Backgrounds and Aims Complete and consecutive observation of the gastrointestinal (GI) tract continues to present challenges for current endoscopy systems. We developed a novel upper and mid gastrointestinal (UMGI) capsule endoscopy using the modified detachable string magnetically controlled capsule endoscopy (DS-MCE) and inspection method and aimed to assess the clinical application. Methods Patients were recruited to undergo UMGI capsule endoscopy followed by esophagogastroduodenoscopy. All capsule procedures in the upper gastrointestinal (UGI) tract were conducted under the control of magnet and string. The main outcome was technical success, and the secondary outcomes included visualization of the UMGI tract, examination time, diagnostic yield, compliance, and safety evaluation. Results Thirty patients were enrolled and all UMGI capsule procedures realized repeated observation of the esophagus and duodenum with detection rates of 100.0%, 80.0%, and 86.7% of Z-line, duodenal papilla, and reverse side of pylorus, respectively. String detachment was succeeded in 29 patients (96.7%) and the complete examination rate of UMGI tract was 95.45% (21/22). All UMGI capsule procedures were well tolerated with low discomfort score, and had a good diagnostic yield with per-lesion sensitivity of 96.2% in UGI diseases. No adverse events occurred. Conclusions This new capsule endoscopy system provides an alternative screening modality for the UMGI tract, and might be indicated in cases of suspected upper and small bowel GI bleeding. Trial registration DS-MCE-UGI and SB, NCT04329468. Registered 27 March 2020, https://clinicaltrials.gov/ct2/results?cond=&term=NCT04329468.

Background Certain patients experience difficulty swallowing a video capsule endoscopy (VCE) device owing to its relatively large size. The newly developed small-sized magnetically controlled capsule endoscopy (MCE) device is the smallest VCE device ever reported. We aimed to evaluate the performance of the small-sized MCE device in terms of ingestion and examination efficacy. Methods Patients in two centers were prospectively enrolled and randomized to the small-sized or standard MCE groups. Differences in capsule ingestion difficulties, visualization of the gastrointestinal tract, and capsule transit times were compared. Results 96 patients were enrolled (48 in each group). In the small-sized MCE group, the mean (SD) difficulty score and time to swallow the capsule, and success rate for swallowing the capsule at the first attempt were 0.6 (1.0), 3.4 (1.3) seconds, and 89.6 %, which was significant better compared with the standard MCE group with 3.1 (1.7), 12.0 (14.3) seconds and 60.4 %, respectively (all P < 0.001). Visualization of the esophagus, stomach, and small bowel were comparable between the two groups. The small-sized MCE group had a significantly shorter gastric transit time (49.4 minutes vs. 66.2 minutes; P = 0.04) and longer small-bowel transit time (5.8 hours vs. 5.0 hours; P = 0.045). Conclusions The small-sized MCE device is feasible and safe for gastrointestinal examination, alleviating difficulties in capsule ingestion, improving gastric emptying under magnetic control, and prolonging the small-bowel transit time.

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