C2 Esophageal Squamous Epithelium Dysplasia

Официальное название

A Prospective, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of C2 CryoBalloonTM Ablation System in Patients With Esophageal Squamous Epithelium Dysplasia

Обзор

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.

Вмешательства

• Устройство C2 CryoBalloonTM Ablation System.
  Cryoablation is used to ablate the tissue under the cryogenic condition. The device is mainly used to destroy the unhealthy tissues.

Первичные конечные точки

• Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area [Срок оценки: 12 Month]

Вторичные конечные точки (2)

• 1) Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial by one time of treatment [Срок оценки: 12 Month]
• 2) Percentage of patients with complete remission of all the moderate to severe dysplasia in initial treatment area [Срок оценки: 12 Month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

Критерии включения

• 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.

Критерии исключения

• 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.

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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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• The First Bethune Hospital of Jilin University — Changchun
• Changzhi People's Hospital — Changzhi
• The Second Hospital of Hebei Medical University — Shijiazhuang

Идентификаторы

NCT: NCT05349240 · CBAS_DIII_19001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗