt E Smith, Dr
Role: PRINCIPAL_INVESTIGATOR
Cambridge University Hospitals NHS Foundation Trust
Locations
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Universitair Ziekenhuis Gent
Ghent, Gent, Belgium
Le Centre Hospitalier Régional Universitaire de Tours
Tours, Tours, France
Universitätsklinikum Freiburg Klinik
Freiburg im Breisgau, Freiburg, Germany
Ospedale Martini
Torino, TO, Italy
World Hearing Center
Warsaw, Nadarzyn, Poland
Hospital Universitario Clinico San Cecilio
Granada, Granada, Spain
Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Countries
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Central Contacts
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References
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Bester C, Collins A, Razmovski T, Weder S, Briggs RJ, Wei B, Zakaria AF, Gerard JM, Mitchell-Innes A, Tykocinski M, Kennedy R, Iseli C, Dahm M, Ellul S, O'Leary S. Electrocochleography triggered intervention successfully preserves residual hearing during cochlear implantation: Results of a randomised clinical trial. Hear Res. 2022 Dec;426:108353. doi: 10.1016/j.heares.2021.108353. Epub 2021 Sep 20.
Buechner A, Bardt M, Haumann S, Geissler G, Salcher R, Lenarz T. Clinical experiences with intraoperative electrocochleography in cochlear implant recipients and its potential to reduce insertion trauma and improve postoperative hearing preservation. PLoS One. 2022 Apr 22;17(4):e0266077. doi: 10.1371/journal.pone.0266077. eCollection 2022.
Carlson ML, Driscoll CL, Gifford RH, Service GJ, Tombers NM, Hughes-Borst BJ, Neff BA, Beatty CW. Implications of minimizing trauma during conventional cochlear implantation. Otol Neurotol. 2011 Aug;32(6):962-8. doi: 10.1097/MAO.0b013e3182204526.
Dalbert A, Sim JH, Gerig R, Pfiffner F, Roosli C, Huber A. Correlation of Electrophysiological Properties and Hearing Preservation in Cochlear Implant Patients. Otol Neurotol. 2015 Aug;36(7):1172-80. doi: 10.1097/MAO.0000000000000768.
Moore FL, Miller LJ. Stress-induced inhibition of sexual behavior: corticosterone inhibits courtship behaviors of a male amphibian (Taricha granulosa). Horm Behav. 1984 Dec;18(4):400-10. doi: 10.1016/0018-506x(84)90026-6.
Blackford HN, Murray K, Stephenson TP, Mundy AR. Results of transvesical infiltration of the pelvic plexuses with phenol in 116 patients. Br J Urol. 1984 Dec;56(6):647-9. doi: 10.1111/j.1464-410x.1984.tb06137.x.
Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163.
Lenarz T, Timm ME, Salcher R, Buchner A. Individual Hearing Preservation Cochlear Implantation Using the Concept of Partial Insertion. Otol Neurotol. 2019 Mar;40(3):e326-e335. doi: 10.1097/MAO.0000000000002127.
O'Leary S, Mylanus E, Venail F, Lenarz T, Birman C, Di Lella F, Roland JT Jr, Gantz B, Beynon A, Sicard M, Buechner A, Lai WK, Boccio C, Choudhury B, Tejani VD, Plant K, English R, Arts R, Bester C. Monitoring Cochlear Health With Intracochlear Electrocochleography During Cochlear Implantation: Findings From an International Clinical Investigation. Ear Hear. 2023 Mar-Apr 01;44(2):358-370. doi: 10.1097/AUD.0000000000001288. Epub 2022 Nov 8.
Saoji AA, Patel NS, Carlson ML, Neff BA, Koka K, Tarigoppula VSA, Driscoll CLW. Multi-frequency Electrocochleography Measurements can be Used to Monitor and Optimize Electrode Placement During Cochlear Implant Surgery. Otol Neurotol. 2019 Dec;40(10):1287-1291. doi: 10.1097/MAO.0000000000002406.
Brown DC, Conzemius MG, Shofer F, Swann H. Epidemiologic evaluation of postoperative wound infections in dogs and cats. J Am Vet Med Assoc. 1997 May 1;210(9):1302-6.
Verberne J, Risi F, Campbell L, Chambers S, O'Leary S. The Effect of Scala Tympani Morphology on Basilar Membrane Contact With a Straight Electrode Array: A Human Temporal Bone Study. Otol Neurotol. 2017 Jan;38(1):47-53. doi: 10.1097/MAO.0000000000001259.
Related Links
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Cochlear implants for children and adults with severe to profound deafness - Technology appraisal guidance \[TA566\]
Other Identifiers
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ABIntl-23-25
Identifier Type: -
Identifier Source: org_study_id
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