Trial Outcomes & Findings for A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia (NCT NCT02189161)

Results Overview

Adverse event : Device relationship - Definite, Probable, Possible

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Within 12 months post RFA

Results posted on

2016-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Radiofrequency Ablation circumferential radiofrequency ablation (RFA) to the anal canal Radiofrequency Ablation (Barrx™): 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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiofrequency Ablation n=10 Participants circumferential radiofrequency ablation (RFA) to the anal canal Radiofrequency Ablation (Barrx™): 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.
Age, Continuous	51.5 years STANDARD_DEVIATION 12.35 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants

PRIMARY outcome

Timeframe: Within 12 months post RFA

Adverse event : Device relationship - Definite, Probable, Possible

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation n=10 Participants circumferential radiofrequency ablation (RFA) to the anal canal Radiofrequency Ablation (Barrx™): 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.
Related Adverse Events Definite	1 number of participants
Related Adverse Events Probable	1 number of participants

SECONDARY outcome

Timeframe: within 4 weeks post RFA

Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation n=10 Participants circumferential radiofrequency ablation (RFA) to the anal canal Radiofrequency Ablation (Barrx™): 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.
Subject Tolerability: Post -Ablation Anal Pain	5 units on a scale Interval 2.0 to 9.0

SECONDARY outcome

Timeframe: 0-2 weeks Prior RFA and after 9-12 months post RFA

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)

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation n=10 Participants circumferential radiofrequency ablation (RFA) to the anal canal Radiofrequency Ablation (Barrx™): 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.
Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition 0-2 weeks Prior RFA	4.5 units on a scale Interval 0.0 to 8.0
Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition 9 to 12 months post RFA	0.5 units on a scale Interval 0.0 to 5.0

Adverse Events

Radiofrequency Ablation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Radiofrequency Ablation n=10 participants at risk circumferential radiofrequency ablation (RFA) to the anal canal Radiofrequency Ablation (Barrx™): 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.
Injury, poisoning and procedural complications Anal Stricture	10.0% 1/10 • Number of events 1
Injury, poisoning and procedural complications External thrombosed Hemorrhoids	10.0% 1/10 • Number of events 1

Additional Information

Dr. Stephen E. Goldstone, MD

Laser Surgery Care

Phone: 212-242-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60