Capsule Endoscopy
Conditions
Brief summary
Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial
Detailed description
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.
Interventions
DEVICEundergo NaviEC-2000Pro Gastro Scan mode
Patients undergo NaviEC-2000Pro Gastro Scan mode.
DEVICENaviEC-2000Pro Routine gastric examination
Patients undergo NaviEC-2000Pro Routine gastric examination mode.
DEVICENaviEC-1000 Routine gastric examination
Patients undergo NaviEC-1000 Routine gastric examination mode.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* underwent gastric examination; * At least 18 years old； * Be able to provide informed consent.
Exclusion criteria
* With swallowing obstruction or disorders; * With known or suspected gastrointestinal obstruction, stenosis and fistula; * Have no conditions for surgery or refuse to undergo any abdominal surgery; * Be allergic to or have other known contraindication or intolerance to the drug used in the study; * With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies; * Women during pregnancy; * Currently enrolled in another clinical trial of a drug or device; * Other conditions determined by the investigator to be inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the degree of gastric mucosal visualization | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time of gastric examination | 2 weeks | The total time MCE required to complete the stomach examination |
| detection of lesions | 2 weeks | The detection of gastric lesions by MCE |
| Equipment operation evaluation | 2 weeks | 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 |
| Safety Assessment | 2 weeks | Number and incidence of device-related adverse events and serious adverse events |
Contacts
Primary ContactZhuan Liao
Backup ContactYangyang Qian
Outcome results
None listed