Trials / Unknown
UnknownNCT05079867
Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery
Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery: Comparative Study Between Perimodiolar and Lateral Wall Electrodes
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- Hospital Italiano de Buenos Aires · Academic / Other
- Sex
- All
- Age
- 12 Months
- Healthy volunteers
- Not accepted
Summary
Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.
Detailed description
Branches: * Perimodiolar (PM) * Lateral wall (PL) Follow up schedule: Preoperative visit POV1 (up to 90 days before D0) Intraoperative visit D0 (Surgery - Day 0) Follow-up visit 1 FUV1 (48 hours) Follow-up visit 2 FUV2 14 days Follow-up visit 3 FUV3 (4 weeks) Follow-up visit 4 FUV4 (3 months) Follow-up visit 5 FUV5 (6 months) Follow-up visit 6 FUV6 (12 months)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cochlear implantation | Electrode surgically implanted in patient's cochlea to improve hearing |
Timeline
- Start date
- 2021-07-19
- Primary completion
- 2022-12-19
- Completion
- 2023-12-19
- First posted
- 2021-10-15
- Last updated
- 2021-10-15
Locations
1 site across 1 country: Argentina
Source: ClinicalTrials.gov record NCT05079867. Inclusion in this directory is not an endorsement.