Foreign BodiesNCT05085509
Foreign Body Removal With the Assistance of Ultrasound Guidance and Methylene Blue Staining in Children
A study testing US guidance and MB staining in people with Foreign Bodies and Ultrasound, run by Yuxi Su at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Foreign Bodies, Ultrasound
- What is being tested?
- US guidance and MB staining
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with soft-tissue foreign body
- Must have complete clinical data
Who cannot join
- Had other injuries
- Presented with more than 3 pieces foreign bodies
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
About this study
Official title: Foreign Body Removal With the Assistance of Ultrasound Guidance and Methylene Blue Staining
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.
- Conditions
- Foreign Bodies, Ultrasound
- Being tested
- US guidance and MB staining
- Medical subject headings
- Foreign Bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US guidance and MB stainingProcedure or surgery
Ultrasound guidance and methylene blue staining
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Ultrasound guidance and methylene blue staining Receives: Procedure: US guidance and MB staining |
| Open surgery | Active comparator | Open surgery without ultrasound guidance and methylene blue staining Receives: Procedure: US guidance and MB staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery time
Time from incision made to incision closure
Measured: Surgery end time
Secondary outcomes (1)
Blood loss
The blood loss of all the surgery time
Measured: Surgery end time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 May 2016
- Primary completion1 May 2016
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign BodiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuxi Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuxi Su, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085509
- Sponsor's protocol ID
- CQMU-20210016
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Foreign body removal with the assistance of ultrasound guidance and methylene blue staining in children
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foreign Body Removal With the Assistance of Ultrasound Guidance and Methylene Blue Staining
- ClinicalTrials.gov ID
- NCT05085509
- Acronym / sponsor ID
- CQMU-20210016
- Conditions
- Foreign Bodies, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yuxi SuUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Procedure: US guidance and MB stainingUltrasound guidance and methylene blue staining |
| Open surgery | Active comparator | Procedure: US guidance and MB stainingOpen surgery without ultrasound guidance and methylene blue staining |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosed with soft-tissue foreign body
- Must have complete clinical data
Key exclusion criteria (2 listed)
- Had other injuries
- Presented with more than 3 pieces foreign bodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US guidance and MB stainingUltrasound guidance and methylene blue staining | Procedure or surgery | Open surgery, Ultrasound |
Primary outcome
Surgery time
Time frame: Surgery end time
Time from incision made to incision closure
1 secondary outcome
Blood loss
Time frame: Surgery end time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: Undecided. Foreign body removal with the assistance of ultrasound guidance and methylene blue staining in children
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US guidance and MB staining in people with Foreign Bodies and Ultrasound, run by Yuxi Su at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery time (time frame: Surgery end time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.