This study will evaluate the efficacy and safety of C2 CryoBalloonTM Ablation System for the cryoablation of dysplastic squamous tissue in patients with moderate to severe esophageal squamous epithelium dysplasia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Cryoablation is used to ablate the tissue under the cryogenic condition. The device is mainly used to destroy the unhealthy tissues.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGThe First Bethune Hospital of Jilin University
Changchun, China
RECRUITINGChangzhi People's Hospital
Changzhi, China
RECRUITINGPercentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area
Percentage of complete remission at 12 months
Time frame: 12 Month
1) Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial by one time of treatment
Percentage of patients who need only 1 treatment
Time frame: 12 Month
2) Percentage of patients with complete remission of all the moderate to severe dysplasia in initial treatment area
Time frame: 12 Month
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The Second Hospital of Hebei Medical University
Shijiazhuang, China
RECRUITING