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

NCT05522101 | Unknown

• 1 other identifier: Mini-sized MCE
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Children; Small Bowel Disease; Capsule Endoscopy

Outcome Measures

Primary Outcomes (1)

• Success rate of self-swallowing with Mini-sized MCE

  Self-swallowing was defined as the subjects swallowing capsules for examination by themselves, and no endoscope or other instruments were needed to place capsules during the entire examination process

  2 weeks

Secondary Outcomes (20)

• Completion rate of capsule endoscopy gastric examination in two groups

  2 weeks

• Completion rate of small bowel examination by capsule endoscopy in two groups

  2 weeks

• Success rate of instrument-assisted examination in the two groups

  2 weeks

• Two groups of capsule endoscopy swallowing time

  2 weeks

• Two groups of capsule endoscopy swallowing intake of water

  2 weeks

Study Arms (2)

Mini-sized MCE

EXPERIMENTAL

AKES-31SW Capsule Endoscopy

Device: Mini-sized MCE

Normal sized CE

PLACEBO COMPARATOR

PillCam Capsule Endoscopy

Device: Normal-sized MCE

Interventions

Mini-sized MCE DEVICE

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

Mini-sized MCE

Normal-sized MCE DEVICE

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.

Normal sized CE

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Shanghai Children's Hospital: collaborator
• Xian Children's Hospital: collaborator

Study Sites (4)

Qilu Children's Hospital

Jinan, China

Location

Shanghai Changhai Hospital

Shanghai, China

Location

Shanghai Children's Hospital

Shanghai, China

Location

Xi'an Children's Hospital

Xi'an, China

Location

Related Publications (17)

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  PMID: 30747810 BACKGROUND

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  PMID: 30184608 BACKGROUND

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  PMID: 31365487 BACKGROUND

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  PMID: 24777427 BACKGROUND

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  PMID: 31205466 BACKGROUND

• Fritscher-Ravens A, Scherbakov P, Bufler P, Torroni F, Ruuska T, Nuutinen H, Thomson M, Tabbers M, Milla P. The feasibility of wireless capsule endoscopy in detecting small intestinal pathology in children under the age of 8 years: a multicentre European study. Gut. 2009 Nov;58(11):1467-72. doi: 10.1136/gut.2009.177774. Epub 2009 Jul 21.

  PMID: 19625281 BACKGROUND

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Study Officials

• Zhuan Liao

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuan Liao

CONTACT

86-21-31161004; liaozhuan@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 30, 2022
• Study Start: October 20, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 years
• Access Criteria: The website of the journal where the results published,and ClinicalTrials.gov web site.

Locations

CN (4)