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NCT03795675 · ClinicalTrials.gov registry record · NA
CI Following VS Removal or Labyrinthectomy
A NA study of Vestibular Schwannoma and Meniere Disease, sponsored by Ohio State University.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03795675 is a NA study of Vestibular Schwannoma and Meniere Disease that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 15 participants, below the 50-participant average among 7 other Vestibular Schwannoma trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03795675, a NA study of Vestibular Schwannoma and Meniere Disease, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere's disease. Individuals undergoing these surgeries will be deaf on the surgical side after the procedure. Currently, cochlear implants are approved for use and not considered investigational in individuals with hearing loss on both sides. However, use of a cochlear implant for these patient populations (single-sided hearing loss) will be considered a new use of an approved device. Participants undergoing surgery to remove a VS or having a labyrinthectomy will have a cochlear implant inserted after the surgical procedure for clinical care. Approximately 4 weeks after surgery, participants will be fitted with an external speech processor on the surgical side that will stimulate the internal cochlear implant. Participants will return at the following intervals after the initial processor fitting: 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months. At each interval, participants will complete questionnaires on how they are hearing with the implant and their quality of life with the implant and be tested on their ability to hear sounds and understand speech. Potential risks are those associated with all cochlear implant surgeries, and include device failure resulting in removal of device, irritation or redness in surgical area and/or area where processor is attached, increased ringing in the ear, facial nerve stimulation and a change in the way speech and other sounds sound through the implant. Potential benefits to individual participants in this study include improvement in detection and speech understanding of the surgical ear. Participants may also experience improved abilities to locate sound and understand speech in noise as the result of having hearing on both sides.
Conditions Studied
Interventions
- DEVICE Cochlear Implant
Study Locations (1)
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-01-14 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03795675
The ClinicalTrials.gov registry entry for NCT03795675 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 50-participant average among 7 other Vestibular Schwannoma trials with a reported enrollment target (70% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Vestibular Schwannoma appearing as the primary indexed condition, and to 1 intervention - of which Cochlear Implant is the first listed.
NCT03795675 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03795675 about?
NCT03795675 is a clinical study titled "CI Following VS Removal or Labyrinthectomy". This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere's disease...
What is the current status of trial NCT03795675?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2019-01-14. Estimated completion is 2027-12-31.
What conditions does trial NCT03795675 study?
This clinical trial studies the following conditions: Vestibular Schwannoma, Meniere Disease.
What interventions are being tested in trial NCT03795675?
The interventions under investigation include: Cochlear Implant (DEVICE).
Who is sponsoring clinical trial NCT03795675?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03795675 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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