Non-contact Endoscopy at Covid-19 Outbreak
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04320953 |
Recruitment Status :
Completed
First Posted : March 25, 2020
Last Update Posted : April 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Gastrointestinal Disease Infectious Disease | Device: Non-contact MCE system | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Non-contact Endoscopy at Covid-19 Outbreak |
Actual Study Start Date : | March 16, 2020 |
Actual Primary Completion Date : | March 26, 2020 |
Actual Study Completion Date : | April 9, 2020 |

Arm | Intervention/treatment |
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Experimental: Non-contact MCE examination
Study subject in this arm receives non-contact MCE examination.
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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 [ Time Frame: During the procedure ]Maneuvarability of the remote control MCE system
- Clinical success [ Time Frame: During the procedure ]Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus
- Adverse events [ Time Frame: During and within 2 weeks after the procedure ]Adverse events during and after the procedure

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Signed the informed consents before joining this study
Exclusion Criteria:
- Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
- Refused abdominal surgery to take out the capsule in case of capsule retention
- Implanted pacemaker, except the pacemaker is compatible with MRI
- Other implanted electromedical devices or magnetic metal foreign bodies
- Pregnancy or suspected pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320953
China | |
Changhai Hospital | |
Shanghai, China, 200433 |
Principal Investigator: | Zhuan Liao, MD | Changhai Hospital |
Responsible Party: | Zhuan Liao, Principal Investigator, Changhai Hospital |
ClinicalTrials.gov Identifier: | NCT04320953 |
Other Study ID Numbers: |
ncMCE1 |
First Posted: | March 25, 2020 Key Record Dates |
Last Update Posted: | April 17, 2020 |
Last Verified: | April 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Communicable Diseases Infections Gastrointestinal Diseases |
Digestive System Diseases Disease Attributes Pathologic Processes |