An interventional study of Non-contact MCE system in Gastrointestinal Disease and Infectious Disease, sponsored by Changhai Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-17.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Other
The COVID-19 outbreak and spread throughout the world now constitutes a global public health emergency. Direct contact between doctors and patients in daily practice bears potential risk of Covid-19 infection, and telemedicine, or non-contact medicine, in this circumstance, offers an ideal solution. Remote controlling capsule endoscopy system for gastric examination was recently developed and applicated in clinical practice.
The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, China) adds a remote control workstation and a audio-visual exchange system to the original well-establish MCE system, which consists of a robotic magnetic arm, a workstation (now bypassed) and a capsule endoscope, and boasts a 90% sensitivity and 94% specificity for diagnosing gastric focal lesions. This feasibility study aims to evaluate the technical success, clinical success and adverse events of the first clinical application of non-contact MCE system.
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This study's enrollment of 5 is below the median of 122 across 2,718 interventional studies indexed under Communicable Diseases.
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Study subject in this arm receives non-contact MCE examination.
Device: Non-contact MCE system
After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the study subject positions himself (herself) on the examination bed in Room A, while the operating doctor sits in Room B at the remote control workstation instructing her to swallow the capsule via the audio-visual exchange system. After the capsule entering the stomach, the doctor manipulated the two joysticks on the remote control workstation, mobilizing the robotic magnetic arm, and simultaneously driving the precise movement and rotation of the capsule to perform the gastric examination.
Technical success
Maneuvarability of the remote control MCE system
Time frame: During the procedure
Clinical success
Complete observation of the mucosa (\>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus
Time frame: During the procedure
Adverse events
Adverse events during and after the procedure
Time frame: During and within 2 weeks after the procedure
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Changhai Hospital