Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-contact MCE examination | Experimental | Study subject in this arm receives non-contact MCE examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-contact MCE system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Maneuvarability of the remote control MCE system | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success | Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus | During the procedure |
| Adverse events | Adverse events during and after the procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhuan Liao, MD | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32160451 | Background | Hollander JE, Carr BG. Virtually Perfect? Telemedicine for Covid-19. N Engl J Med. 2020 Apr 30;382(18):1679-1681. doi: 10.1056/NEJMp2003539. Epub 2020 Mar 11. No abstract available. | |
| 27211503 | Background | Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| During and within 2 weeks after the procedure |
| 29753039 | Background | Zhao AJ, Qian YY, Sun H, Hou X, Pan J, Liu X, Zhou W, Chen YZ, Jiang X, Li ZS, Liao Z. Screening for gastric cancer with magnetically controlled capsule gastroscopy in asymptomatic individuals. Gastrointest Endosc. 2018 Sep;88(3):466-474.e1. doi: 10.1016/j.gie.2018.05.003. Epub 2018 May 9. |
| 31511198 | Background | Tai FWD, Ching HL, Hale MF, McAlindon ME. Upper gastrointestinal endoscopy: can we cut the cord? Lancet Gastroenterol Hepatol. 2019 Oct;4(10):749-751. doi: 10.1016/S2468-1253(19)30262-6. No abstract available. |
| 30005825 | Background | Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |