Kuo Braden, Lee Allen A, Abell Thomas, Attaluri Ashok, Cline Michael, Hasler William, Ho Vincent, Lembo Anthony J, Masoud Amir, McCallum Richard, Moshiree Baharak, Quigley Eamonn M M, Rao Satish S C, Stocker Abigail, Sanchez Mayra, Sarosiek Irene, Surjanhata Brian, Zhou Jerry, Chey William D
Center for Neurointestinal Health, Gastroenterology Unit, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan.
Clin Gastroenterol Hepatol. 2025 Aug;23(9):1633-1641.e8. doi: 10.1016/j.cgh.2024.12.013. Epub 2025 Jan 30.
BACKGROUND & AIMS: Wireless motility capsules (WMCs) can be used to assess gastrointestinal transit time to facilitate diagnosis and treatment of motility disorders. The Atmo Capsule is a novel WMC that measures gases (H, CO, O) and temperature. We aimed to compare and evaluate the performance characteristics of the Atmo Capsule and the SmartPill Capsule (discontinued reference standard WMC) for measurement of gastric emptying time (GET) and colonic transit time (CTT) in patients with confirmed or suspected disordered gastrointestinal transit.
Patients with symptoms indicative of an upper and/or lower gastrointestinal motility disorder ingested the 2 WMCs in a random order. Gastrointestinal transit times were assessed using Spearman correlation and Bland-Altman analysis. Device agreement was assessed for delayed GET (≥5 hours) and CTT (≥59 hours).
There were 213 participants from 12 sites, yielding 177 paired GET and 147 paired CTT measurements. The measurements for GET and CTT with the Atmo Capsule and SmartPill Capsule were strongly correlated (GET, R = 0.74, P < .01; CTT, R = 0.69, P < .01), and their observed biases were within 10% of the delayed transit margin. Both delayed GET (68/177) and CTT (56/147) were identified in 38% of participants, with 84% agreement for identification of both delayed GET (sensitivity 68%, specificity 91%) and CTT (sensitivity 83%, specificity 85%). No serious adverse device effects were reported.
The performance characteristics of the Atmo Capsule for measurements of GET and CTT were equivalent to the reference standard WMC with a strong correlation and good device agreement. These results demonstrate that the Atmo Capsule is a valid method for evaluating gastrointestinal transit.
gov number, NCT05718505.
无线动力胶囊（WMCs）可用于评估胃肠传输时间，以促进动力障碍的诊断和治疗。Atmo胶囊是一种新型的WMC，可测量气体（H、CO、O）和温度。我们旨在比较和评估Atmo胶囊与SmartPill胶囊（已停产的参考标准WMC）在确诊或疑似胃肠传输紊乱患者中测量胃排空时间（GET）和结肠传输时间（CTT）的性能特征。
有上消化道和/或下消化道动力障碍症状的患者随机摄入两种WMC。使用Spearman相关性分析和Bland-Altman分析评估胃肠传输时间。评估设备在延迟GET（≥5小时）和CTT（≥59小时）方面的一致性。
来自12个地点的213名参与者，获得177对GET测量值和147对CTT测量值。Atmo胶囊和SmartPill胶囊对GET和CTT的测量结果高度相关（GET，R = 0.74，P <.01；CTT，R = 0.69，P <.01），且观察到的偏差在延迟传输界限的10%以内。38%的参与者同时出现延迟GET（68/177）和CTT（56/147），在延迟GET（敏感性68%，特异性91%）和CTT（敏感性83%，特异性85%）的识别上有84%的一致性。未报告严重的设备不良影响。
Atmo胶囊在测量GET和CTT方面的性能特征与参考标准WMC相当，具有高度相关性和良好的设备一致性。这些结果表明Atmo胶囊是评估胃肠传输的有效方法。
gov编号，NCT05718505。
