Last reviewed · How we verify
NCT03261726
Maintaining Cochlear Patency After VIIIth Nerve Surgery
NA trial testing MedEl Test Electrode Placer in Acoustic Neuroma. Withdrawn.
4 March 2021
Quick facts
| Lead sponsor | Henry Ford Health System |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 4 August 2017 |
| Primary completion | 4 March 2021 |
| Estimated completion | 4 March 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- MedEl Test Electrode Placer
Conditions studied
- Acoustic Neuroma — all drugs for Acoustic Neuroma →
- Labyrinthitis Ossificans — all drugs for Labyrinthitis Ossificans →
- Profound Hearing Impairment — all drugs for Profound Hearing Impairment →
Sponsor
Henry Ford Health System — full company profile →
Who can join
Eligibility, any sex, with Acoustic Neuroma or Labyrinthitis Ossificans. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with progressive unilateral hearing loss and tinnitus. VIIIth Nerve tumors with documented growth on serial MRI scans typically lead to deafness in the affected ear over time. Radiation (Gamma Knife® or stereotactic radiosurgery) may preserve hearing in \~80% while surgery (middle cranial fossa or retrosigmoid approach) may preserve hearing in 16 - 40% of small tumors, although initial hearing preservation by both modalities may fail over time. Surgical resection via the translabyrinthine approach is the safest way to remove many of these tumors, but involves loss of all hearing. In all treatment modalities, the vascular supply (the labyrinthine artery, a terminal branch of AICA with no collaterals) to the cochlea is at risk. After devascularization, the cochlea frequently fills with fibrous tissue or ossifies (labyrinthitis ossificans), making it impossible to place a cochlear implant should it be required later. The incidence of this is 46% in our patients. This study seeks to determine the feasibility of preserving the cochlear duct with an obdurator so that patients undergoing translabyrinthine removal of VIIIth nerve tumors may retain the option of a cochlear implant at a later time.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03261726
- Europe PMC full search
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Related trials
Other recruiting trials for Acoustic Neuroma
Currently open trials in the same condition.
- NCT06112509 — Evolution of Vestibular Function After Treatment of a Vestibular Schwannoma by Gamma-knife Radio-surgery · NA · recruiting
Other Henry Ford Health System trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03261726 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Henry Ford Health System
- Last refreshed: 19 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03261726.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing