trūFreeze® Spray Cryotherapy Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 275
- 试验地点
- 16
- 主要终点
- Collect efficacy and outcome data related to the use of trūFreeze® spray cryotherapy for treatment of unwanted tissue in the pulmonary and gastrointestinal settings.
研究概览
简要总结
To collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy for the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.
详细描述
This is a prospective, multi-center registry of patients who are currently undergoing spray cryotherapy using the trūFreeze® device. The registry population consists of patients who are being treated using the spray cryotherapy trūFreeze® device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.
Patients eligible to participate in the registry will have disease and treatment specific data collected throughout therapy and long-term follow-up. Subjects will be considered to have completed the registry when data from the 5 year follow-up visit has been collected. The beginning of the follow-up period commences with the first endoscopic treatment session.
Subjects may be withdrawn prior to this for any of the following reasons:
- Death, or
- Lost to Follow-Up, or
- Withdrawal of consent, or
- Discontinuation by the investigator. Three attempts at contact using two different methods are required prior to determination that the subject is lost to follow-up. Attempts at contact must be with certified letters OR documented telephone contact.
The registry will utilize electronic case report forms using a web-based platform housed at the University of North Carolina at Chapel Hill. Access to the database will be limited to individuals involved in the research registry and will require a unique user ID and password. All access to the database and web-based application will be encrypted (HTTPS) and electronic systems compliant with applicable privacy and security regulations. To maintain patient confidentiality, all subjects will be assigned a registry identification number, and this will be the only link between subject identity and treatment information. Read-only access will be provided to any personnel who is not an administrator or responsible for data entry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GI conditions include:
- •Barrett's Esophagus (BE) with or without dysplasia
- •Squamous dysplasia
- •Esophageal cancer, any stage
- •Pulmonary conditions include:
- •Any endobronchial cancerous or precancerous disease located within the central airways
- •Any non-malignant endobronchial process of the central airways that results in abnormal mucosa (i.e. granulation tissue, papillomatosis, sarcoidosis, tuberculosis, etc.)
- •Tracheal or bronchial stenosis (malignant or benign)
- •Any pleural disease, malignant or benign All subjects are required to be able to provide written informed consent
排除标准
- •Gastrointestinal Exclusion Criteria
- •Contraindication to spray cryotherapy.
- •Prior treatment with spray cryotherapy. Previous or concurrent treatment using other mucosal therapies such as endoscopic mucosal resection or radiofrequency ablation is acceptable.
- •Below 18 years of age
- •Pulmonary Exclusion Criteria
- •Contraindication to spray cryotherapy.
- •Prior treatment with spray cryotherapy. Previous or concurrent treatment using other mucosal therapies is acceptable.
- •Tracheoesophageal fistula.
- •Bronchopleural fistula.
- •Current untreated pneumothorax.
- •Clinically significant hypoxia refractory to supplemental oxygen therapy.
- •Below 18 years of age
结局指标
主要结局
Collect efficacy and outcome data related to the use of trūFreeze® spray cryotherapy for treatment of unwanted tissue in the pulmonary and gastrointestinal settings.
时间窗: 5 years
The registry population consists of patients who are being treated using the trūFreeze® spray cryotherapy device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.
次要结局
- Collect safety data related to the use of trūFreeze® spray cryotherapy for treatment in the pulmonary and gastrointestinal settings.(5 years)