Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB (NCT06725056) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB
China120 participantsStarted 2024-12-25
Plain-language 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. Patients with low-risk lesions can be discharged without the need for EGD and hospitalization, greatly improving the utilization of medical resources.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 partici…
What they're measuring
1
The sensitivity of DS-MCE in detection active bleeding and bleeding lesions, using the detection of EGD as the gold standard,
Timeframe: From enrollment to the end of end of follow-up at 4 weeks