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

November 7, 2022 updated by: Zhuan Liao, Changhai Hospital

Feasibility of Mini-sized Magnetically Controlled Capsule Endoscopy in Visualization of UGI and Small Bowel: a Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Magnetically controlled capsule endoscopy (MCE), with equally favorable diagnostic accuracy as conventional endoscopy, has become a painless noninvasive diagnostic modality in clinical practice. The more than 8 hours battery life of the MCE enables a further examination of the small bowel. In addition, it has been demonstrated that magnetic steering of capsule endoscopy improves the completion rate of small bowel examination by facilitating passage of the capsule through the pylorus, which further supported MCE as a practical modality for examination of both the stomach and small bowel. Previous studies have confirmed the great safety and efficacy of MCE for examination of patients with high-risk factors for standard gastroscopy, those long-time taking aspirin, aging patients and children.

However, this technique still has some limitations in clinical practice. Due to the large size of the capsule, some patients may be difficult to swallow the capsule, especially in children. A clinical trial reported that a certain number of children with ages ranging from 6 to 14 years fail to swallow the MCE by themselves for its big size (27mm*11.8mm). During the examination procedure of small bowel capsule endoscopy, measuring 26*11mm, in those under 10 years old of age, up to 87% of patients are unable to swallow the capsule. In adolescents, it is reported that more than one-third of patients have difficulties with swallowing standard size tablets. In addition, serious complications, such as aspiration of the capsule, often occur in the elderly who need more efforts to swallow the capsule. For those at any age unable or unwilling to swallow a capsule, endoscopic placement is required to deliver the capsule to the stomach or directly the duodenum. However, this procedure greatly increases patient's discomfort, examination costs and increase the risk associated with the endoscopic procedure, anesthesia. Thus, it is of great importance to make the capsule endoscopy easier to swallow in both children and adolescents.

Therefore, 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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients aged ≥18.
  • Scheduled to undergo a capsule endoscopy for both stomach and small bowel.
  • Signed the informed consents before joining this study.

Exclusion Criteria:

  • Dysphagia or symptoms of gastric outlet obstruction
  • Known or suspected GI obstruction, stenosis, or fistula
  • History of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
  • Implanted pacemaker, except the pacemaker is compatible with MRI
  • Other implanted electromedical devices or magnetic metal foreign bodies
  • Pregnancy or suspected pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: mini-sized MCE
Participants in this group underwent examination of mini-sized MCE.
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.
OTHER: normal-sized MCE
Participants in this group underwent examination of normal-sized MCE.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the difficulty score for swallowing the capsule
Time Frame: 6 months
The primary outcome was the difficulty score for swallowing the capsule, which was assessed on a visual analog scale ranging from 0 (very easy with no nausea) to 10 (very difficult or with severe nausea)
6 months
the time required to swallow the capsule
Time Frame: 6 months
The capsule swallowing time was defined as the time between the first mouth image and the first esophageal image.
6 months
the success rate for swallowing the capsule at the first attempt
Time Frame: 6 months
If the patient swallowed the capsule directly with a sip of water at the first attempt, it was defined as a success for swallowing the capsule at the first attempt; if the capsule entered the esophagus after several swallowing attempts or with endoscopic placement, it was defined as a failure.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of images captured for Z-line and quadrants of the Z-line
Time Frame: 6 months
Visualization of the esophagus indicated by the number of images captured for Z-line and how many quadrants of the Z-line were observed.
6 months
Visualization score of the gastric mucosa
Time Frame: 6 months
To objectively evaluate the complete visualization of the gastric mucosa in the 6 anatomic landmarks (cardia, fundus, body, angulus, antrum, and pylorus), a 3-point grading scale was used: 1, poor (<70% of the mucosa was observed), 2, fair (70%-90% of the mucosa was observed), and 3, good (>90% of the mucosa was observed).
6 months
Visualization of the small bowel
Time Frame: 6 months
Visualization of the small bowel was determined by the small bowel complete examination rate.
6 months
Difficulty score of swallowing the capsule
Time Frame: 1 month
To evaluate the difficulty score of swallowing the capsule. After the examination, the patient was asked to complete a questionnaire. A visual analogue scale ranging from 0 (easy with no nausea) to 10 (very difficult or with sever nausea) was used to evaluate the degree of difficulty of swallowing the capsule.
1 month
Gastrointestinal transit time
Time Frame: 1 month
Examination-related parameters included esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), pylorus transit time (PTT), small bowel transit time (SBTT). ETT is defined as the time between the first esophageal image and the first gastric image. GTT is defined as the time between the first gastric image and the first duodenal image. GET is defined as the time for examination of gastric primary anatomic landmarks twice. PTT is defined as the time between the first pyloric image and the first duodenal image. SBTT is defined as the time between the first duodenal image and the first cecal image.
1 month
Detection rate of lesions
Time Frame: 1 month
The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by mini-sized MCE and normal-sized MCE.
1 month
Safety of mini-sized MCE procedure:presence of any adverse events during mini-sized MCE procedure will be recorded
Time Frame: 1 month
presence of any adverse events during mini-sized MCE procedure will be recorded
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 12, 2021

Primary Completion (ACTUAL)

May 30, 2021

Study Completion (ACTUAL)

September 15, 2021

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (ACTUAL)

October 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • mini-MCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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