An interventional study of MedEl Test Electrode Placer in Acoustic Neuroma, Labyrinthitis Ossificans and Profound Hearing Impairment, sponsored by Henry Ford Health System. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Treatment
Among 39 studies in Neuroma, Acoustic with a site in United States — 8 open to participants now, 11 under way, none of them phase 3. Neuroma, Acoustic · United States.
Among the 39 studies in Neuroma, Acoustic with a site in United States, this one is the 31st largest by enrollment of the 34 interventional ones that give a count, is one of 2 that started in 2017, is one of 15 with no phase, and was the 22nd registered.
100 studies on the registry are indexed under Neuroma, Acoustic; 28 are open to participants now.
Browse Neuroma, Acoustic studies →8 of the 39 studies in Neuroma, Acoustic with a site in United States are open now. Recruiting first, the newest first:
Eben Rosenthal · Sites in United States
Ages 18+
Eli Lilly and Company · Sites in United States
Ages 18+
Medical College of Wisconsin · Sites in United States
Ages 18+
Johns Hopkins University · Sites in United States
Ages 21–70 · Healthy volunteers
Scott R. Plotkin, MD, PhD · Sites in United States
Ages 12+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 22 Neuroma, Acoustic studies recruiting now, 9 (41%) set no upper age limit and 8 (36%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: all sexes · healthy volunteers too.
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39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 13
First in 2000; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 15 across the 34 interventional studies, 100 across the 5 observational. Of the 21 that completed or were terminated, 11 (52%) have results posted.
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3 of 39 have an industry lead sponsor. The 10 most frequent:
Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.
Henry Ford Health System has 2 studies filed under Neuroma, Acoustic — fewer than ten, so there is no comparison to draw.
5 of the studies in Neuroma, Acoustic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01199978Massachusetts General HospitalHearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma | 2026-12 |
| NCT03795675Ohio State UniversityCI Following VS Removal or Labyrinthectomy | 2027-01-31 |
| NCT05622344Johns Hopkins UniversityStableEyes With Active Neurofeedback | 2027-03-30 |
| NCT03079999Massachusetts Eye and Ear InfirmaryStudy of Aspirin in Patients With Vestibular Schwannoma | 2027-03-31 |
| NCT05702749Medical College of WisconsinEvaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas | 2027-07 |
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Among the 39 studies in Neuroma, Acoustic with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
MedEl Test Electrode Placed at VIIIth nerve tumor resection
Device: MedEl Test Electrode Placer
This study uses a sterile dummy (i.e., not working) cochlear implant electrode inserted at the time of tumor removal to keep the inner ear from scarring or filling with bone. The significance of this to you is that if you ever become eligible for a cochlear implant sometime after surgery, it may be possible to remove the dummy and insert a functioning cochlear implant.
Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode
Office visits and MRI monitoring: 1. 2 - 3 weeks after surgery: Routine post-operative visit for wound care. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. 2. 3 - 4 months after surgery: Monitoring MRI with and without contrast of the inner ear/internal auditory canals with routine post-operative visit. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. III. Document appearance of the cochlea on heavily T2-weighted images. 3. Study Endpoint: 1 year after surgery. Repeat MRI with and without contrast of the inner ear/internal auditory canals. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. III. Document appearance of the cochlea on heavily T2-weighted images.
Time frame: One year postoperatively
Presence or absence of fluid in the cochlea
Appearance of the implanted cochlea on heavily T2-weighted monitoring MRI 3-4 months after surgery and 1 year after surgery.
Time frame: 3- 4 months and 1 year after tumor removal and implantation of the insertion electrode
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Mar 2021, 43 months.
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This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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