Healthy Patient on Good Condition
Conditions
Brief summary
External control of capsule endoscopy (CE) by means of an applied magnetic field is a possible way to maneuver the movement of CE in gastrointestinal (GI) tract. The aim of this study was to evaluate the safety and feasibility of magnetic maneuvering of a capsule endoscope in the upper gastrointestinal tract, including the esophagus, stomach and duodenum in healthy subjects.
Detailed description
Since their introduction in clinical practice in 2000, capsule endoscopy (CE) have widely used as a noninvasive endoscopic examination of the gastrointestinal disorders. Compared with traditional endoscopy, CE has had a significant impact in gastroenterology for diagnoses of gastrointestinal (GI) diseases, largely owing to the following three reasons. First, wireless CE is much more comfortable for the patient. Second, it is much easier and safer to perform. Third, it allows visualization of anatomical regions currently precluded to traditional endoscopy. However, CE does not allow the operator to control the navigation. The movement of the capsule is passive, as it proceeds by means of visceral peristalsis and gravity. This makes the movement of the capsule purely random, so that some portions of the gastrointestinal surface are unable to be visualized. Moreover, if gastrointestinal lesions are identified, the endoscopist cannot maneuver the capsule to perform back and forth, or right and left movement to do further detailed observations. All of these factors contribute to limit the diagnostic values of CE examination. External controllability of CE by means of an applied magnetic field is a possible solution to the maneuvering problem. However, there is no effective system with straightforward clinical applicability till now. This is ascribable to a lack of reliable magnetic instrumentation suitable for such a purpose. We have reported that using magnetic field navigator can effectively control the locomotion of CE. We have demonstrated, both in vitro and ex vivo, that magnetic field navigator has great potential and practicability of achieving high-precision rotation and controllable movement of CE. The aim of this study was to evaluate the safety and feasibility of magnetic maneuvering of a capsule endoscope in the upper gastrointestinal tract, including the esophagus, stomach and duodenum in healthy subjects. The movement of the endoscopic capsule in the esophagus could be driven by an external magnetic control device. The external magnetic control device could also adjust the direction of movement of the capsule in the stomach and duodenum, which might make the examination of the whole upper gastrointestinal tract possible. The magnetic navigated CE would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract.
Interventions
DEVICEcapsule endoscopy
The magnetic navigated CE would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract.
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 20-65 adults had experience on insudative upper endoscopy without any contraindication.
Exclusion criteria
1. Patient with obstruction of gastrointestinal tract. 2. Pregnant woman. 3. Patient implantation of pacemaker. 4. Patient implanted with metal electronic devices、artificial joints or fixator. 5. Patient with cancer. 6. Patient with difficulty in swallowing. 7. Patient with operation on the stomach.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Completeness of Capsule Endoscopy | The outcome measure was performed within 2 weeks after examination | Evaluate the completeness of capsule endoscopic examination. Visualization of the mucosa of esophagus, stomach and duodenum is analyzed separately during and after the capsule endoscopic examination by real time image and capsule video images. We evaluate the percentage of mucosa that can be clearly examined with a 5-point assessment scale (0%, 25%, 50%, 75% and 100% of the visibility of the mucosa of esophagus, stomach, and duodenum) |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capsule Endoscopy Group Capsule endoscopy group: Participants swallowed a magnetic-assisted capsule endoscope, and an external magnetic field navigator is used for magnetic capsule manipulation in the upper gastrointestinal tract.
The movement of the magnetic capsule endoscope can be driven by an external magnetic field navigator. The external magnetic field navigator can also adjust the direction of movement of the capsule in the stomach and duodenum. Through the external magnetic-mediated navigation of the capsule in the upper gastrointestinal tract, clinicians can potentially examine the whole upper gastrointestinal tract. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Capsule Endoscopy Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Region of Enrollment Taiwan | 9 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Assess the Completeness of Capsule Endoscopy
Evaluate the completeness of capsule endoscopic examination. Visualization of the mucosa of esophagus, stomach and duodenum is analyzed separately during and after the capsule endoscopic examination by real time image and capsule video images. We evaluate the percentage of mucosa that can be clearly examined with a 5-point assessment scale (0%, 25%, 50%, 75% and 100% of the visibility of the mucosa of esophagus, stomach, and duodenum)
Time frame: The outcome measure was performed within 2 weeks after examination
Population: Subjects had completed the magnetic capsule endoscopic examination
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Capsule Endoscopy Group | Assess the Completeness of Capsule Endoscopy | Percentage of visibility of Mucosa : esophagus | 100 percentage of mucosa visibility |
| Capsule Endoscopy Group | Assess the Completeness of Capsule Endoscopy | Percentage of visibility of Mucosa: stomach | 85.2 percentage of mucosa visibility |
| Capsule Endoscopy Group | Assess the Completeness of Capsule Endoscopy | Percentage of visibility of Mucosa: duodenum | 86.1 percentage of mucosa visibility |