Radiofrequency Ablation for Patients With Esophageal Squamous Cell Neoplasia (NCT02047305) | Clinical Trial Compass
CompletedNot Applicable
Radiofrequency Ablation for Patients With Esophageal Squamous Cell Neoplasia
China96 participantsStarted 2009-01
Plain-language summary
Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subject is 18-80 years of age, inclusive
✓. Subject meets at least one of the following inclusion criteria:
✓. Within the last 3 months, subject demonstrated a new diagnosis or a reconfirmed diagnosis of squamous MGIN and/or HGIN of the esophagus, or...
✓. within the last 3 months, subject demonstrated a new diagnosis of a flat-type (type 0-IIb) SCCA (G1/G2 only)
✓. 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
✓. The maximum allowable linear length of "USL-bearing esophagus" is 12 cm
Exclusion criteria
✕. CT scan of chest and upper third of the abdomen (all HGIN and SCCA patients) shows no exclusionary findings for the trial
✕. 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)
✕. Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the protocol
✕. The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation
✕. Esophageal stricture preventing passage of a therapeutic endoscope
✕. 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