Mini-sized MCE for Detection of Small Bowel in Children Under the Age of 10 Years

Naval Military Medical University

Status: Not yet enrolling

Conditions: Small Bowel Disease

Treatments: Device: Normal-sized MCE; Device: Mini-sized MCE

Study type: Interventional

Funder types: Other

Identifiers

NCT05522101

Mini-sized MCE

Details and patient eligibility

About

In this prospective randomized controlled trial, pediatric volunteers were enrolled and randomly underwent mini-sized MCE and normal-sized CE to compare the success rate of self-swallowing between mini-sized MCE and normal-sized CE during gastrointestinal examination.

Full description

Magnetic controlled capsule endoscopy (MCE) is comparable to traditional gastroscopy (EGD) in the diagnosis of gastric diseases, and has been widely used in clinical practice. However, there are still some limitations in the application of MCE in digestive tract examination. Due to the large size of capsules at present, some patients have difficulty swallowing capsules during capsule swallowing, which leads to the failure of examination, and the proportion is higher in children patients. Therefore, in order to further improve the patient's comfort in swallowing capsules, our team developed a small MCE with a smaller size combined with innovation, which is 0.6 times of the conventional MCE in terms of volume and weight. This study aims to clarify the application efficacy of mini-MCE in gastrointestinal examination of adults and children through a multicenter clinical study comparing conventional capsule endoscopy with mini-magnetic-controlled capsule endoscopy. In order to ensure the efficacy of the capsule in the examination of digestive tract mucosa, and improve the ease of swallowing in children.

Enrollment: 158 estimated patients

Sex: All

Ages: 2 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients and their legal guardians agreed to participate in the study and signed informed consent;
• 2 years ≤ age < 10 years;
• Pediatric patients with suspected small bowel disease who are scheduled for small bowel capsule endoscopy

Exclusion criteria

• Intestinal obstruction, stenosis, or fistula is known or suspected;
• Dysphagia or gastric emptying dysfunction;
• Severe asthma, dysphagia or gastroparesis and other emptying disorders;
• Known or suspected possibility of major bleeding from active digestive tract;
• The presence of a pacemaker in the body, except where the pacemaker is a new MRI-compatible product;
• Implanted cochlear implants, magnetic metal drug infusion pumps, nerve stimulators and other electronic devices, as well as magnetic metal foreign bodies;
• Those who plan to undergo magnetic resonance imaging (MRI) examination before capsule endoscopy discharge;
• Previous history of abdominal surgery affecting the normal structure of the digestive tract;
• Patients with mental illness;
• Allergic to macromolecular materials such as dimethyl silicone oil;
• Refuse to use electronic gastroscopy to deliver the capsule to the duodenum if the capsule cannot be swallowed by itself;
• Contraindications of intravenous anesthesia;
• Patients who have participated in or are participating in other clinical trials within three months;
• Any other factors considered by the investigator to be inappropriate for enrollment or to affect the participant's participation in the study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups, including a placebo group

Mini-sized MCE

Experimental group

Description:

AKES-31SW Capsule Endoscopy

Treatment:

Device: Mini-sized MCE

Normal sized CE

Placebo Comparator group

Description:

PillCam Capsule Endoscopy

Treatment:

Device: Normal-sized MCE