A Confirmatory Clinical Study to Evaluate the Efficacy and Safety of 3 Dimension Wireless Magnetically Assisted Capsule Endoscopy

Prospective, Single-center, 2-Sequence Examination (Not-Randomization), Self-control, Active-controlled Design, Pivotal Study to Evaluate the Efficacy and Safety of 3 Dimension Wireless Magnetically Assisted Capsule Endoscopy (IntroMedic MC4000-M) as Compared to Wire Upper Endoscopy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0007114

Enrollment

Registered

2022-03-25

Start date

2022-04-12

Completion date

Unknown

Last updated

2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Subjects will be assigned and treated with test device, the 3-dimension wireless magnetically assisted capsule endoscopy (IntroMedic MC4000-M) and then with control device, the conven

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 2. Subject who can understand and follow the instruction and can participate the entire clinical trial period 3. Subject who voluntarily decided to participate in this clinical trial and gave written consent to the subject consent form

Exclusion criteria

Exclusion criteria: 1. Subject with swallowing difficulties 2. Subject who has difficulty taking bowel cleansing agent 3. Digestive tract perforation, bleeding or blockage 4. Surgery of digestive system 5. Current history of cardiovascular, digestive, respiratory, endocrine, or CNS system with clinically significant impairment or mental illness 6. Disorders of bowel movement and/or marked delay or significant disturbance of gastrointestinal motility 7. Prohibited concomitant medications and/or treatments 8. Devices that generate or interfere with magnetic fields, such as pacemakers, defibrillators, cerebral aneurysm clips, artificial ears, or nerve stimulators 9. Participation in other clinical trial within 30 days prior to screening visit 10. Woman of childbearing potential who does not consent to medically adequate contraception 11. Pregnant or lactating women 12. Other clinical findings that are considered inappropriate for this study in the judgment of investigator

Design outcomes

Primary

Measure	Time frame
anatomical structures in upper GI (assessed by Independent Central Reviewer)	—

Secondary

Measure	Time frame
Rate of diagnostic agreement between ICR and Investigator ;Physican's global satisfaction rate ;Patient's global satisfaction rate ;additional usefulness of test device as small bowel endoscopy ;3D image analysis upon clinically significant lesions ;Adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactJinyoung Lee

IntroMedic

jylee@intromedic.com+82-2-801-9386

Outcome results