Clinical and Radiological Evaluation of Two Mastoid Filli... | NCT05072678

Studies
Clinical and Radiological Evaluation of Two Mastoid Filling Products

NCT05072678

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Oct 11, 2021Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Prospective Study

Interventions

Not provided

Countries

France

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2021Actual

Primary Completion Date

Apr 25, 2022Estimated

Completion Date

Apr 25, 2023Estimated

First Submitted Date

Apr 29, 2021

First Submission Date that Met QC Criteria

Sep 28, 2021

First Posted Date

Oct 11, 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

Sep 28, 2021

Last Update Posted Date

Oct 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

Detailed Description

Primary objective: To compare the radiological aspect in the petrous bone of two obliteration products in adults, one year after surgery (Bioactive Glass S53P4 and biological Hydroxy apatite) secondary objective : To evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 and biological hydroxy apatite when used in the mastoid and epitympanic obliteration for chronic otitis surgery

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
decibel	Auditory level pre and postoperative evaluation clinical	one year
decibel	audiological evaluation	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

patient less than 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients with cholesteatoma surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
remi Marianowski, MD, PhD	Contact	33298223333	CHU Brest	remi.marianowski@chu-brest.fr
sonia Sahli Vivi Corsi, MD	Contact	33298223052		soni.sahli@chu-brest.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU De Brest	Recruiting	Brest		29200	France