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

NCT05522101 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2022-10-14

No results posted yet for this study

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.

Conditions

  • Small Bowel Disease

Interventions

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.

Sponsors & Collaborators

  • Shanghai Children's Hospital

    collaborator OTHER

  • Xian Children's Hospital

    collaborator OTHER_GOV

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Zhuan Liao · Changhai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2023-07-20
Completion
2023-07-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05522101 on ClinicalTrials.gov