NCT00747981

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
311

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

September 5, 2008

Last Update Submit

January 14, 2026

Conditions

Aspirated Foreign Body of Lower Respiratory Tract

Keywords

CT ScanEndoscopyAspirationForeign Bodies

Outcome Measures

Primary Outcomes (1)

  • Comparison between CT Scan and endoscopy results

    12 HOURS

Secondary Outcomes (1)

  • X Ray radiation induced by CT Scan

    TWO YEARS

Study Arms (1)

A

EXPERIMENTAL

Thoracic CT Scan

Procedure: Thoracic CT Scan

Interventions

Thoracic CT ScanPROCEDURE

Perform a CT Scan and an endoscopy

A

Eligibility Criteria

Age6 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paris V University & Assistance Publique Hôpitaux de Paris

Paris, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 23489882RESULT

MeSH Terms

Conditions

Foreign Bodies

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Yves MANACH, MD, HDR

    Assistance Publique Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 8, 2008

Study Start

May 1, 2008

Primary Completion

April 1, 2010

Study Completion

October 1, 2011

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

FR(1)