Foreign Body IngestionNCT07649382
A Novel Strategy for Endoscopic Dual-instrument Retrieval of Upper GI Foreign Body
An observational study of Foreign Body Ingestion, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
We describe a single-center, retrospective case series (n = 10) for the utilization of dual instruments to extract foreign body at physiological narrowing. Foreign bodies that failed to remove with a single instrument or located in physiological narrowing into the duodenal bulb or descending duodenum were considered… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Foreign Body Ingestion
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In this study, we retrospectively examined the records of 10 patients who underwent endoscopic foreign body extraction at Zhongshan Hospital, Fudan University between January 2018 and January 2026. All patients initially presented to the emergency department and underwent an initial single-instrument endoscopic retrieval attempt. When single-instrument retrieval was unsuccessful or unstable, a dual-instrument endoscopic retrieval technique was subsequently applied. All procedures were performed by a single experienced therapeutic endoscopist.
Who may be able to join
- -Consecutive patients who underwent dual-instrument endoscopic retrieval for upper gastrointestinal foreign bodies at our center during the study period.
Who cannot join
- -Patients with incomplete clinical or procedural records. Patients lost to follow-up immediately after the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
We describe a single-center, retrospective case series (n = 10) for the utilization of dual instruments to extract foreign body at physiological narrowing. Foreign bodies that failed to remove with a single instrument or located in physiological narrowing into the duodenal bulb or descending duodenum were considered appropriate for this technique. Informed consent was obtained from all patients before the procedure.
- Conditions
- Foreign Body Ingestion
- Keywords
- foreign body
- Medical subject headings
- Foreign Bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dual-instrument | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Endoscopic Foreign Body Removal Rate
Percentage of patients in whom the foreign body is completely removed using the dual-instrument endoscopic retrieval technique without the need for surgical intervention. Success will be assessed by direct endoscopic visualization and procedural records.
Measured: 1 day
Secondary outcomes (1)
Procedure-Related Adverse Event Rate
Percentage of patients experiencing procedure-related adverse events, including mucosal injury, bleeding, perforation, aspiration, or infection. Adverse events will be assessed based on endoscopic findings, clinical evaluation, and post-procedural medical records.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foreign Body IngestionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan-Lin Li, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649382
- Sponsor's protocol ID
- B2026-537
- Status last verified
- Oct 2025
- First submitted
- 8 Jun 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Yu S, Wang X, Chen X. Removal of giant spherical foreign body in the esophagus by double-forceps endoscope and double balloon. J Int Med Res. 2020;48(8):0300060520941332. doi:10.1177/0300060520941332 2. Birk M, Bauerfeind P, Deprez P, et al. Removal of foreign bodies in the upper gastrointestinal tract in adults: European society of gastrointestinal endoscopy (ESGE) clinical guideline. Endoscopy. 2016;48(05):489-496. doi:10.1055/s-0042-100456 3. Emara M, Darwiesh E, Refaey M, Galal S. Endoscopic removal of foreign bodies from the upper gastrointestinal tract: 5-year experience. CEG. Published online July 2014:249. doi:10.2147/CEG.S63274
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Strategy for Endoscopic Dual-instrument Retrieval of Upper GI Foreign Body
- ClinicalTrials.gov ID
- NCT07649382
- Acronym / sponsor ID
- B2026-537
- Conditions
- Foreign Body Ingestion
- Keywords
- foreign body
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jun 2026 (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.
We describe a single-center, retrospective case series (n = 10) for the utilization of dual instruments to extract foreign body at physiological narrowing. Foreign bodies that failed to remove with a single instrument or located in physiological narrowing into the duodenal bulb or descending duodenum were considered appropriate for this technique. Informed consent was obtained from all patients before the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dual-instrument | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In this study, we retrospectively examined the records of 10 patients who underwent endoscopic foreign body extraction at Zhongshan Hospital, Fudan University between January 2018 and January 2026. All patients initially presented to the emergency department and underwent an initial single-instrument endoscopic retrieval attempt. When single-instrument retrieval was unsuccessful or unstable, a dual-instrument endoscopic retrieval technique was subsequently applied. All procedures were performed by a single experienced therapeutic endoscopist.
Key inclusion criteria (1 listed)
- -Consecutive patients who underwent dual-instrument endoscopic retrieval for upper gastrointestinal foreign bodies at our center during the study period.
Key exclusion criteria (1 listed)
- -Patients with incomplete clinical or procedural records. Patients lost to follow-up immediately after the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful Endoscopic Foreign Body Removal Rate
Time frame: 1 day
Percentage of patients in whom the foreign body is completely removed using the dual-instrument endoscopic retrieval technique without the need for surgical intervention. Success will be assessed by direct endoscopic visualization and procedural records.
1 secondary outcome
Procedure-Related Adverse Event Rate
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background1. Yu S, Wang X, Chen X. Removal of giant spherical foreign body in the esophagus by double-forceps endoscope and double balloon. J Int Med Res. 2020;48(8):0300060520941332. doi:10.1177/0300060520941332 2. Birk M, Bauerfeind P, Deprez P, et al. Removal of foreign bodies in the upper gastrointestinal tract in adults: European society of gastrointestinal endoscopy (ESGE) clinical guideline. Endoscopy. 2016;48(05):489-496. doi:10.1055/s-0042-100456 3. Emara M, Darwiesh E, Refaey M, Galal S. Endoscopic removal of foreign bodies from the upper gastrointestinal tract: 5-year experience. CEG. Published online July 2014:249. doi:10.2147/CEG.S63274
- Individual participant dataSharing planned: No
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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?
An observational study of Foreign Body Ingestion, run by Shanghai Zhongshan Hospital 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Successful Endoscopic Foreign Body Removal Rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07649382, which also lists 1 linked publication.
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 5 Aug 2026.