Trial Outcomes & Findings for Study of the Feasibility of Magnetic Navigated Capsule Endoscope in the Upper Gastrointestinal Tract Examination (NCT NCT02886338)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

The outcome measure was performed within 2 weeks after examination

Results posted on

2018-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Capsule Endoscopy Group 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. capsule endoscopy: The magnetic navigated capsule endoscope 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.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Capsule Endoscopy Group 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. capsule endoscopy: The magnetic navigated capsule endoscope 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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study of the Feasibility of Magnetic Navigated Capsule Endoscope in the Upper Gastrointestinal Tract Examination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capsule Endoscopy Group n=9 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Taiwan	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: The outcome measure was performed within 2 weeks after examination

Population: Subjects had completed the magnetic capsule endoscopic 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)

Outcome measures

Outcome measures
Measure	Capsule Endoscopy Group n=9 Participants 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.
Assess the Completeness of Capsule Endoscopy Percentage of visibility of Mucosa : esophagus	100 percentage of mucosa visibility Interval 100.0 to 100.0
Assess the Completeness of Capsule Endoscopy Percentage of visibility of Mucosa: stomach	85.2 percentage of mucosa visibility Interval 61.1 to 100.0
Assess the Completeness of Capsule Endoscopy Percentage of visibility of Mucosa: duodenum	86.1 percentage of mucosa visibility Interval 83.9 to 88.9

Adverse Events

Healthy Subjects With Capsule Endoscopy Examination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fat-Moon, Suk

TMU

Phone: 29307930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place