Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB

Launched by CHANGHAI HOSPITAL · Dec 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to examine patients who have symptoms of acute upper gastrointestinal bleeding, which can include vomiting blood or passing dark, tarry stools. The researchers are testing a detachable string magnetically controlled capsule endoscopy (MCE) to see if it can be used in emergency rooms to check for bleeding in patients. The goal is to find out if this method can reduce the need for more invasive procedures, like traditional endoscopy, allowing some patients to go home safely without needing to stay in the hospital.

To participate in this trial, you need to be at least 18 years old and have symptoms like vomiting blood or dark stools while being stable, meaning your blood pressure and heart rate are normal. However, you won't be able to join if you have severe bleeding, certain medical conditions, or if you've had specific types of surgeries. If you do qualify and agree to take part, you'll be asked to sign a consent form. Throughout the trial, you can expect to have a non-invasive capsule procedure that may help doctors see inside your digestive tract without needing more invasive tests.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • 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