NCT06896864

Brief Summary

Evaluating the effectiveness and outcomes of cochlear implants in individuals with hearing loss,identifying common complications or risks associated with cochlear implantation, including device failure, surgical complications, or issues related to the patient's anatomy

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Apr 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Apr 2025May 2026

First Submitted

Initial submission to the registry

March 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

April 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

March 20, 2025

Last Update Submit

March 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-Surgical Complication Rate: Infection, device failure,Measures auditory progression

    Baseline

Interventions

After the surgery, patients typically undergo a period of recovery and healing. several factors including age at implantation, pre- and post-operative therapy, and parental involvement

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All cases implanted between 2014-2024 Patients who regularly use their cochlear implant device as recommended.

You may qualify if:

  • Patients with severe to profound bilateral sensorineural hearing loss who were candidates for CI.
  • Patients who regularly use their cochlear implant device as recommended.

You may not qualify if:

  • Non-Sensorineural Hearing Loss - Non-Functional Auditory Nerve - . Severe Mental or Cognitive Impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cochlear Implantation

Intervention Hierarchy (Ancestors)

Otologic Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativeProsthesis Implantation

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cochlear implantation in Assiut university hospital experience

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 26, 2025

Study Start

April 8, 2025

Primary Completion

March 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

March 26, 2025

Record last verified: 2025-03