NCT04815655

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Status
unknown

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

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 23, 2021

Last Update Submit

March 23, 2021

Conditions

Cartilage Tympanoplasty

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Cartilage tympanoplastyPROCEDURE

is the reconstruction of the tympanic membrane (TM) by using catilage

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hamza Elshafie, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroleen Mounir, Resident

CONTACT

01206045590Caroleenmounir@gmail.com

Mostafa Osman, Professor

CONTACT

01005450751mostafaosmanramadan@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share