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 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT02605759
Eligibility Criteria:
Inclusion Criteria:
* At least one unstained lesion (USL) in the esophagus upon high resolution endoscopy with Lugol's staining
* Flat (type 0-IIb) appearance of the USL
* Total area of USLs is a maximum longitudinal size of 6cm and covering a maximum of one-half of the circumference of the esophagus
* Proven (by histopathological analysis) medium-grade or high-grade intraepithelial neoplasia (MGIN or HGIN) in at least one USL
* Older than 18 years of age at time of consent
* Operable per institution's standards
* Provides written informed consent on the Ethics Committee-approved informed consent form
* Willing and able to comply with study requirements for follow-up
Exclusion Criteria:
* Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope within 4cm of the treatment zone
* Other USLs containing MGIN, HGIN, or ESSC outside the designated treatment area
* Any previous ablative therapy in the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment) or any radiation therapy to the esophagus
* Any previous esophageal surgery (except anti-reflux surgery)
* Any cancer (squamous cell or non-squamous cell) within the previous five (5) years
* Active inflammation in the treatment zone due to esophageal reflux, as confirmed by endoscopic examination
* Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines
* Pregnant or planning to become pregnant during the study follow-up period
* Life expectancy ≤2 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02605759
Study Brief:
Protocol Section:
NCT02605759