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A Pilot Study of Cryotherapy for Barrett's Esophagus With High-Grade Dysplasia and Early Esophageal Cancers

Phase 0
18 Years
Not Enrolling
Barretts Esophagus, Esophageal Cancer

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Trial Information

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.

Inclusion Criteria:

Group 1:

- Co-morbid conditions such as severe heart, lung, kidney or liver disease.

- Refusal of surgical intervention after a thorough discussion of the highly
experimental nature of cryotherapy.

Group 2:

- Patients with inoperable esophageal cancer (adenocarcinoma oe squamous cell CA) with
lesions extending beyond the mucosa but limited to the esophageal wall

Exclusion Criteria:

- Age less than 18 years

- Co-morbid illness expected to cause death within 6 months

- Pregnancy

- Refusal or inability to give consent

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients that achieved successful ablation of dysplasia and neoplasia Barrett's Esophagus.

Outcome Description:

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)

Outcome Time Frame:

at 12 months from start of treatment

Safety Issue:


Principal Investigator

John A. Dumot, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

December 2008

Related Keywords:

  • Barretts Esophagus
  • Esophageal Cancer
  • Barrett's Esophagus
  • Cryospray ablation
  • High Grade Dysplasia
  • Early Esophageal Cancers
  • Esophageal Neoplasms
  • Esophageal Intramucosal Cancer (IMCA)
  • Esophageal Cancer limited to esophageal wall
  • Barretts esophagus High Grade Dysplasia (HGD)
  • Barrett Esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms



The Cleveland Clinic Cleveland, Ohio  44195