Thoracic Computed Tomography Scan for Diagnosis of Aspira... | NCT00747981

Studies
Thoracic Computed Tomography Scan for Diagnosis of Aspirated Foreign Bodies.

NCT00747981

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jan 15, 2026Actual

Enrollment

311Actual

Phase

Not Applicable

Conditions

Aspirated Foreign Body of Lower Respiratory Tract

Interventions

Thoracic CT Scan

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Apr 2010Actual

Completion Date

Oct 2011Actual

First Submitted Date

Sep 5, 2008

First Submission Date that Met QC Criteria

Sep 5, 2008

First Posted Date

Sep 8, 2008Estimated

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

Jan 14, 2026

Last Update Posted Date

Jan 15, 2026Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 access CT Scan as a diagnostic tool for foreign bodies aspiration.

Detailed Description

Comparison with gold standard diagnostic tool, the endoscopy

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

311Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Thoracic CT Scan	Procedure: Thoracic CT Scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thoracic CT Scan	Procedure	Perform a CT Scan and an endoscopy	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison between CT Scan and endoscopy results		12 HOURS

Secondary Outcomes

Measure	Description	Time Frame
X Ray radiation induced by CT Scan		TWO YEARS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 6 months and 16 years
suspicion of a foreign body aspiration
health care assurance
information of parents

Exclusion Criteria:

emergency situation
certainly of foreign body presence
delay for CT Scan realization longer than 24 hours
no speaking French parents
parents refusal.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yves MANACH, MD, HDR	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Paris V University & Assistance Publique Hôpitaux de Paris		Paris		75015	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23489882	Result	Manach Y, Pierrot S, Couloigner V, Ayari-Khalfallah S, Nicollas R, Venail F, Pondaven S, Baculard F, Tantcheu V. Diagnostic performance of multidetector computed tomography for foreign body aspiration in children. Int J Pediatr Otorhinolaryngol. 2013 May;77(5):808-12. doi: 10.1016/j.ijporl.2013.02.016. Epub 2013 Mar 13.