Cartilage Tympanoplasty for Recurrent Perforation Full Th... | NCT04815655

Studies
Cartilage Tympanoplasty for Recurrent Perforation Full Thickness Versus Partial Thickness Graft

NCT04815655

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 25, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Cartilage Tympanoplasty

Interventions

Cartilage tympanoplasty

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Estimated

Primary Completion Date

Apr 1, 2022Estimated

Completion Date

Apr 1, 2022Estimated

First Submitted Date

Mar 23, 2021

First Submission Date that Met QC Criteria

Mar 23, 2021

First Posted Date

Mar 25, 2021Actual

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 23, 2021

Last Update Posted Date

Mar 25, 2021Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cartilage tympanoplasty for recurrent perforation full thickness versus partial thickness graft.

Detailed Description

To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cartilage tympanoplasty	Procedure	is the reconstruction of the tympanic membrane (TM) by using catilage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer	To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1 -patients with safe chronic suppurative otitis media 2- patients with recurrent perforations 3- patients with conductive hearing loss- 4- patients above 18 years

Exclusion Criteria:

active infection
sensorineural hearing loss
compromised immune system 4 - patients age below 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Caroleen Mounir, Resident	Contact	01206045590		Caroleenmounir@gmail.com
Mostafa Osman, Professor	Contact	01005450751		mostafaosmanramadan@aun.edu.eg

Overall Officials

Name	Affiliation	Role
Hamza Elshafie, Professor	Assiut University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided