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Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB

NCT ID: NCT06725056

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-25

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Acute Upper Gastrointestinal Bleeding Capsule Endoscopes

Keywords

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AUGIB DS-MCE emergency department

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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group of participants

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.

Group Type EXPERIMENTAL

DS-MCE and EGD examinations

Intervention Type OTHER

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

Interventions

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DS-MCE and EGD examinations

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhuan Liao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhuan Liao

Role: STUDY_CHAIR

Changhai Hospital

Locations

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Changhai hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Yilin Han

Role: CONTACT

Phone: +8615038655111

Email: [email protected]

Facility Contacts

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Zhuan Liao

Role: primary

Other Identifiers

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DS-MCE for patients with AUGIB

Identifier Type: -

Identifier Source: org_study_id