Radiofrequency Ablation for Patients With Esophageal Squamous Cell Neoplasia

A patient population with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, in lesions measuring 3 to 12cm in length, will be treated with radiofrequency ablation (RFA) using the HALO ablation system. Additional RFA sessions will be performed on 3 month intervals until complete response (CR; no MGIN or worse in biopsies) will be achieved. All patients will then undergo an endoscopy at 12 months after baseline. Patients with CR at 12 months will be followed-up for 5 years with annual endoscopy and biopsies, and additional treatment if necessary. Patients with no CR at 12 months are considered failures.

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
• Baseline EUS (all patients) shows no exclusionary findings for the trial
• 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

Exclusion criteria

the Eligibility CRF.

• Esophageal stricture preventing passage of a therapeutic endoscope
• Any prior endoscopic resection
• Any esophageal dilation in the past 12 months
• 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
• Any N or M positive status, if patient has a present diagnosis of esophageal SCCA
• 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.
• Any previous esophageal surgery, except fundoplication without complications (i.e. no slippage, dysphagia, etc)
• Evidence of esophageal varices detected within last 6 months or at initial RFA procedure
• Evidence of eosinophilic esophagitis on endoscopy and/or histology
• 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)
• Subject is using aspirin, clopidogrel, or non-steroidal anti-inflammatory drugs that can not be discontinued 7 days before and after therapeutic sessions
• 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
• 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
• Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol
• Subject has life expectancy less than 2 years