NCT05072678

Brief Summary

to compare, the osseous density in the mastoid of two products used to obliterate the mastoid during surgery for cholesteatoma

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 25, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2023

Completed
Last Updated

October 11, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 29, 2021

Last Update Submit

September 28, 2021

Conditions

Prospective Study

Keywords

osteoingrationsurgerycholesteatome

Outcome Measures

Primary Outcomes (1)

  • Hounsfield Unit

    The attenuation and osseointegration of the BG granules: The quantitative analysis included bone attenuation measurements (in Hounsfield units, HU) in the circular region of interest (34mm2) of BGand of surrounding cortical bone and otic capsule using the otic capsule adjacent to the LSCC and the posterior fossa dural plate (DP)

    one year

Secondary Outcomes (2)

  • decibel

    one year

  • decibel

    one year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with cholesteatoma surgery

You may qualify if:

  • Adult with cholesteatoma surgery Accepting the protocol and the radiological follow-up

You may not qualify if:

  • patient less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU De Brest

Brest, 29200, France

RECRUITING

Central Study Contacts

remi Marianowski, MD, PhD

CONTACT

33298223333remi.marianowski@chu-brest.fr

sonia Sahli Vivi Corsi, MD

CONTACT

33298223052soni.sahli@chu-brest.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

October 11, 2021

Study Start

April 25, 2021

Primary Completion

April 25, 2022

Study Completion

April 25, 2023

Last Updated

October 11, 2021

Record last verified: 2021-04

Locations

FR(1)