Acute Upper Gastrointestinal BleedingNCT06725056
Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB
A study testing DS-MCE and EGD examinations in people with Acute Upper Gastrointestinal Bleeding and Capsule Endoscopes, run by Changhai Hospital at 1 site in China.
Trial summary
Use CE for pre-examination of patients with AUGIB symptoms in emergency centers may reduce the need for emergency electronic gastroscopy and have certain advantages in clinical work. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Upper Gastrointestinal Bleeding, Capsule Endoscopes
- What is being tested?
- DS-MCE and EGD examinations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 31 Oct 2025
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No gender limit, age ≥ 18 years
- Presenting to the emergency department with melena or hematemesis
- Hemodynamically stable at presentation
- No endoscopic examination has been performed due to this bleeding
- Agree to participate in this clinical trial and sign an informed consent form
Who cannot join
- Patients with acute active massive bleeding or hemodynamic instability (blood pressure < 90 mmHg and heart rate > 120 beats per minute)
- Patients with Hematochezia
- Hemodynamics remained unstable after fluid resuscitation
- Known or suspected intestinal obstruction, stenosis, or fistula
- Severe motor disorders such as asthma, swallowing disorders, or gastric paralysis
- History of abdominal surgery that affects the normal structure of the digestive tract in the past
Show all 13Show fewer
- When capsule retention occurs, the problem cannot be solved through surgery due to subjective or objective reasons
- Implantable medical devices such as pacemakers, electronic cochlear implants, drug infusion pumps, and neural stimulators are installed inside the body, except for MRI compatible products
- Pregnant women
- Those who require MRI examination before capsule endoscopy discharge
- Suffering from severe cardiovascular and pulmonary diseases (such as severe myocardial infarction, arrhythmia, heart failure, and respiratory failure)
- Refuse MCE or gastroscopy examination
- The researchers believe that the subjects have any other factors that are not suitable for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Changhai hospital
Shanghai
Zhuan Liao, +86 13061921980, zhuanleo@126.com
About this study
Official title: Detachable String Magnetically Controlled Capsule Endoscopy for Patients with Acute Upper Gastrointestinal Bleeding: a Prospective Study
Use CE for pre-examination of patients with AUGIB symptoms in emergency centers may reduce the need for emergency electronic gastroscopy and have certain advantages in clinical work. Patients with low-risk lesions can be discharged without the need for EGD and hospitalization, greatly improving the utilization of medical resources.
Read the detailed description
The investigators plan to conduct exploratory research by sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding.
- Being tested
- DS-MCE and EGD examinations
- Keywords
- AUGIB, DS-MCE, emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-MCE and EGD examinationsOther
sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics
| Study group | Role | What they receive |
|---|---|---|
| group of participants | Experimental | Sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding. Receives: Other: DS-MCE and EGD examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of DS-MCE in detection active bleeding and bleeding lesions, using the detection of EGD as the gold standard,
Active bleeding is defined as the continuous flow of visible blood from damaged blood vessels under the microscope.
The detection results of bleeding lesions are divided into three categories: P0 refers to lesions without possible bleeding, such as visible submucosal veins, diverticula without bleeding traces, nodules without mucosal damage traces, etc; P1 refers to low-risk bleeding lesions, such as isolated erythema, isolated small erosions, or mucosal damage; P2 refers to high-risk bleeding lesions, such as peptic ulcers (active bleeding or visible blood vessels) with persistent or rebleeding risks, erosions with a diameter of ≥ 2mm, tumors, varicose veins, etc.
Measured: From enrollment to the end of end of follow-up at 4 weeks
Secondary outcomes (16)
The specificity of ds MCE in detecting active bleeding and bleeding lesions using EGD as the gold standard
Measured: From enrollment to the end of end of follow-up at 4 weeks
The number of observed signs of bleeding
Measured: From enrollment to the end of end of follow-up at 4 weeks
Detection rate of bleeding lesions in enrolled subjects
Measured: From enrollment to the end of end of follow-up at 4 weeks
Detection rate of lesions in enrolled subjects
Measured: From enrollment to the end of end of follow-up at 4 weeks
The time from the admission of subjects to the detection of bleeding lesions
Measured: From enrollment to the end of end of follow-up at 4 weeks
Number of therapeutic interventions (endoscopy, DSA, surgery) for enrolled subjects
Measured: From enrollment to the end of end of follow-up at 4 weeks
The time from the admission of subjects to the start of therapeutic interventions (endoscopy, DSA, surgery)
Measured: From enrollment to the end of end of follow-up at 4 weeks
Detection rate of esophageal, gastric, and small intestinal lesions in enrolled subjects
Measured: From enrollment to the end of end of follow-up at 4 weeks
Time of traditional electronic gastroscopy examination
Measured: From enrollment to the end of end of follow-up at 4 weeks
Time of DS-MCE examination
Measured: From enrollment to the end of end of follow-up at 4 weeks
Incidence of rebleeding in enrolled subjects 30 days after discharge
Measured: From enrollment to the end of end of follow-up at 4 weeks
Rate of all-cause mortality among enrolled subjects within 30 days of discharge
Measured: From enrollment to the end of end of follow-up at 4 weeks
Time of hospital stay for enrolled subjects
Measured: From enrollment to the end of end of follow-up at 4 weeks
Satisfaction of enrolled subjects
use a certain scale named satisfaction scale to measure the satisfaction of enrolled subjects (0-36), lower scores mean a better outcome.
Measured: From enrollment to the end of end of follow-up at 4 weeks
clinical safety (Incidence of Treatment-Emergent Adverse Events, Safety and Tolerability)
use the incidence of adverse events to measure clinical safety
Measured: From enrollment to the end of end of follow-up at 4 weeks
complication rate
Measured: From enrollment to the end of end of follow-up at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start25 Dec 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 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, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725056
- Sponsor's protocol ID
- DS-MCE for patients with AUGIB
- Status last verified
- Dec 2024
- First submitted
- 19 Oct 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detachable String Magnetically Controlled Capsule Endoscopy for Patients with Acute Upper Gastrointestinal Bleeding: a Prospective Study
- ClinicalTrials.gov ID
- NCT06725056
- Acronym / sponsor ID
- DS-MCE for patients with AUGIB
- Keywords
- AUGIB, DS-MCE, emergency department
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 25 Dec 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 10 Dec 2024 (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.
Use CE for pre-examination of patients with AUGIB symptoms in emergency centers may reduce the need for emergency electronic gastroscopy and have certain advantages in clinical work. Patients with low-risk lesions can be discharged without the need for EGD and hospitalization, greatly improving the utilization of medical resources.
Detailed description
The investigators plan to conduct exploratory research by sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group of participants | Experimental | Other: DS-MCE and EGD examinationsSequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- No gender limit, age ≥ 18 years
- Presenting to the emergency department with melena or hematemesis
- Hemodynamically stable at presentation
- No endoscopic examination has been performed due to this bleeding
- Agree to participate in this clinical trial and sign an informed consent form
Key exclusion criteria (13 listed)
- Patients with acute active massive bleeding or hemodynamic instability (blood pressure < 90 mmHg and heart rate > 120 beats per minute)
- Patients with Hematochezia
- Hemodynamics remained unstable after fluid resuscitation
- Known or suspected intestinal obstruction, stenosis, or fistula
- Severe motor disorders such as asthma, swallowing disorders, or gastric paralysis
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 |
|---|---|---|
| DS-MCE and EGD examinationssequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics | Other | group of participants |
Primary outcome
The sensitivity of DS-MCE in detection active bleeding and bleeding lesions, using the detection of EGD as the gold standard,
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Active bleeding is defined as the continuous flow of visible blood from damaged blood vessels under the microscope. The detection results of bleeding lesions are divided into three categories: P0 refers to lesions without possible bleeding, such as visible submucosal veins, diverticula without bleeding traces, nodules without mucosal damage traces, etc; P1 refers to low-risk bleeding lesions, such as isolated erythema, isolated small erosions, or mucosal damage; P2 refers to high-risk bleeding lesions, such as peptic ulcers (active bleeding or visible blood vessels) with persistent or rebleeding risks, erosions with a diameter of ≥ 2mm, tumors, varicose veins, etc.
16 secondary outcomes
The specificity of ds MCE in detecting active bleeding and bleeding lesions using EGD as the gold standard
Time frame: From enrollment to the end of end of follow-up at 4 weeks
The number of observed signs of bleeding
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Detection rate of bleeding lesions in enrolled subjects
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Detection rate of lesions in enrolled subjects
Time frame: From enrollment to the end of end of follow-up at 4 weeks
The time from the admission of subjects to the detection of bleeding lesions
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Number of therapeutic interventions (endoscopy, DSA, surgery) for enrolled subjects
Time frame: From enrollment to the end of end of follow-up at 4 weeks
The time from the admission of subjects to the start of therapeutic interventions (endoscopy, DSA, surgery)
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Detection rate of esophageal, gastric, and small intestinal lesions in enrolled subjects
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Time of traditional electronic gastroscopy examination
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Time of DS-MCE examination
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Incidence of rebleeding in enrolled subjects 30 days after discharge
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Rate of all-cause mortality among enrolled subjects within 30 days of discharge
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Time of hospital stay for enrolled subjects
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Satisfaction of enrolled subjects
Time frame: From enrollment to the end of end of follow-up at 4 weeks
clinical safety (Incidence of Treatment-Emergent Adverse Events, Safety and Tolerability)
Time frame: From enrollment to the end of end of follow-up at 4 weeks
complication rate
Time frame: From enrollment to the end of end of follow-up at 4 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 10 Dec 2024.
- 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.
Zhuan Liao study chair
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DS-MCE and EGD examinations in people with Acute Upper Gastrointestinal Bleeding and Capsule Endoscopes, run by Changhai 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 5 inclusion and 13 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 10 Dec 2024. 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?
Contact Yilin Han (+8615038655111, hanyl10@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity of DS-MCE in detection active bleeding and bleeding lesions, using the detection of EGD as the gold standard, (time frame: From enrollment to the end of end of follow-up at 4 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 10 Dec 2024.