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

NCT ID: NCT05073536

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2021-09-15

Brief 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.

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.

Conditions

Capsule Endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

mini-sized MCE

Participants in this group underwent examination of mini-sized MCE.

Group Type: EXPERIMENTAL

mini-sized MCE

Intervention Type: DEVICE

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

normal-sized MCE

Participants in this group underwent examination of normal-sized MCE.

Group Type: OTHER

normal-sized MCE

Intervention Type: DEVICE

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

Interventions

mini-sized MCE

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Liao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhuan Liao, Professor

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital,Shanghai,China

Locations

Changhai Hospital

Shanghai, , China

Countries

China

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: DERIVED

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Other Identifiers

mini-MCE

Identifier Type: -

Identifier Source: org_study_id