Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChanghai Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
DS-MCE and EGD examinations
Other interventionsequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: group of participantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of end of follow-up at 4 weeksSecondary outcomes
1
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 weeks2
The number of observed signs of bleeding
Time frame
From enrollment to the end of end of follow-up at 4 weeks3
Detection rate of bleeding lesions in enrolled subjects
Time frame
From enrollment to the end of end of follow-up at 4 weeks4
Detection rate of lesions in enrolled subjects
Time frame
From enrollment to the end of end of follow-up at 4 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: