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Tsuboi et al. Mini-invasive Surg 2024;8:26 https://dx.doi.org/10.20517/2574-1225.2023.94 Page 13 of 21

A recent advancement in CE technology is the emergence of the smart capsule, which functions primarily as
a passive imaging tool. The smart capsule incorporates advanced technologies with diagnostic and
therapeutic functions, expanding its potential for evaluating gastrointestinal disorders.

A smart capsule capable of measuring pH, temperature, pressure, and other biochemical parameters has
been developed to assess gastrointestinal tract function. These measurements provide valuable data for
diagnosing conditions such as GERD, small intestinal bacterial overgrowth (SIBO), and motility disorders,
allowing for a more detailed understanding of the pathophysiological processes occurring within the
gastrointestinal tract.

The three smart capsules currently approved by the FDA are SmartPill® (Medtronic, Minneapolis,
MN) [166-169] , Bravo® (Medtronic, Minneapolis, MN) [170-173] , and Vibrant® (Hakochav, Yokneam, Israel) [174,175] .

SmartPill® is designed to be ingested by the patient and travels through the gastrointestinal tract, collecting
data on pH, temperature, and pressure. This device is used to evaluate gastroparesis, chronic constipation,
and whole gut dysmotility. Studies comparing SmartPill® data with gastric scintigraphy have shown a strong
correlation, with a sensitivity of 87% and specificity of 92% for detecting delayed gastric emptying in
[166]
patients with gastroparesis . Research comparing SmartPill® with radiopaque markers (ROM)
demonstrated comparable results, with a specificity of 95% for identifying slow colonic transit in
[168]
constipated patients . The capsule has shown good agreement with other diagnostic methods, with studies
reporting correlation coefficients ranging from 0.66 to 0.74 compared to ROM for whole gut transit
times .
[167]
The Bravo pH Monitoring System is a wireless, catheter-free device used for diagnosing GERD. It offers an
innovative approach to measuring esophageal pH levels over an extended period, providing more
comprehensive data compared to traditional catheter-based pH monitoring methods. Bravo has shown
higher patient tolerance and diagnostic yield due to extended monitoring. In a previous report, Sweis et al.
indicated that increased acid exposure detection rates occur when data is collected over 48 to 96 h compared
to the traditional 24-h recording period . Hasak et al. reported that prolonged wireless pH monitoring has
[173]
clinical value, showing that the acid burden from extended studies correlates with the presence and severity
[170]
of reflux symptoms when off therapy . In addition to its usefulness for pH monitoring, this modality has
good patient tolerability. Wenner et al. reported that the smart capsule caused significantly less discomfort
than catheter-based systems, contributing to improved adherence and fewer test-related activity
restrictions .
[171]

The Vibrant Capsule is a smart capsule designed for the treatment of chronic idiopathic constipation. It
represents a novel, non-pharmacological approach that uses mechanical vibrations within the
gastrointestinal tract to stimulate colonic motility and promote bowel movements. In a pivotal Phase 3,
double-blind, placebo-controlled trial involving 312 patients, the Vibrant Capsule significantly increased the
number of complete spontaneous bowel movements (CSBMs) compared to placebo (39.3% vs. 22.1%, P =
0.001). Improvements were observed as early as the second week of treatment and were sustained
throughout the trial period .
[175]
Smart capsules currently under investigation include the intestinal fluid sampling capsule (Capscan®,
Envivo, California, USA) [176,177] , the Smart Capsule Bacterial Detection System (Biora Therapeutics, San
[179]
Diego, CA) , and the gas sensing capsule device (ATMO Biosciences, Australia, USA) . A new vibrating
[178]
capsule, Vibrabot (AnX Robotica, Texas, USA) , is also under development. Additionally, the NaviCap
[180]