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:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT02047305
Eligibility Criteria:
Inclusion Criteria:
1. Subject is 18-80 years of age, inclusive
2. Subject meets at least one of the following inclusion criteria:
1. Within the last 3 months, subject demonstrated a new diagnosis or a reconfirmed diagnosis of squamous MGIN and/or HGIN of the esophagus, or...
2. within the last 3 months, subject demonstrated a new diagnosis of a flat-type (type 0-IIb) SCCA (G1/G2 only)
3. On endoscopic examination, subject has at least one USL that measures at least 3 cm in at least one dimension and has MGIN or worse (MGIN+) on biopsy
4. The maximum allowable linear length of "USL-bearing esophagus" is 12 cm
5. Baseline EUS (all patients) shows no exclusionary findings for the trial
6. CT scan of chest and upper third of the abdomen (all HGIN and SCCA patients) shows no exclusionary findings for the trial
7. Subject is not pregnant nor has plans to become pregnant in the ensuing 12 months (confirmation of non-pregnant status in women of child-bearing age and ability required with urine or blood test)
8. Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the protocol
9. The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation
Exclusion Criteria:
the Eligibility CRF.
1. Esophageal stricture preventing passage of a therapeutic endoscope
2. Any prior endoscopic resection
3. Any esophageal dilation in the past 12 months
4. Any history of a non-squamous cell cancer of the esophagus, or any history of a squamous cell cancer of the esophagus (any stage) prior to 3 months before screening for this trial
5. Any N or M positive status, if patient has a present diagnosis of esophageal SCCA
6. Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other) or any radiation therapy to the esophagus.
7. Any previous esophageal surgery, except fundoplication without complications (i.e. no slippage, dysphagia, etc)
8. Evidence of esophageal varices detected within last 6 months or at initial RFA procedure
9. Evidence of eosinophilic esophagitis on endoscopy and/or histology
10. Report of uncontrolled coagulopathy with international normalized ratio (INR) \> 2 or platelet count \<75,000 platelets per µL (note: a complete blood count is not required for all subjects in this study)
11. Subject is using aspirin, clopidogrel, or non-steroidal anti-inflammatory drugs that can not be discontinued 7 days before and after therapeutic sessions
12. Subject has a 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
13. Subject has an implantable pacing device (examples; AICD, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device
14. Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol
15. Subject has life expectancy less than 2 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02047305
Study Brief:
Protocol Section:
NCT02047305