Gastric Polyp, Gastric Ulcer
Conditions
Brief summary
The present study is a feasibility study to assess the safety and efficacy of wireless capsule endoscope and compare the data obtained with those obtained by using a conventional esophagogastroduodenoscopy. The product was developed and manufacture in China.(the NaviCam. AKC-1.China)
Interventions
DEVICEmagnetic-controlled capsule endoscopy(Navicam)
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* upper abdominal symptoms (≥1 year ) * surveillance gastroscopy for known gastric ulcer or polyps * history of gastric ulcer or polyps （≤1w）at Nanfang Hospital were enrolled.
Exclusion criteria
* dysphagia * suspected or documented digestive tract malformation ,obstruction, strictures or fistula * acute upper GI bleeding, acute enteritis, acute ischemia disease * history of abdominal operations * impaired renal function, congestive heart failure * patients with critical condition or mental illness * patients with, known allergy to polymer material or antifoam agent * patients with cardiac pacemakers or other implanted electromedical devices，magnetic resonance imaging ( mri) examination in 7 days * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the percentage of complete visualization of anatomic landmarks | 2 year | the percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus |
| examination time and the percentage of abnormal finding | 2 year | examination time and the percentage of abnormal findings seen on gastroscopy that were reproducible by capsule endoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse effect | 2 year | any discomfort like chest pain, nausea will be documented. capsule retention（defined as not extrusion in 14 days）will be documented. |
| Acceptability | 2 year | Acceptability to patients was assessed by means of a questionnaire, with ratings on a scale of 0 to 10 and examination chosen for next time. completed in the recovery room immediately after capsule examination. |
Countries
China
Contacts
Primary Contactxinying Wang, Associate Professor
Outcome results
None listed