Recruitment

Recruitment Status
Completed

Inclusion Criterias

Half of the anorectal circumference (meaning no more than two contiguous quadrants)
Age 18-75 years
Located entirely within in the eligible treatment zone
...
Half of the anorectal circumference (meaning no more than two contiguous quadrants)
Age 18-75 years
Located entirely within in the eligible treatment zone
HIV negative, ELISA/Western blot test obtained within 12 weeks of the 0 month RFA visit
3 cm above the dentate line to the anocutaneous line
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).
Contiguous with the squamocolumnar junction Eligible treatment zone (ETZ) is defined as

Exclusion Criterias

History of topical therapy (Imiquimod, 5-FU) within 6 months prior to the 0 month RFA visit within the ETZ
Life expectancy < 2 years
Hemorrhoids > grade II
...
History of topical therapy (Imiquimod, 5-FU) within 6 months prior to the 0 month RFA visit within the ETZ
Life expectancy < 2 years
Hemorrhoids > grade II
History of or present anal or rectal cancer
History of ablation or resection therapy within the ETZ other than cauterization or excision of condyloma(s)
History of HPV vaccination or plans to initiate HPV vaccination during the trial
Concurrent malignancy requiring systemic therapy
Concurrent disease requiring systemic immunosuppression therapy
Any biopsy-proven HSIL entirely outside of the ETZ
Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, stenosis or proctitis
Any biopsy-proven HSIL partially within the ETZ (for example, an HSIL lesion with extension to the perianal skin)
History of pelvic radiation therapy
Fecal incontinence (that the investigator feels may impair healing)

Summary

Conditions
HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Inclusion Criterias

Half of the anorectal circumference (meaning no more than two contiguous quadrants)
Age 18-75 years
Located entirely within in the eligible treatment zone
...
Half of the anorectal circumference (meaning no more than two contiguous quadrants)
Age 18-75 years
Located entirely within in the eligible treatment zone
HIV negative, ELISA/Western blot test obtained within 12 weeks of the 0 month RFA visit
3 cm above the dentate line to the anocutaneous line
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).
Contiguous with the squamocolumnar junction Eligible treatment zone (ETZ) is defined as

Exclusion Criterias

History of topical therapy (Imiquimod, 5-FU) within 6 months prior to the 0 month RFA visit within the ETZ
Life expectancy < 2 years
Hemorrhoids > grade II
...
History of topical therapy (Imiquimod, 5-FU) within 6 months prior to the 0 month RFA visit within the ETZ
Life expectancy < 2 years
Hemorrhoids > grade II
History of or present anal or rectal cancer
History of ablation or resection therapy within the ETZ other than cauterization or excision of condyloma(s)
History of HPV vaccination or plans to initiate HPV vaccination during the trial
Concurrent malignancy requiring systemic therapy
Concurrent disease requiring systemic immunosuppression therapy
Any biopsy-proven HSIL entirely outside of the ETZ
Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, stenosis or proctitis
Any biopsy-proven HSIL partially within the ETZ (for example, an HSIL lesion with extension to the perianal skin)
History of pelvic radiation therapy
Fecal incontinence (that the investigator feels may impair healing)

Locations

New York, New York, 10011
New York, New York, 10011

Tracking Information

NCT #
NCT01970787
Collaborators
Not Provided
Investigators
Not Provided