Esophageal Squamous Epithelium Dysplasia
Conditions
Brief summary
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.
Interventions
DEVICEC2 CryoBalloonTM Ablation System.
Cryoablation is used to ablate the tissue under the cryogenic condition. The device is mainly used to destroy the unhealthy tissues.
Sponsors
Pentax Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female of 18 to 80 years old (including 18 and 80 years old). 2. At least one unstained lesion (USL) in the esophagus upon high resolution upper gastrointestinal endoscopy with Lugol's staining. Flat (Paris type 0-IIb) USL, with the total area of one or more USLs having a maximum longitudinal size of 6 cm and covering a maximum of one-half of the esophageal circumference. 3. Patients with one or more biopsy confirmed esophageal squamous epithelium dysplasia areas within 6 months prior to enrollment, and the pathological diagnosis is moderate to severe esophageal squamous epithelium dysplasia. 4. No potential of lymph node metastasis by preoperative comprehensive evaluation.
Exclusion criteria
Inclusion criteria: 1. Male or female of 18 to 80 years old (including 18 and 80 years old). 2. At least one unstained lesion (USL) in the esophagus upon high resolution upper gastrointestinal endoscopy with Lugol's staining. Flat (Paris type 0-IIb) USL, with the total area of one or more USLs having a maximum longitudinal size of 6 cm and covering a maximum of one-half of the esophageal circumference. 3. Patients with one or more biopsy confirmed esophageal squamous epithelium dysplasia areas within 6 months prior to enrollment, and the pathological diagnosis is moderate to severe esophageal squamous epithelium dysplasia. 4. No potential of lymph node metastasis by preoperative comprehensive evaluation. 5. The patients are self volunteered to participate in the trial and will sign an informed consent form prior to enroll.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area | 12 Month | Percentage of complete remission at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1) Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial by one time of treatment | 12 Month | Percentage of patients who need only 1 treatment |
| 2) Percentage of patients with complete remission of all the moderate to severe dysplasia in initial treatment area | 12 Month | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoints | 12 Months | Frequency of adverse events and frequency of device related adverse events |
Countries
China
Contacts
Primary ContactGuiqi Wang, MD
Backup ContactYan Ke, MD
Outcome results
None listed