Abstract：
BACKGROUND: Evaluation of gut motility in clinical practice is currently limited. A novel medical system (MoPill™) consisting of a capsule that wirelessly transmits radiofrequency signals to assess motility via 3D location, was used to conduct this study. The objectives were to: (1) confirm the safety of the MoPill™ system; (2) compare the 3D location transmitted by the capsule to its location captured by abdominal x-rays; 3 determine gastric emptying (GE), whole gut transit time (WGTT) and segmental transit times.
METHODS: The MoPill™ system consists of an electronic capsule (2 × 1.2 cm), eight color-coded adhesive sensors (6 × 5.5 cm), a recorder (15 × 11 × 2 cm), and software on a laptop. Four sensors were applied to the abdomen and four to the back. Healthy subjects who had fasted overnight ingested a 250-calorie protein bar, 17 oz. of water, followed by an activated capsule. No further caloric contents were permitted for the next 5 h. At 1, 5, and 24 h (if the capsule had not been expelled), upright abdominal X-rays (AP and lateral) were obtained to assess the location of the capsule, which was compared to the gastrointestinal positioning system (GPS) location determined by the MoPill™ system. Identification of the capsule\'s anatomical location by the MoPill™ system was based on (1) the 3D (x, y, z) location; (2) time; (3) trajectory (e.g., going up the right side of the body signified ascending colon); (4) frequency of contractions (e.g., 3 cycles/min for the stomach); and (5) milestone relationship (e.g., pyloric passage must follow the end of gastric contractions). GE was determined first by the end of the 3 cycles/min rhythmic movement of the stomach and then again by pyloric expulsion on 3D location. Small intestine transit was taken as the duration from pyloric expulsion to arrival in the cecum. Colon transit time was determined by calculating the duration from 3D arrival in the cecum to passage of the capsule out of the body (i.e., loss of signal accompanying a bowel movement).
RESULTS: Ten healthy subjects (five women; mean age 34; mean BMI 24) were enrolled, and nine provided reliable data. The variation between the x-ray and the estimated (i.e., identified by the MoPill™ system) location of the capsule was within an average of 3.5 cm (range 0.9-9.4 cm). The mean GE was 3.1 h. The small intestine\'s mean transit time was 4.3 h. The mean colonic transit time was 17.6 h. There were no adverse events recorded during the study.
CONCLUSIONS: MoPill™ is a novel gastrointestinal positional system that accurately identifies the location of a capsule compared to an X-ray. MoPill™ system also recognizes GE, small bowel, colonic, and WGTT as well as segmental gut location and movement characteristics. MoPill™ offers the potential for new insights into GI motility disorders not attainable by current modalities.
METHODS: The MoPill™ system consists of an electronic capsule (2 × 1.2 cm), eight color-coded adhesive sensors (6 × 5.5 cm), a recorder (15 × 11 × 2 cm), and software on a laptop. Four sensors were applied to the abdomen and four to the back. Healthy subjects who had fasted overnight ingested a 250-calorie protein bar, 17 oz. of water, followed by an activated capsule. No further caloric contents were permitted for the next 5 h. At 1, 5, and 24 h (if the capsule had not been expelled), upright abdominal X-rays (AP and lateral) were obtained to assess the location of the capsule, which was compared to the gastrointestinal positioning system (GPS) location determined by the MoPill™ system. Identification of the capsule\'s anatomical location by the MoPill™ system was based on (1) the 3D (x, y, z) location; (2) time; (3) trajectory (e.g., going up the right side of the body signified ascending colon); (4) frequency of contractions (e.g., 3 cycles/min for the stomach); and (5) milestone relationship (e.g., pyloric passage must follow the end of gastric contractions). GE was determined first by the end of the 3 cycles/min rhythmic movement of the stomach and then again by pyloric expulsion on 3D location. Small intestine transit was taken as the duration from pyloric expulsion to arrival in the cecum. Colon transit time was determined by calculating the duration from 3D arrival in the cecum to passage of the capsule out of the body (i.e., loss of signal accompanying a bowel movement).
RESULTS: Ten healthy subjects (five women; mean age 34; mean BMI 24) were enrolled, and nine provided reliable data. The variation between the x-ray and the estimated (i.e., identified by the MoPill™ system) location of the capsule was within an average of 3.5 cm (range 0.9-9.4 cm). The mean GE was 3.1 h. The small intestine\'s mean transit time was 4.3 h. The mean colonic transit time was 17.6 h. There were no adverse events recorded during the study.
CONCLUSIONS: MoPill™ is a novel gastrointestinal positional system that accurately identifies the location of a capsule compared to an X-ray. MoPill™ system also recognizes GE, small bowel, colonic, and WGTT as well as segmental gut location and movement characteristics. MoPill™ offers the potential for new insights into GI motility disorders not attainable by current modalities.
摘要：
背景：在临床实践中对肠道运动的评估目前是有限的。一种新颖的医疗系统（MoPill™），由无线传输射频信号以通过3D定位评估运动性的胶囊组成，被用来进行这项研究。目的是：（1）确认MoPill™系统的安全性；（2）将胶囊传输的3D位置与腹部X射线捕获的位置进行比较；3确定胃排空（GE），整个肠道运输时间（WGTT）和分段运输时间。
方法：MoPill™系统由电子胶囊（2×1.2厘米）组成，八个颜色编码的粘合剂传感器（6×5.5厘米），录音机(15×11×2厘米),和笔记本电脑上的软件。四个传感器应用于腹部，四个传感器应用于背部。禁食过夜的健康受试者摄入了250卡路里的蛋白质棒，17盎司。水，接着是一个激活的胶囊。在接下来的5小时内，不允许进一步的热量含量。在1、5和24小时（如果胶囊未排出），获得直立的腹部X射线（AP和侧面）以评估胶囊的位置，将其与由MoPill™系统确定的胃肠定位系统(GPS)位置进行比较。MoPill™系统对胶囊解剖位置的识别基于(1)3D(x，y,z)位置；(2)时间；(3)轨迹(例如，身体右侧上升表示升结肠)；(4)收缩频率(例如，胃3个周期/分钟)；和(5)里程碑关系(例如，幽门通道必须在胃收缩结束后）。首先在胃的3个周期/分钟的节律运动结束时确定GE，然后在3D位置上再次通过幽门排出来确定GE。小肠转运是从幽门排出到到达盲肠的持续时间。通过计算从3D到达盲肠到胶囊离开身体的持续时间来确定结肠运输时间（即，伴随排便的信号丢失)。
结果：纳入了10名健康受试者（5名女性；平均年龄34岁；平均BMI为24），9人提供了可靠的数据。x射线和估计的(即，由MoPill™系统确定）胶囊的位置在平均3.5cm（范围0.9-9.4cm）内。平均GE为3.1h。小肠的平均运输时间为4.3h。平均结肠运输时间为17.6h。在研究期间没有记录到不良事件。
结论：MoPill™是一种新型的胃肠道位置系统，与X射线相比，可以准确识别胶囊的位置。MoPill™系统还可识别GE,小肠,结肠,和WGTT以及节段肠道位置和运动特征。MoPill™提供了对当前模式无法实现的胃肠道运动障碍的新见解的潜力。
方法：MoPill™系统由电子胶囊（2×1.2厘米）组成，八个颜色编码的粘合剂传感器（6×5.5厘米），录音机(15×11×2厘米),和笔记本电脑上的软件。四个传感器应用于腹部，四个传感器应用于背部。禁食过夜的健康受试者摄入了250卡路里的蛋白质棒，17盎司。水，接着是一个激活的胶囊。在接下来的5小时内，不允许进一步的热量含量。在1、5和24小时（如果胶囊未排出），获得直立的腹部X射线（AP和侧面）以评估胶囊的位置，将其与由MoPill™系统确定的胃肠定位系统(GPS)位置进行比较。MoPill™系统对胶囊解剖位置的识别基于(1)3D(x，y,z)位置；(2)时间；(3)轨迹(例如，身体右侧上升表示升结肠)；(4)收缩频率(例如，胃3个周期/分钟)；和(5)里程碑关系(例如，幽门通道必须在胃收缩结束后）。首先在胃的3个周期/分钟的节律运动结束时确定GE，然后在3D位置上再次通过幽门排出来确定GE。小肠转运是从幽门排出到到达盲肠的持续时间。通过计算从3D到达盲肠到胶囊离开身体的持续时间来确定结肠运输时间（即，伴随排便的信号丢失)。
结果：纳入了10名健康受试者（5名女性；平均年龄34岁；平均BMI为24），9人提供了可靠的数据。x射线和估计的(即，由MoPill™系统确定）胶囊的位置在平均3.5cm（范围0.9-9.4cm）内。平均GE为3.1h。小肠的平均运输时间为4.3h。平均结肠运输时间为17.6h。在研究期间没有记录到不良事件。
结论：MoPill™是一种新型的胃肠道位置系统，与X射线相比，可以准确识别胶囊的位置。MoPill™系统还可识别GE,小肠,结肠,和WGTT以及节段肠道位置和运动特征。MoPill™提供了对当前模式无法实现的胃肠道运动障碍的新见解的潜力。
