MCE-new for Detection of Gastric Lesions

Naval Military Medical University

Status: Not yet enrolling

Conditions: Capsule Endoscopy

Treatments: Device: undergo NaviEC-2000Pro Gastro Scan mode; Device: NaviEC-1000 Routine gastric examination; Device: NaviEC-2000Pro Routine gastric examination

Study type: Interventional

Funder types: Other

Identifiers

NCT06020859

MCE-new

Details and patient eligibility

About

Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial

Full description

The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• underwent gastric examination;
• At least 18 years old；
• Be able to provide informed consent.

Exclusion criteria

• With swallowing obstruction or disorders;
• With known or suspected gastrointestinal obstruction, stenosis and fistula;
• Have no conditions for surgery or refuse to undergo any abdominal surgery;
• Be allergic to or have other known contraindication or intolerance to the drug used in the study;
• With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;
• Women during pregnancy;
• Currently enrolled in another clinical trial of a drug or device;
• Other conditions determined by the investigator to be inappropriate for enrollment.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

NaviEC-2000Pro Gastro Scan

Experimental group

Description:

NaviEC-2000Pro Gastro Scan is a new mode of NaviEC-2000Pro

Treatment:

Device: undergo NaviEC-2000Pro Gastro Scan mode

NaviEC-2000Pro Routine gastric examination

Experimental group

Description:

NaviEC-2000Pro Routine gastric examination is a mode of NaviEC-2000Pro

Treatment:

Device: NaviEC-2000Pro Routine gastric examination

NaviEC-1000 Routine gastric examination

Active Comparator group

Description:

NaviEC-1000 Routine gastric examination is a mode of NaviEC-1000

Treatment:

Device: NaviEC-1000 Routine gastric examination