NCT05522101

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

Mini-sized Magnetically Controlled Capsule Endoscopy vs. Normal-sized CE for Detection of Small Bowel in Children Under the Age of 10 Years：A Prospective，Multi-center，Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Small Bowel Disease

Interventions

Type	Name	Description
DEVICE	Mini-sized MCE	AKES-31SW capsule endoscopy（Mini-sized MCE), its diameter is 9.5mm, length is 24.5mm, weight is 3.0g, shooting frequency is 0.5-6fps, image resolution is 480\*480, working time is not less than 8 hours. Mini-sized MCE is 0.6 times of traditional MCE in volume and weight, which is the smallest capsule in clinical application
DEVICE	Normal-sized MCE	Pillcam SB 3 capsule endoscopy（Normal-sized MCE), its diameter is 11.4mm, length is 26.2mm, weight is 3.0g, shooting frequency is 2-6fps, image resolution is 340\*340, working time is not less than 8 hours.

Timeline

• Start date: 2022-10-20
• Primary completion: 2023-07-20
• Completion: 2023-07-20
• First posted: 2022-08-30
• Last updated: 2022-10-14

Locations

4 sites across 1 country: China