A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System

Inclusion criteria

• Age 18-75 years
• HRA 2 to 12 weeks prior to the 0 month RFA visit yielding one or more flat, non-condylomatous biopsy-proven HSILs that are

• Located entirely within in the eligible treatment zone
• Contiguous with the squamocolumnar junction Eligible treatment zone (ETZ) is defined as

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• 3 cm above the dentate line to the anocutaneous line
• Half of the anorectal circumference (meaning no more than two contiguous quadrants)
• If female of child-bearing age, negative pregnancy test within 8 weeks of the 0 month RFA visit and declared intent to remain on birth control throughout the trial, or, declaration of infertility defined as subject report of status as post-menopausal or surgically sterile (status post hysterectomy or tubal ligation).
• HIV negative, ELISA/Western blot test obtained within 12 weeks of the 0 month RFA visit

Exclusion criteria

• Any biopsy-proven HSIL entirely outside of the ETZ
• Any biopsy-proven HSIL partially within the ETZ (for example, an HSIL lesion with extension to the perianal skin)
• Any condylomas in the eligible treatment zone > 1/2 cm diameter

• Note: Condylomas in the eligible treatment zone < 1/2 cm in diameter must be excised or cauterized (not treated topically or with IRC) before or during Visit 1 (0 month RFA visit)
• Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, stenosis or proctitis
• History of or present anal or rectal cancer
• History of pelvic radiation therapy
• History of HPV vaccination or plans to initiate HPV vaccination during the trial
• History of ablation or resection therapy within the ETZ other than cauterization or excision of condyloma(s)
• History of topical therapy (Imiquimod, 5-FU) within 6 months prior to the 0 month RFA visit within the ETZ
• Hemorrhoids > grade II
• Fecal incontinence (that the investigator feels may impair healing)
• Concurrent disease requiring systemic immunosuppression therapy
• Concurrent malignancy requiring systemic therapy
• Life expectancy < 2 years