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

NCT02886338 | Completed Results

• 1 other identifier: 201505067
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Patient on Good Condition

Outcome Measures

Primary Outcomes (1)

• 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)

  The outcome measure was performed within 2 weeks after examination

Study Arms (1)

capsule endoscopy examination

EXPERIMENTAL

Capsule endoscopic examination for the esophagus, stomach and duodenum.

Device: capsule endoscopy

Interventions

capsule endoscopy DEVICE

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.

capsule endoscopy examination

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 20-65 adults had experience on insudative upper endoscopy without any contraindication.

You may not qualify if:

• Patient with obstruction of gastrointestinal tract.
• Pregnant woman.
• Patient implantation of pacemaker.
• Patient implanted with metal electronic devices、artificial joints or fixator.
• Patient with cancer.
• Patient with difficulty in swallowing.
• Patient with operation on the stomach.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Capsule Endoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Fat-Moon, Suk
• Organization: TMU

fmsuk@tmu.edu.tw

29307930

Study Officials

• Fat Moon Suk

  Taipei Medical University WanFang Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: September 1, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 15, 2018
• Results First Posted: August 4, 2017

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)