Clinical trial NCT05073536: Mini-sized MCE for Better Examination of UGI and Small Bowel
Official title: Feasibility of Mini-sized Magnetically Controlled Capsule Endoscopy in Visualization of UGI and Small Bowel: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Capsule Endoscopy
Keywords: magnetically controlled capsule endoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
First posted: 2021-10-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: the difficulty score for swallowing the capsule
timeFrame: 6 months
measure: the time required to swallow the capsule
timeFrame: 6 months
measure: the success rate for swallowing the capsule at the first attempt
timeFrame: 6 months
Secondary outcomes:
measure: the number of images captured for Z-line and quadrants of the Z-line
timeFrame: 6 months
measure: Visualization score of the gastric mucosa
timeFrame: 6 months
measure: Visualization of the small bowel
timeFrame: 6 months
measure: Difficulty score of swallowing the capsule
timeFrame: 1 month
measure: Gastrointestinal transit time
timeFrame: 1 month
measure: Detection rate of lesions
timeFrame: 1 month
measure: Safety of mini-sized MCE procedure:presence of any adverse events during mini-sized MCE procedure will be recorded
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital,Shanghai,China
name: Zhuan Liao, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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