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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Intervention | Experimental | All subjects will receive treatment with the study device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C2 CryoBalloonTM Ablation System. | Device | Cryoablation is used to ablate the tissue under the cryogenic condition. The device is mainly used to destroy the unhealthy tissues. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area | Percentage of complete remission at 12 months | 12 Month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 Month |
| 2) Percentage of patients with complete remission of all the moderate to severe dysplasia in initial treatment area |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints | Frequency of adverse events and frequency of device related adverse events | 12 Months |
Inclusion Criteria:
Exclusion Criteria:
Inclusion criteria:
Exclusion criteria:
9) Patients with unstable vital signs 10) Anti-human immunodeficiency virus (HIV) antibody positive, both syphilis serology Treponema pallidum-specific antibody test and rapid plasma reagin positive.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guiqi Wang, MD | Contact | 0086-10-87788547 | wangguiq@126.com | |
| Yan Ke, MD | Contact | 0086-13520186688 | keyan@cicams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guiqi Wang, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
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| 12 Month |
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | China |
|
| Changzhi People's Hospital | Recruiting | Changzhi | China |
|
| The Second Hospital of Hebei Medical University | Recruiting | Shijiazhuang | China |
|