Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB

NCT06725056 | Not Yet Recruiting

• 1 other identifier: DS-MCE for patients with AUGIB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Upper Gastrointestinal Bleeding; Capsule Endoscopes

Keywords

AUGIB; DS-MCE; emergency department

Outcome Measures

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.

  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

  From enrollment to the end of end of follow-up at 4 weeks

• The number of observed signs of bleeding

  From enrollment to the end of end of follow-up at 4 weeks

• Detection rate of bleeding lesions in enrolled subjects

  From enrollment to the end of end of follow-up at 4 weeks

• Detection rate of lesions in enrolled subjects

  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

  From enrollment to the end of end of follow-up at 4 weeks

Study Arms (1)

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.

Other: DS-MCE and EGD examinations

Interventions

DS-MCE and EGD examinations OTHER

sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics

group of participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai hospital

Shanghai, China

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhuan Liao

  Changhai Hospital

  STUDY CHAIR

Central Study Contacts

Yilin Han

CONTACT

+8615038655111; hanyl10@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: December 10, 2024
• Study Start: December 25, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)