IRB Number:

08-006049

Trial Status:

Inactive

Phase: II

Why is this study being done?

In patients with gastroesophageal reflux disease, the natural barrier has lost the muscular tone necessary to keep the contents of the stomach from routinely "refluxing" into the esophagus.

This reflux is responsible for the discomfort of heartburn. More importantly, it can damage the walls of the esophagus and lead to more serious conditions such as esophagitis and Barrett's esophagus.

The LINX System is an investigational device designed to restore the function of the lower esophageal sphincter; preventing reflux and many of the symptoms that accompany it.

The LINX device is made of titanium beads that are linked together to take the shape of a small bracelet. Each of these beads contains a magnetic core that attracts it to the beads next to it.

Using a surgical technique called laparoscopy, the device is placed around the esophagus in the area of the lower esophageal sphincter. Once in place, the magnetic attraction between the beads may help support the esophagus to prevent reflux.

Minimum Age:

18

Maximum Age:

75

What is Involved With this Study?

Screening procedures which include and are standard of care:
- Office visit
- Health history
- Questionnaires relating to health
- Esophageal pH testing
- Manometry testing
- EGD endoscopy
- Barium esophagram

Surgery:
- Implanting of Linx device

Follow-up at the following intervals and paid for by the study:
Discharge:
- Chest X-ray

3 Months post-implant:
- Questionnaires

6 Months post-implant:
- Office visit
- Questionnaires

12 Months post-implant:
- Office visit
- Health history
- Questionnaires
- Esophageal pH
- Manometry testing
- EGD endoscopy
- Barium esophagram
- Chest X-ray

How long will the Study run?

1 Year

Study Coordinator:
Barbara G. Berg, C.C.R.P.
berg.barbara2@mayo.edu
3-7988

Who can I Contact for Additional Information on this Trial?

Barbara G. Berg, C.C.R.P.
Clinical Studies Unit
Phone: 904-953-2854

What is/are the Locations of this Clinical Trial?

• Jacksonville, FL

Last updated: 10/01/2009