Foreign Body Removal With the Assistance of Ultrasound Gu... | NCT05085509

Studies
Foreign Body Removal With the Assistance of Ultrasound Guidance and Methylene Blue Staining in Children

NCT05085509

Sponsor

Yuxi Su

Status

Completed

Last Update Posted

Oct 20, 2021Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Foreign Bodies
Ultrasound

Interventions

US guidance and MB staining

Countries

China

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

Oct 2021

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 1, 2016Actual

Primary Completion Date

May 1, 2016Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Oct 6, 2021

First Submission Date that Met QC Criteria

Oct 19, 2021

First Posted Date

Oct 20, 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

Oct 19, 2021

Last Update Posted Date

Oct 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Soft-tissue foreign bodies (FB) are very commonly observed in pediatric emergency departments. Some are metallic and can be diagnosed easily via X-ray radiography, whereas others are radiolucent and are hence less easily diagnosed. Not all FB can be removed effectively, even via open surgery and C-arm guidance. This deficiency may potentially be addressed through the ultrasound (US) skills instrument, which is increasingly popular and is convenient for use in the operation room. In the current study, we evaluated the efficiency of FB removal with the assistance of US and methylene blue (MB) staining.

Detailed Description

Not provided

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound	Experimental	Ultrasound guidance and methylene blue staining	Procedure: US guidance and MB staining
Open surgery	Active Comparator	Open surgery without ultrasound guidance and methylene blue staining	Procedure: US guidance and MB staining

Interventions

Name	Type	Description	Arm Group Labels	Other Names
US guidance and MB staining	Procedure	Ultrasound guidance and methylene blue staining	Open surgery Ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgery time	Time from incision made to incision closure	Surgery end time

Secondary Outcomes

Measure	Description	Time Frame
Blood loss	The blood loss of all the surgery time	Surgery end time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with soft-tissue foreign body
Must have complete clinical data

Exclusion Criteria:

Had other injuries
Presented with more than 3 pieces foreign bodies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Chongqing Medical University		Chongqing	Chongqing Municipality	400014	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Foreign body removal with the assistance of ultrasound guidance and methylene blue staining in children

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided