A Novel External Lead Sensor Array Placement Approach for Capsule Endoscopy

Abstract

A Novel External Lead Sensor Array Placement Approach for Capsule Endoscopy Gary Chen, Oren Goltzer, Jason Shen, Christopher Chang, Shahab Mehdizadeh, James Sul, Rome Jutabha Background: Capsule endoscopy (CE) of the small bowel (SB) & esophagus (ESO) requires placement of 8 lead sensor array over the abdomen that receives image and localization data transmitted from the capsule. This current process of applying lead sensor array to the skin has disadvantages: 1) it is time consuming, and 2) it can be uncomfortable to the patient. We hypothesized that a new external sensor array system could adequately receive transmitted images during CE without significant data loss and have equivalent diagnostic yield with standard skin leads. Methods: We tested this new device on 13 patients from 8/2005-11/2005. 8 patients underwent esophageal CE for GERD and 5 had small bowel CE for OGIB. All 13 patients had 2 sets of sensor arrays, batteries, and data recorders placed concurrently. The standard array was placed on the skin surface of the chest or abdomen in the usual manner (control) while the external array was pre-positioned on a gown that was worn over the skin leads. The total number of captured versus dropped images recorded by the skin and external lead systems were compared visually and then analyzed statistically. Results: 8/8 GERD patients had grade 1-2 reflux esophagitis on CE ESO. 4/5 OGIB patients had small bowel AVM’s while 1 patient had a small bowel carcinoid tumor on CE SB. The same final diagnoses were made on all 13 patients by both standard and novel external lead methods. For the 13 patients, a total of 313793 images were detected on CE procedures with the standard method while 311169 images were detected with the novel external method (99.2% of the control). All of the non-captured images missed by the external array leads occurred in short segments (4-5 frame segments); no prolonged stretches of missing data occurred with either method. The quality of captured CE images was identical between the 2 methods, but CE localization tracings were different, presumably related to movement of the leads during the recording period. Most of the patients preferred the novel external method because of less skin irritation and discomfort during the lead removal process, as well as shorter setup time without the need of removing clothing. Conclusion: 1) A pre-positioned external lead sensor array can achieve CE data without clinically significant loss of image quality and diagnostic yield, 2) localization tracings for CE SB are different due to movement of the external array, 3) more patients preferred the novel external method than the standard method. These preliminary results must be confirmed with larger sample size.