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
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 165
研究概览
简要总结
Results: Data from 151 of 165 enrolled patients were analyzed. fourteen patients were excluded for technical reason or withdrawal of informed consent. AoV was detected in 32 patients (21%) with MC2000 and 27 patients (17.9 %) with PC3, respectively. Lesions detected at VCE was classified as the Saurin classification (P0, P1, P2 lesions).P1 lesions were identified in 71 patients (47%) with MC2000 and 65 patients (43%) with PC3, respectively. P2 lesions were identified in 43 patients (28.5%) with MC2000 and 39 patients (25.8%) with PC3, respectively. Red spots, angioectasias and diverticulum were more frequently detected at MC 2000 than at PC3 (32% vs 26.5%, 14.6% vs 10.6% and 4% vs 2%). Conclusion: This study shows that MC2000 with dual camera appears to increase the detection rate of SB
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •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;
排除标准
- •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.