Cochlear Implantation Experience | NCT06896864

Studies
Cochlear Implantation Experience

NCT06896864

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Mar 26, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Cochlear Function Disorder

Interventions

cochlear implantation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 8, 2025Estimated

Primary Completion Date

Mar 30, 2026Estimated

Completion Date

May 30, 2026Estimated

First Submitted Date

Mar 20, 2025

First Submission Date that Met QC Criteria

Mar 20, 2025

First Posted Date

Mar 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2025

Last Update Posted Date

Mar 26, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tasneem Sayed Hussein, cochlear implantation in Assiut university hospital experience, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cochlear implantation	Procedure	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-Surgical Complication Rate: Infection, device failure,Measures auditory progression		Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with severe to profound bilateral sensorineural hearing loss who were candidates for CI.

Patients who regularly use their cochlear implant device as recommended.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D019929	Cochlear Implantation

Ancestor Terms

ID	Term
D013506	Otologic Surgical Procedures
D013517	Otorhinolaryngologic Surgical Procedures
D013514	Surgical Procedures, Operative
D019919	Prosthesis Implantation

Browse Leaves

Not provided

Browse Branches

Not provided