A Pilot Study of Cryotherapy for Barrett's Esophagus With High-Grade Dysplasia and Early Esophageal Cancers
The Cryo-Ablator System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter
and accessories to destroy tissue during surgical procedures by applying extreme cold.
Patients will prepare for esophagogastroduodenoscopy (EGD) in the standard fashion using an
overnight fast with only clear liquids and required medications allowed up to 2 hours before
the procedure. The EGD will be performed using a therapeutic Olympus endoscope. The
cryocatheter is passed into the therapeutic channel of the endoscope. Liquid nitrogen is
sprayed through the cryocatheter for a duration of 10 seconds as measured by the device
integrated timer. This process will be repeated four times in piecemeal fashion such that
for any given area treated it will be maintained in a frozen state for a total of 40
seconds. Following circumferential treatment, the process will be repeated again applying
the spray to the same section of mucosa for a duration of 20 seconds. Patients will be
contacted the following day to assess for any immediate complications.
Patients will repeat treatment every 6 weeks if no evidence of esophageal mucosal injury,
until complete ablation of the Barrett's mucosa has been achieved. Follow up period of five
years to monitor healing and progression.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients that achieved successful ablation of dysplasia and neoplasia Barrett's Esophagus.
Determined by the end of protocol biopsies: incremental (absence of HGD and IMCA in all specimens); partial (residual IMCA with absence of any dysplasia); complete (absence of any intestinal metaplasia or dysplasia)
at 12 months from start of treatment
John A. Dumot, D.O.
The Cleveland Clinic
United States: Food and Drug Administration
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