HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial LesionsAINNCT01970787

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

A study testing Radiofrequency Ablation (RFA) using the HALO Ablation System in people with HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions, run by Medtronic - MITG at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
What is being tested?: Radiofrequency Ablation (RFA) using the HALO Ablation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
3 cm above the dentate line to the anocutaneous line

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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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Laser Surgery Center
New York, New York, 10011

Other trials in United States

About this study

This is a Single-center prospective pilot trial involving up to 22 subjects. This study will assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal canal using the FDA cleared HALO Ablation System to eradicate anal HSIL lesions in HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN). The study intervention will demonstrate that a reasonable proportion of subjects will be histologically cleared of their anal HSIL within the ETZ in a tolerable and relatively safe manner

Conditions: HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
Being tested: Radiofrequency Ablation (RFA) using the HALO Ablation System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiofrequency Ablation (RFA) using the HALO Ablation SystemDevice
Also called Barrx Ablation System

Study groups in NCT01970787
Study group	Role	What they receive
RFA	Experimental	Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions Receives: Device: Radiofrequency Ablation (RFA) using the HALO Ablation System

What is being measured

The primary outcome is the main question the study is designed to answer.

Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL)
Participants with histologic clearance of anal HSIL within the ETZ (eligible treatment zone) at 12 months from first RFA treatment
Measured: 12 months

Secondary outcomes (4)

Feasibility and Ease of Technique
Technical feasibility of applying RFA to the anal canal. Physician's assessment of ablation as optimal (complete ablation) versus sub-optimal (incomplete ablation)in the affected area in the anal canal.
Data not collected and could not be analyzed
Measured: 12 months
Tolerability
Subject tolerability of the RFA procedure as measured by severity. Mild: Awareness of signs and symptoms, but easily tolerated; are of a minor irritant type; causing no loss of time from normal activities; symptoms would not require medication or a medical intervention; asymptomatic lab findings; marginal clinical relevance; signs and symptoms are transient.
Moderate: Discomfort severe enough to cause interference with usual activities; minimal intervention.
Severe: Incapacitating with inability to do work or usual activities; signs and symptoms may be of systemic nature or require medical evaluation or treatment.
Measured: 12 months
Adverse Events
Any related adverse event occuring in patients enrolled in this study. Event type and relationship to the device or procedure will be measured.
Measured: 12 months
Progression of HSIL to Cancer
Histologic progression of HSIL to cancer as measured in biopsies read at the central pathology lab. Data not collected and could not be analyzed.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Jun 2015

First posted28 Oct 2013 (estimated)
Study startMar 2013
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial LesionsStudies of the same condition, open and under way.
More trials run by Medtronic - MITGThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01970787
Sponsor's protocol ID: B-250
Acronym: AIN
Status last verified: Dec 2016
First submitted: 22 Oct 2013
Last updated: 6 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System
ClinicalTrials.gov ID: NCT01970787
Acronym / sponsor ID: AIN / B-250
Conditions: HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 28 Oct 2013 (estimated)
Results: Posted 14 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
RFA	Experimental	Device: Radiofrequency Ablation (RFA) using the HALO Ablation SystemAssess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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
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

Key exclusion criteria (15 listed)

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
Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, stenosis or proctitis
History of or present anal or rectal cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiofrequency Ablation (RFA) using the HALO Ablation SystemAlso: Barrx Ablation System	Device	RFA

Primary outcome

Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL)
Time frame: 12 months
Participants with histologic clearance of anal HSIL within the ETZ (eligible treatment zone) at 12 months from first RFA treatment

4 secondary outcomes

Feasibility and Ease of Technique
Time frame: 12 months
Tolerability
Time frame: 12 months
Adverse Events
Time frame: 12 months
Progression of HSIL to Cancer
Time frame: 12 months

Results and safety

Results posted to the registry on 14 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RFA Treatment	22	21

Primary outcome: Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL)

Time frame: 12 months. Number. Unit: participants w histological clearance

Measure	RFA Treatment n = 21
Value	19

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RFA Treatment	0 of 21 (0%)	2 of 21 (9.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01970787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.