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 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT03285035
Eligibility Criteria:
Inclusion Criteria:
* Has esophageal or gastroesophageal cancer and will be receiving chemotherapy
* Dysphagia score of 1, 2, 3 or 4.
* Age ≥18 years old
* American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 4
* Deemed not a candidate for esophageal cancer surgical resection
* Female subjects must be either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., total abstinence, birth control pills, an intrauterine device (IUD), diaphragm, progesterone injections or implants, or condoms plus a spermicide) for the duration of the study
Exclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
* Patient who received radiation treatment in the prior 8 weeks
* Known brain metastases causing cranial nerve deficits which can cause dysphagia
* Inability to undergo an esophagogastroduodenoscopy (EGD)
* Pregnant or nursing
* Surgery or anatomy where capacity of stomach is reduced making cryotherapy contraindicated
* Patients with tracheoesophageal fistula
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03285035
Study Brief:
Protocol Section:
NCT03285035