Trial Outcomes & Findings for Radiofrequency Ablation for Patients With Esophageal Squamous Cell Neoplasia (NCT NCT02047305)
NCT ID: NCT02047305
Last Updated: 2020-05-21
Results Overview
The percentage of subjects demonstrating complete response (CR) defined as complete histological clearance of MGIN, HGIN and SCCA in the treatment area at 12 months after the initial ablation procedure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
12 Month
Results posted on
2020-05-21
Participant Flow
Participant milestones
| Measure |
Radiofrequency Ablation
To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN
Radiofrequency Ablation: Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals.
|
|---|---|
|
Overall Study
STARTED
|
96
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiofrequency Ablation for Patients With Esophageal Squamous Cell Neoplasia
Baseline characteristics by cohort
| Measure |
Radiofrequency Ablation
n=96 Participants
To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN
Radiofrequency Ablation: Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals.
|
|---|---|
|
Age, Customized
Age
|
59.9 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese Ethnicity
|
96 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
96 participants
n=5 Participants
|
|
Body Mass Index
|
23.4 (kg/m^2)
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Current Use of Tabacco
|
29 Participants
n=5 Participants
|
|
Current Use of Alcohol
|
32 Participants
n=5 Participants
|
|
History of Cancer
History of any cancer in a first-degree relative
|
29 Participants
n=5 Participants
|
|
History of Cancer
Esophageal cancer
|
15 Participants
n=5 Participants
|
|
Grade of esophageal neoplasia at study entry
MGIN
|
45 Participants
n=5 Participants
|
|
Grade of esophageal neoplasia at study entry
HGIN
|
42 Participants
n=5 Participants
|
|
Grade of esophageal neoplasia at study entry
T1m2 ESCC
|
9 Participants
n=5 Participants
|
|
Length of unstained lesions
|
6.5 CM
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Length of treatment area
|
8.6 CM
STANDARD_DEVIATION 2.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthThe percentage of subjects demonstrating complete response (CR) defined as complete histological clearance of MGIN, HGIN and SCCA in the treatment area at 12 months after the initial ablation procedure
Outcome measures
| Measure |
Radiofrequency Ablation
n=96 Participants
To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN
Radiofrequency Ablation: Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals.
|
|---|---|
|
Complete Response
|
81 Participants
|
Adverse Events
Radiofrequency Ablation
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Radiofrequency Ablation
n=96 participants at risk
To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN
Radiofrequency Ablation: Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals.
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|---|---|
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Surgical and medical procedures
Mucosal Lacerations
|
4.2%
4/96
|
|
Surgical and medical procedures
Mucosal Bleb
|
1.0%
1/96
|
|
Surgical and medical procedures
Stricture
|
20.8%
20/96
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place