Technical feasibility of the EsoFLIP Achalasia Dilation Balloon

Achalasia is treated with medication, injection of botulism toxin, surgically
by Heller myotomy or endoscopically by either *per-oral endoscopic
myotomy* (POEM) or pneumatic balloon dilation. In the latter case, a balloon is
inserted into the esophagus and dilated to a pressure of approximately 1.5 atm.
Therapeutic success is approximately 90% for standard balloon dilation. Most
balloons are calibrated to achieve a target diameter for a given balloon
pressure in free air. It is however not necessarily the case that in-vivo the
target diameter is achieved due to resistance/recoil from the esophagus.
Fluoroscopy is often used to assess the lumen diameter post-dilation. This
exposes the patient to radiation and does not give an actual lumen measurement
(unless a prior calibration procedure is performed). With a new dilation
catheter, the EsoFLIP, it is possible to measure the balloon diameter
electronically during dilation. The EsoFLIP uses a commercially available
impedance measurement technique with a series of measuring electrodes located
within the dilation balloon. The balloon itself is a standard dilation balloon.
With this technique, a digital image can be shown on a computer monitor, which
accurately shows the shape of the balloon at that time. This obviates the need
for radiation exposure, since fluoroscopy will not be needed anymore.

The objective of this study is to assess the technical feasibility of the
EsoFLIP dilation balloon in the treatment of achalasia

Single arm prospective study with no comparator group. All patients will
receive balloon dilation treatment according to standard clinical practice
using a 30 mm EsoFLIP balloon. Two days later, treatment will be repeated using
the 30mm catheter. Patients will be followed up afterwards for three months.

Dilation of the LES using the EsoFLIP catheter.

Since pneumatic dilation is a well-established and well tested method for
treating achalasia, it is well-known that there are certain risks to this
treatment. The most important complications are perforation of the esophagus, a
bleed in the esophagus, pain and the risk of developing gastro esophageal
reflux disease. Since dilation with the EsoFLIP is comparable to standard
dilation, we expect that the number and severity of complications will be
either comparable or lower. Since this balloon gives feedback about its shape,
it might be easier to estimate when the treatment is successful. Because of
this, it is expected that there will be a reduction in the number of
complications.