Gastrointestinal BleedingNCT07481591
Capsule Endoscopy in GI Bleeding: A Retrospective Study
An observational study of Gastrointestinal Bleeding, run by Changhai Hospital.
Trial summary
The goal of this observational study is to evaluate the diagnostic value and safety of capsule endoscopy in patients with gastrointestinal bleeding. The main questions it aims to answer are: What is the overall detection rate of bleeding lesions using capsule endoscopy? What is the completion rate of capsule… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Bleeding
- What is being tested?
- capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 15 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who underwent magnetically controlled capsule endoscopy for gastrointestinal bleeding at Changhai Hospital between January 2021 and December 2025
Who may be able to join
- Age ≥18 years old;
- Obvious symptoms of gastrointestinal bleeding (such as hematemesis, melena, hematochezia, and positive fecal occult blood test);
- From January 2021 to December 2025, magnetic capsule endoscopy was performed at Chang Hai Hospital
Who cannot join
- Known or suspected intestinal obstruction, stenosis, or fistula;
- Severe asthma, swallowing disorders, or gastroparesis and other motility disorders;
- History of abdominal surgery that has affected the normal structure of the digestive tract in the past;
- When capsule retention occurs, the problem cannot be solved through surgical means due to subjective or objective reasons;
- Implantable medical devices such as pacemakers, cochlear implants, drug infusion pumps, and nerve stimulators are installed inside the body, except for MRI compatible products;
- Pregnant women;
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- Patients who need to undergo MRI examination before capsule endoscopy is discharged;
- Suffering from severe heart and lung diseases (severe myocardial infarction, arrhythmia, heart failure, respiratory failure, etc.);
- Refusing capsule endoscopy or gastroscopy examination;
- Researchers believe that there are any other influencing factors that are not suitable for participants to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Retrospective Analysis of the Diagnostic Value of Capsule Endoscopy in Patients With Gastrointestinal Bleeding
The goal of this observational study is to evaluate the diagnostic value and safety of capsule endoscopy in patients with gastrointestinal bleeding. The main questions it aims to answer are:
What is the overall detection rate of bleeding lesions using capsule endoscopy? What is the completion rate of capsule endoscopy, and how long does it take for the capsule to pass through the stomach and small intestine? What adverse events (such as capsule retention) occur during or after the procedure?
Read more
Participants who underwent capsule endoscopy for gastrointestinal bleeding at Changhai Hospital between January 2021 and December 2025 will:
Have their existing medical records (including endoscopy reports, procedure notes, and follow-up records) reviewed by researchers Have their personal information anonymized and protected Not be required to undergo any additional tests, procedures, or visits This is a retrospective study that only analyzes previously collected data. No new interventions or patient contact is involved.
- Conditions
- Gastrointestinal Bleeding
- Being tested
- capsule endoscopy
- Keywords
- gastrointestinal bleeding, retrospective study, capsule endoscopy
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsule endoscopyDevice
This study involves a retrospective analysis of existing data from patients who underwent small-bowel capsule endoscopy for gastrointestinal bleeding between 2021-2025. No new intervention is administered.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective GI Bleeding Cohort | Patients aged ≥18 years who underwent capsule endoscopy for gastrointestinal bleeding at Changhain Hospital from January 2021 to December 2025. This study was a retrospective medical record analysis without any intervention measures. Receives: Device: capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of capsule endoscopy for lesions causing gastrointestinal bleeding.
Definition: The proportion of cases among all those included in the analysis where capsule endoscopy identified at least one positive lesion
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (3)
Detection rate of other lesions
Calculate the lesion detection rates for the esophagus, stomach, small intestine (further divided into jejunum and ileum), and colorectum separately.
The patients were divided into overt bleeding group and occult bleeding group, and the differences in lesion detection rates between the two groups were compared.
Measured: From enrollment to the end of treatment at 2 weeks
Completion Rate of Inspections:
Definition: The proportion of capsules that successfully pass through the stomach into the duodenum and complete the examination of the entire small intestine before the battery runs out.
Gastric transit time and intestinal transit time:
Definition: Record the time capsule stays in the stomach and the duration of its movement in the small intestine.
Measured: From enrollment to the end of treatment at 2 weeks
Safety Evaluation:
Adverse event incidence rate.
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, Principal investigator, Department of Gastroenterology, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481591
- Sponsor's protocol ID
- GIB-CE-Retro
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Diagnostic Value of Capsule Endoscopy in Patients With Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT07481591
- Acronym / sponsor ID
- GIB-CE-Retro
- Conditions
- Gastrointestinal Bleeding
- Keywords
- gastrointestinal bleeding, retrospective study, capsule endoscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 19 Mar 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.
The goal of this observational study is to evaluate the diagnostic value and safety of capsule endoscopy in patients with gastrointestinal bleeding. The main questions it aims to answer are:
What is the overall detection rate of bleeding lesions using capsule endoscopy? What is the completion rate of capsule endoscopy, and how long does it take for the capsule to pass through the stomach and small intestine? What adverse events (such as capsule retention) occur during or after the procedure?
Participants who underwent capsule endoscopy for gastrointestinal bleeding at Changhai Hospital between January 2021 and December 2025 will:
Have their existing medical records (including endoscopy reports, procedure notes, and follow-up records) reviewed by researchers Have their personal information anonymized and protected Not be required to undergo any additional tests, procedures, or visits This is a retrospective study that only analyzes previously collected data. No new interventions or patient contact is involved.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective GI Bleeding Cohort | – | Device: capsule endoscopyPatients aged ≥18 years who underwent capsule endoscopy for gastrointestinal bleeding at Changhain Hospital from January 2021 to December 2025. This study was a retrospective medical record analysis without any intervention measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who underwent magnetically controlled capsule endoscopy for gastrointestinal bleeding at Changhai Hospital between January 2021 and December 2025
Key inclusion criteria (3 listed)
- Age ≥18 years old;
- Obvious symptoms of gastrointestinal bleeding (such as hematemesis, melena, hematochezia, and positive fecal occult blood test);
- From January 2021 to December 2025, magnetic capsule endoscopy was performed at Chang Hai Hospital
Key exclusion criteria (10 listed)
- Known or suspected intestinal obstruction, stenosis, or fistula;
- Severe asthma, swallowing disorders, or gastroparesis and other motility disorders;
- History of abdominal surgery that has affected the normal structure of the digestive tract in the past;
- When capsule retention occurs, the problem cannot be solved through surgical means due to subjective or objective reasons;
- Implantable medical devices such as pacemakers, cochlear implants, drug infusion pumps, and nerve stimulators are installed inside the body, except for MRI compatible products;
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 |
|---|---|---|
| capsule endoscopyThis study involves a retrospective analysis of existing data from patients who underwent small-bowel capsule endoscopy for gastrointestinal bleeding between 2021-2025. No new intervention is administered. | Device | Retrospective GI Bleeding Cohort |
Primary outcome
The detection rate of capsule endoscopy for lesions causing gastrointestinal bleeding.
Time frame: From enrollment to the end of treatment at 2 weeks
Definition: The proportion of cases among all those included in the analysis where capsule endoscopy identified at least one positive lesion
3 secondary outcomes
Detection rate of other lesions
Time frame: From enrollment to the end of treatment at 2 weeks
Completion Rate of Inspections:
Time frame: From enrollment to the end of treatment at 2 weeks
Safety Evaluation:
Time frame: From enrollment to the end of treatment at 2 weeks
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 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Zhuan Liao principal investigator
Department of Gastroenterology, Changhai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Bleeding, run by Changhai Hospital.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Zhuan Liao (130 6192 1980, zhuanleo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection rate of capsule endoscopy for lesions causing gastrointestinal bleeding. (time frame: From enrollment to the end of treatment at 2 weeks). 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 19 Mar 2026.