A prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter for the treatment of Gastroesophageal Reflux Disease (GERD).

GERD is a chronic disorder associated with substantial morbidity and a major
adverse impact on patient quality lof life. In industrialized nations the
disease has become increasingly commonwith an estimated prevalence in the
general population of approximately 7%.
The normal physiological barrier to GERD is made up of two major components:
The LES and the diaphragm. A sphincter muscle provides tone to create a high
pressure zone. The LES muscle works in conjunction with the diaphragm to close
the junction between the esophagus and the stomach keeping acidic contents from
refluxing into the esophagus. A competent LES keeps the esophagus closed to
gastric contents and opens during swallowing to allow food to pass into the
stomach. An incompetent LES, however, will open from normal gastric pressures
and allow acidic contents to reflux into the esophagus. An incompetent LES is
the result of a weak muscle that does not have enough tone to keep the
esophagus closed.
Torax Medical, Inc. has designed a device to augment the LES. The device is
designed to be placed on the external esophagus in the region of the (LES).
The implant is comprised of a circumferential series of magnetic beads, where
the attractive force of the magnetic beads provides additional strength to
close a weak LES under normal gastric pressure.

This study is conducted to evaluate a novel method of augmenting a weak Lower
Esophageal Sphincter (LES) with a magnetic esophgeal sphincter device.

This study is a prospective, non-randomized, open label, five center registry
with up to fifty (50) patients receiving the Magnetic Esophageal Sphincter.
Data collected during this study include, but may not be limited to, the
following:
• Proton Pump Inhibitor (PPI), H2, and/or antacid use,
• 24hr pH assessment,
• LES manometry,
• Quality of Life Scores,
• Endoscopy,
• X-ray,
• Fluoroscopy (Barium Esophagram),
• Adverse Events.
Patients will be followed for twelve months to evaluate effectiveness of the
treatment and any adverse events.
Till now 3 center are gonna participate in this trial with addition to 5
center.

The participating subjects will get the following tests in the screening period:
Endoscopy
24hr pH assesment
LES manometry
Fluoroscopy (barium esophgram)

All enrolled patients will receive the magnetic Esophageal Sphincter device.
This procedure will be performed in the OLVG hospital in Amsterdam.

Patienst will be followed for 12 months to evaluate effectiveness of the
treatment and any adverse events.
6 months after treatment the following tests will be perforemd:
Endoscopy
LES manometry and 24hr pH assesment
Abdominal/chest x-ray

12 months after treatment a barium esophagram and an abdominal/chest x-ray will
be performed.

In the screening period the patient will visit the AMC hospital 3x for the
following tests:.
LES manometry and 24hr pH assesment. For this tests the patient should be off
PPI treatment for 5 days and should remain fasted from midnight the day before.
Endoscopy. He should remain fasted from midnight the day before.
Barium Esophagram. Remain fasted from 4 hours.

The implant procedure will be perofrmed in the OLVG hospital. The patient
should remain fasted from midnight the day before. An abdominal/chest x-ray
will be performed. Expected hospitalization will be 2 days. You could find
the potential risks in the ABR form section E9. The potential benefits are
described in section E9a.

Patienst will be followed for 12 months to evaluate effectiveness of the
treatment and any adverse events.
6 months after treatment the following tests will be perforemd:
Endoscopy
LES manometry and 24hr pH assesment
Abdominal/chest x-ray
The same preparations as described in the screening period are required.

12 months after treatment a barium esophagram and an abdominal/chest x-ray will
be performed.
The same preparations as described in the screening period are required.