Trial Outcomes & Findings for RFA for Flat Type High-grade and Medium-grade Intraepithelial Squamous Neoplasia (NCT NCT02953418)

Results Overview

The primary endpoint is the percentage of subjects with "complete response (CR)", defined as complete eradication of squamous histological abnormalities (MGIN or worse) within the treatment area (TA) at 12 months after the initial treatment session

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

12 month

Results posted on

2020-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Radiofrequency Ablation Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months. Radiofrequency ablation: RFA
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RFA for Flat Type High-grade and Medium-grade Intraepithelial Squamous Neoplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiofrequency Ablation n=34 Participants Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months. Radiofrequency ablation: RFA
Age, Continuous	62.41 years STANDARD_DEVIATION 8.03 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	34 Participants n=5 Participants
Height (cm)	162.88 cm STANDARD_DEVIATION 7.79 • n=5 Participants
Weight (kg)	64.93 kg STANDARD_DEVIATION 10.30 • n=5 Participants

PRIMARY outcome

Timeframe: 12 month

Population: As the study was terminated early, only 8 subjects completed 12 month follow up.

The primary endpoint is the percentage of subjects with "complete response (CR)", defined as complete eradication of squamous histological abnormalities (MGIN or worse) within the treatment area (TA) at 12 months after the initial treatment session

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation n=8 Participants Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months. Radiofrequency ablation: RFA
Percentage of Subjects With Complete Response (CR)	8 Participants

SECONDARY outcome

Timeframe: 3 Months

Number of patients with a CR after primary RFA, defined as absence of MGIN or worse in any of the biopsies from the treatment area at the three months visit

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation n=34 Participants Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months. Radiofrequency ablation: RFA
Complete Response at Three Months	5 Participants

SECONDARY outcome

Timeframe: 3, 6 and 12 Month

Population: Not all patients in the study were followed for the duration of the treatment phase of 12 months due to study termination. Therefore, primary and secondary endpoint data sample size may vary based on how many visits each subject completed.

Number of patients demonstrating complete response within the treatment area (TA), defined as detection of ESCC in biopsy or resection specimen at any time within the first 12 months.

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation n=34 Participants Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months. Radiofrequency ablation: RFA
Complete Response Within the Treatment Area 3 Month Complete Response	5 Participants
Complete Response Within the Treatment Area 6 Month Complete Response	22 Participants
Complete Response Within the Treatment Area 12 Month Complete Response	14 Participants

SECONDARY outcome

Timeframe: Initial, 3, 6, 9 and 12 month

Population: Not all patients in the study were followed for the duration of the treatment phase of 12 months due to study termination. Therefore, primary and secondary endpoint data sample size may vary based on how many visits each subject completed.

Proportion of patients demonstrating MGIN or worse outside the TA during treatment phase or follow-up

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation n=34 Participants Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months. Radiofrequency ablation: RFA
Disease Progression Outside the Treatment Area Primary RFA	1 Participants
Disease Progression Outside the Treatment Area 3-Month	9 Participants
Disease Progression Outside the Treatment Area 6-Month	6 Participants
Disease Progression Outside the Treatment Area 9-Month	4 Participants
Disease Progression Outside the Treatment Area 12-Month	1 Participants

Adverse Events

Radiofrequency Ablation

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Radiofrequency Ablation n=34 participants at risk Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months. Radiofrequency ablation: RFA
Gastrointestinal disorders Oesophageal stenosis	2.9% 1/34 • Number of events 1 • Safety data was evaluated throughout the entirety of follow up, after the study was terminated safety was evaluated for 90 days post RFA procedure.
Infections and infestations H1N1Influenza	2.9% 1/34 • Number of events 1 • Safety data was evaluated throughout the entirety of follow up, after the study was terminated safety was evaluated for 90 days post RFA procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the hypopharynx	2.9% 1/34 • Number of events 1 • Safety data was evaluated throughout the entirety of follow up, after the study was terminated safety was evaluated for 90 days post RFA procedure.

Other adverse events

Other adverse events
Measure	Radiofrequency Ablation n=34 participants at risk Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months. Radiofrequency ablation: RFA
Gastrointestinal disorders Oesophageal stenosis	2.9% 1/34 • Number of events 1 • Safety data was evaluated throughout the entirety of follow up, after the study was terminated safety was evaluated for 90 days post RFA procedure.

Additional Information

Director of Clinical Affairs

Medtronic MITG-RGI

Phone: 303-882-6759

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution and Investigator shall not publish the Study results until after Medtronic's multi-site publication or until the elapse of 12 months from the close of the study at all Study sites, whichever occurs earlier.
Publication restrictions are in place

Restriction type: OTHER