NCT05349240招募中不适用
A Prospective, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of C2 CryoBalloonTM Ablation System in Patients With Esophageal Squamous Epithelium Dysplasia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 129
- 试验地点
- 4
- 主要终点
- Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of 18 to 80 years old (including 18 and 80 years old).
- •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.
- •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.
- •No potential of lymph node metastasis by preoperative comprehensive evaluation.
排除标准
- •Inclusion criteria:
- •Male or female of 18 to 80 years old (including 18 and 80 years old).
- •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.
- •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.
- •No potential of lymph node metastasis by preoperative comprehensive evaluation.
- •The patients are self volunteered to participate in the trial and will sign an informed consent form prior to enroll.
- •Exclusion criteria:
- •Females who are pregnant, lactating or plan to get pregnant during the study.
- •Known hypersensitivity to iodine.
- •Lesions within the target area such as: obvious ulcer; varices at risk of bleeding; active inflammation due to esophageal reflux into the treatment area; lesions view being not flat, or containing unfavourable unstained lesions (USLs) outside the designated treatment areas.
- •Esophageal stenosis preventing the passage of the endoscope to the treatment area. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope within 4 cm of the treatment area.
- •Having previously received Heller surgery: any previous ablative esophageal surgery (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment) or any previous esophageal surgery except for anti-reflux surgery.
- •Suffering from any cancer in the past 5 years.
- •Severe bleeding potential; patients on anti-coagulative therapy or stopping using anti-coagulative drugs for less than 7 days before enrollment or with impaired coagulation.
- •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.
结局指标
主要结局
Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area
时间窗: 12 Month
Percentage of complete remission at 12 months
次要结局
- 2) Percentage of patients with complete remission of all the moderate to severe dysplasia in initial treatment area(12 Month)
- 1) Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial by one time of treatment(12 Month)
研究者
研究点 (4)
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