A multicenter study comparing the diagnosis rate between a domestic bidirectional camera and an imported Korean camera in suspected small bowel bleeding

A prospective randomized multi-center comparison study between Dual-camera MiroCam MC2000 Capsule Endoscopy and Single-camera PillCam SB3 Capsule Endoscopy in the patients with suspected small bowel bleeding: A study of Research group of capsule endoscopy and artificial intelligence in imaging

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005591

Enrollment

172

Registered

2020-11-12

Start date

2021-02-01

Completion date

Unknown

Last updated

2024-08-19

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 : (2) Capsule Endoscopy Procedure 1 Preparation before examination 1) Fasting for 8 hours before the capsule endoscope is implemented. 2) One hour before the capsule endoscopy, PEG-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: if any of the patients with suspected small intestine bleeding (1), 2 and 3)) 1) Patients who have repeated or sustained iron deficiency anemia, positive for fecal latent blood test, or actual visible bleeding have been determined to conduct capsule endoscopy during medical treatment. 2) Patients who are determined to conduct capsule endoscopy at the time of medical treatment because gastroscopy and colonoscopy did not find any obvious cause of bleeding within at least six months before the capsule endoscopy was implemented. 3) Where an adult aged 19 or older agrees to participate in this research;

Exclusion criteria

Exclusion criteria: 1) In case of hemodynamic instability 2) In the case that the previous test for the entire intestine has not been carried out due to capsule endoscopy, 3) In case of gastrointestinal paralysis, sideways, or stenosis, 4) In case of swallowing disorder 5) In the case of the Zenker Guesthouse, 6) Patients who previously had the ability to operate on small intestine resection 7) Patients with hereditary gastrointestinal polyposis 8) Patients with inflammatory growth disease 9) Patients with terminal renal failure or heart failure have difficulty taking intestinal tablets. 10) Pregnant woman 11) Patients with neuropsychiatric disorders 12) Where voluntary consent of the subject is not possible; 13) Patients with artificial heart aids (e.g., insert-type re-severter, artificial pacemaker, ventricular assist device, etc.) are not excluded at all, but are excluded when it is deemed difficult to take intestinal tablets and proceed with the examination depending on the patient's condition.

Design outcomes

Primary

Measure	Time frame
detection rate of bleeding focus based on Saurin’s classification	—

Secondary

Measure	Time frame
detection rate of ampulla of vater	—

Countries

Korea, Republic of

Contacts

Public Contacthyunju jang

Hallym University Medical Center-Dongtan

jhj1229pr@gmail.com+82-31-8086-3460

Outcome results