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Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial
The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaviEC-2000Pro Gastro Scan | Experimental | NaviEC-2000Pro Gastro Scan is a new mode of NaviEC-2000Pro |
|
| NaviEC-2000Pro Routine gastric examination | Experimental | NaviEC-2000Pro Routine gastric examination is a mode of NaviEC-2000Pro |
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| NaviEC-1000 Routine gastric examination | Active Comparator | NaviEC-1000 Routine gastric examination is a mode of NaviEC-1000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| undergo NaviEC-2000Pro Gastro Scan mode | Device | Patients undergo NaviEC-2000Pro Gastro Scan mode. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the degree of gastric mucosal visualization | The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, <70% of the gastric mucosa can be observed. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The time of gastric examination | The total time MCE required to complete the stomach examination | 2 weeks |
| detection of lesions | The detection of gastric lesions by MCE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhuan Liao | Contact | 86-21-31161004 | liaozhuan@smmu.edu.cn | |
| Yangyang Qian | Contact |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 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. |
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| NaviEC-2000Pro Routine gastric examination | Device | Patients undergo NaviEC-2000Pro Routine gastric examination mode. |
|
| NaviEC-1000 Routine gastric examination | Device | Patients undergo NaviEC-1000 Routine gastric examination mode. |
|
| 2 weeks |
| Equipment operation evaluation | Operation fluency is defined as the smooth response between operation and real-time capsule shooting. Stability is defined as the stable ability to control the capsule in a fixed position; Comfort is defined as the operator's operating comfort during examination. They were all rated on a scale of 1-5, with 1 being the worst and 5 the best | 2 weeks |
| Safety Assessment | Number and incidence of device-related adverse events and serious adverse events | 2 weeks |