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Mini-sized MCE for Better Examination of UGI and Small Bowel

NCT05073536 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-11-10

No results posted yet for this study

Summary

A mini-sized MCE highlighted with a diameter of 9.5mm, a length of 24.5mm, and a weight of 3.0g has been developed. This new type of MCE is approximately 0.6 times the conventional MCE (27mm\*11.8mm) in volume and weight, and it is the smallest CE among all the reported capsules. Thus, this pilot study was conducted to clarify whether the mini-sized MCE can further optimize the process of swallowing the capsule and to verify whether the smaller size of the capsule will have influence on the examination procedure of the upper gastrointestinal tract and small intestine.

Conditions

  • Capsule Endoscopy

Interventions

DEVICE

mini-sized MCE

Enrolled participants were randomly allocated into the normal-sized MCE group or mini-sized MCE group in a 1:1 ratio.

DEVICE

normal-sized MCE

Enrolled participants were randomly allocated into the normal-sized MCE group or mini-sized MCE group in a 1:1 ratio.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Zhuan Liao, Professor · Changhai Hospital,Shanghai,China

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-12
Primary Completion
2021-05-30
Completion
2021-09-15

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 NCT05073536 on ClinicalTrials.gov