Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT01802203
Eligibility Criteria:
Inclusion Criteria:
1. GI conditions include:
* Barrett's Esophagus (BE) with or without dysplasia
* Squamous dysplasia
* Esophageal cancer, any stage
2. 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
Exclusion Criteria:
1. 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
2. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01802203
Study Brief:
Protocol Section:
NCT01802203