Self-propelling capsule endoscopy

Phase 1

• Conditions: ot applicable

• Registration Number: JPRN-jRCTs052180023
• Lead Sponsor: Higuchi Kazuhide

Brief Summary

To resolve the problems associated with the existing self-propelling capsule endoscope, it may be necessary to not only improve the capsule endoscopes, but also control the environment within the gastrointestinal tract with medications and other means. Our results could guide other researchers develop capsule endoscopes controllable from outside the body, thus allowing real-time observation.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-10
• Study Completion: 2021-02-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Healthy adults without disease history

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transit time of each organ

Secondary Outcome Measures

Name	Time	Method
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.<br>The evaluation in each subject will be performed in stages, such as to the stomach, small intestine, and colon.<br><br>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).<br>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.