Capsule Endoscopy
Conditions
Keywords
Capsule endoscopy, Patient position changing
Brief summary
It is a single center, prospective and self-controlled trial. We'd like to explore a new method by changing position to reduce gastric missing areas in Capsule Endoscopy(CE)
Detailed description
Background:Capsule endoscopy is widely used to observe small intestine.While it may miss important areas in stomach，especially in fundus.So far,physicians have no methods to observe stomach without no-missing areas by capsule endoscopy. Objective:To explore a new method to reduce the areas missed by CE. Methods:Subjects were prospectively enrolled.Every subjects will undergo 2 capsule endoscopies and 1 gastroscope.First capsule endoscopy,every subject have a better gastric preparation before swallowing CE and change position during the procedure.Second capsule endoscopy,every subject have a conventional CE. And then, every subject have a gastroscope. Measurements:The primary measurements included safety, gastric preparation, visualization of gastric mucosa and rate of lesion detection.
Interventions
BEHAVIORALPosition changing
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects don't have swallowing difficulties, motility disorders, or a medical history that included abdominal surgery or obvious gastrointestinal strictures are included.
Exclusion criteria
* Subjects with swallowing difficulty, motility disorders, diabetes, life-threatening conditions, mental disorders, or patients that could be pregnant, have a cardiac pacemaker, electrical implant, or any other condition that would preclude compliance with the study requirements and/or device instructions are excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visualization of gastric mucosa | 1 year | Gastric preparation included the degree of cleanliness and distention.Cleanliness was evaluated by 3 grades: good (the fluid was transparent and \<5% of gastric mucosa was obscured by stomach contents), moderate (the fluid was a little opaque or 5% to 10% of gastric mucosa was obscured by stomach contents) and poor (the fluid was opaque or \>10% of gastric mucosa was obscured by stomach contents). Distention was evaluated by 3 grades: good (existence of a small amount of gastric folds), moderate (existence of significant amount of gastric folds and gastric cavity was smaller than expected) and poor (gastric cavity was not inflated). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of lesion detection | 1 year | Gastroscope is the golden standard in diagnosing gastric diseases.we defined rate of lesion detection as the lesions detected by CE compared to gastroscope. |
Countries
China
Contacts
Primary ContactZelong Han, MD
Outcome results
None listed