Self-propelling capsule endoscopy

JRCT ID: jRCTs052180023

Registered date:10/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 01/11/2018
• Target sample size: 30
• Study type: Interventional

Intervention(s)

As a pretreatment, internal administration of 24 mg of sennoside at 21:00 on the day before the examination and 2 L of intestinal tract wash at 7:00 on the examination day will be conducted.
Swallowing SPCE at 10:00 on the examination day.
(1) Observation of the stomach: After drinking water 500 ml, observe while changing the position.
(2) Small intestine: Observed in supine position.
(3) Large intestine: After reaching the cecum, 2 L intestinal tract is administered, and the cecum is expanded and observed in the supine position.

Outcome(s)

• Primary Outcome: Transit time of each organ

Secondary Outcome

Transparency of intestinal fluid by premedication (Excellent: No residue, Good: Some residue but no problem in observation, Fair: Some residue but sufficient observation, Poor: Insufficient observation with residue) and safety.
The evaluation in each subject will be performed in stages, such as to the stomach, small intestine, and colon.

In order to confirm how the self-propelled capsule endoscope actually moves in the stomach, the nasal mucosa is anesthetized and the transnasal endoscope is inserted to move the capsule endoscope and observe directly(Subjects with consent only).
Transnasal endoscopy takes about 10 minutes. As an evaluation of the movement of the self-propelled capsule endoscope by the nasal endoscope, it is evaluated whether the three-dimensional direction change, the amplitude of the fin, etc. are moving according to the operation of the controller.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Healthy adults without disease history
• Exclude criteria: 1) a possibility of gastrointestinal obstruction or stenosis such as nausea, vomiting or abdominal fullness feeling,2) a history of gastrointestinal disorders such as Crohn's disease, 3) a history of the operation history of the abdomen, 4) a history of radiotherapy of the pelvic area,5) a cardiac pacemaker or other electro-medical device is implanted,6) in case of swallowing disorder, 7) periodic oral doses of NSAIDs, 8) women who are pregnant or potentially pregnant.

Related Information

• Primary Sponsor: Higuchi Kazuhide
• Secondary ID(s): UMIN000027805