Related Experiment Videos
M2A capsule endoscopy. A breakthrough diagnostic tool for small intestine imaging
1Given Imaging, Inc., 5555 Oakbrook Parkway, #355, Norcross, GA 30093, USA. marcia@givenimaging.com
Abstract:
It is estimated that 19 million people in the United States may suffer from diseases related to the small intestine, including obscure bleeding, irritable bowel syndrome, Crohns disease, chronic diarrhea, and cancer. Current diagnostic methods, including push enteroscopy and radiology, produce historically low diagnostic yield. Early studies show that the M2A Capsule Endoscope effectively visualizes the entire small bowel and demonstrates a 71% superior diagnostic yield when compared to push enteroscopy according to clinical trials reviewed by the FDA. In addition to potentially higher diagnostic yields, it provides a noninvasive diagnostic alternative where none previously existed. The M2A Capsule Endoscope received FDA clearance in August 2001 and is currently in use at major medical centers throughout the United States and Europe.
Insights
The M2A Capsule Endoscope offers a noninvasive diagnostic tool for small intestine diseases, showing a 71% higher diagnostic yield than traditional methods. This advancement improves the detection of conditions like obscure bleeding and Crohn's disease.
Area of Science:
- Gastroenterology
- Medical Devices
- Diagnostic Imaging
Background:
- 19 million Americans may have small intestine diseases.
- Current diagnostics like push enteroscopy have low diagnostic yields.
- There is a need for improved small bowel visualization.
Purpose of the Study:
- To evaluate the diagnostic yield of the M2A Capsule Endoscope.
- To compare capsule endoscopy with push enteroscopy for small bowel diseases.
Main Methods:
- Utilized the M2A Capsule Endoscope for small bowel visualization.
- Compared diagnostic yield with historical data from push enteroscopy and radiology.
- Reviewed FDA clinical trial data.
Main Results:
- The M2A Capsule Endoscope visualizes the entire small bowel.
- Demonstrated a 71% superior diagnostic yield compared to push enteroscopy.
- Received FDA clearance in August 2001.
Conclusions:
- Capsule endoscopy is a noninvasive alternative for small intestine diagnosis.
- M2A Capsule Endoscope offers higher diagnostic yield for conditions such as obscure bleeding, irritable bowel syndrome, Crohn's disease, chronic diarrhea, and cancer.
- The technology is adopted by major medical centers globally.