Anal Intraepithelial Neoplasia (AIN)NCT02189161
A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia
A study testing Radiofrequency Ablation (Barrx™) in people with Anal Intraepithelial Neoplasia (AIN) and High-grade Squamous Intraepithelial Lesions (HSIL), run by Medtronic - MITG at 1 site in United States.
Trial summary
Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN). Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA will be applied using the Barrx™ Ablation System. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anal Intraepithelial Neoplasia (AIN), High-grade Squamous Intraepithelial Lesions (HSIL)
- What is being tested?
- Radiofrequency Ablation (Barrx™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Aug 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
- Candidates for this study must meet all of the following criteria:
- Age 18-75 years
- HRA 2 to 8 weeks prior to the 0 month RFA visit yielding one or more flat, non-condylomatous biopsy-proven HSILs that are
- Located entirely within the eligible treatment zone AND
- 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 AND
- Full anorectal circumference
- 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).
- If HIV positive
- HIV positive on antiretroviral therapy for at least 3 months with laboratory blood work within 12 weeks prior to the 0 month visit demonstrating viral load < 50
- CD4 count ≥ 250/mm3
- ANC > 750/mm3
- Platelet count ≥ 75,000/mm3
- Hemoglobin ≥ 9.0 g/dl
- INR and PTT normal
Who cannot join
- Candidates will be ineligible for enrollment in the study if any of the following conditions apply:
- Any biopsy-proven HSIL partially outside of 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) before or during Visit 1 (0 month RFA visit)
- Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, or proctitis
- Any anal stricture or stenosis in patient history or upon examination.
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- Symptomatic scarring in anal canal (i.e. not pliable, hyperkeratosis)
- 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 within 6 months prior to the 0 month RFA visit (other than cauterization or excision of condyloma(s))
- Prior ablation or resection therapy consisting of ≥ 75% circumference within the ETZ of anal canal.
- History of topical therapy (e.g. Imiquimod, 5-FU, Trichloroacetic acid) within the ETZ within 3 months prior to the 0 month RFA visit
- Hemorrhoids > grade III
- Fecal incontinence
- Concurrent disease requiring systemic immunosuppression therapy
- Concurrent malignancy requiring systemic therapy
- Life expectancy < 2 years
- Subject is on a platelet inhibiting agent (i.e. Aspirin, Clopidogrel, NSAIDS) and/or anti-thrombotic agent (Heparin, Warfarin) and unable to discontinue 7 days before and after treatment for 14 days total.
- Exception: Aspirin 81 mg PO daily does not need to be discontinued
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Tolerability Trial of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia Using the Barrx™ Ablation System
Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN). Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA will be applied using the Barrx™ Ablation System.
- Being tested
- Radiofrequency Ablation (Barrx™)
- Keywords
- anal intraepithelial neoplasia, AIN, Radiofrequency Ablation, RFA
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Ablation (Barrx™)Device
Also called Barrx™ Ablation System
Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation | Experimental | circumferential radiofrequency ablation (RFA) to the anal canal Receives: Device: Radiofrequency Ablation (Barrx™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Related Adverse Events
Adverse event : Device relationship - Definite, Probable, Possible
Measured: Within 12 months post RFA
Secondary outcomes (2)
Subject Tolerability: Post -Ablation Anal Pain
Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)
Measured: within 4 weeks post RFA
Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition
Median from subject scores for worry about anal canal condition at 0-2 weeks prior to RFA treatment and after 9-12 months post RFA. Median scale range: 0-10 (minimum concern=0, maximum concern=10)
Measured: 0-2 weeks Prior RFA and after 9-12 months post RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2015
- Study completionAug 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal Intraepithelial Neoplasia (AIN)Studies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189161
- Sponsor's protocol ID
- B-253
- Status last verified
- Jun 2016
- First submitted
- 10 Jul 2014
- Last updated
- 14 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Goldstone RN, Hasan SR, Goldstone SE. Brief Report: Radiofrequency Ablation Therapy for Anal Intraepithelial Neoplasia: Results From a Single-Center Prospective Pilot Study in HIV+ Participants. J Acquir Immune Defic Syndr. 2017 Dec 1;76(4):e93-e97. doi: 10.1097/QAI.0000000000001535.
PubMed 28857936
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Tolerability Trial of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia Using the Barrx™ Ablation System
- ClinicalTrials.gov ID
- NCT02189161
- Acronym / sponsor ID
- B-253
- Keywords
- anal intraepithelial neoplasia, AIN, Radiofrequency Ablation, RFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 14 Jul 2014 (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.
Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN). Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA will be applied using the Barrx™ Ablation System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation | Experimental | Device: Radiofrequency Ablation (Barrx™)circumferential radiofrequency ablation (RFA) to the anal canal |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18-75 years
- HRA 2 to 8 weeks prior to the 0 month RFA visit yielding one or more flat, non-condylomatous biopsy-proven HSILs that are
- Eligible treatment zone (ETZ) is defined as
- 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).
- If HIV positive
Key exclusion criteria (20 listed)
- Candidates will be ineligible for enrollment in the study if any of the following conditions apply:
- Any biopsy-proven HSIL partially outside of 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, or proctitis
- Any anal stricture or stenosis in patient history or upon examination.
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 (Barrx™)Also: Barrx™ Ablation SystemAnal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2. | Device | Radiofrequency Ablation |
Primary outcome
Related Adverse Events
Time frame: Within 12 months post RFA
Adverse event : Device relationship - Definite, Probable, Possible
2 secondary outcomes
Subject Tolerability: Post -Ablation Anal Pain
Time frame: within 4 weeks post RFA
Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition
Time frame: 0-2 weeks Prior RFA and after 9-12 months post RFA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28857936Goldstone RN, Hasan SR, Goldstone SE. Brief Report: Radiofrequency Ablation Therapy for Anal Intraepithelial Neoplasia: Results From a Single-Center Prospective Pilot Study in HIV+ Participants. J Acquir Immune Defic Syndr. 2017 Dec 1;76(4):e93-e97. doi: 10.1097/QAI.0000000000001535.
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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?
A study testing Radiofrequency Ablation (Barrx™) in people with Anal Intraepithelial Neoplasia (AIN) and High-grade Squamous Intraepithelial Lesions (HSIL), run by Medtronic - MITG at 1 site in United States.
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 16 inclusion and 20 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 14 Jul 2016. 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?
Related Adverse Events (time frame: Within 12 months post RFA). 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 NCT02189161, which also lists 1 linked publication.
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 14 Jul 2016.