CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled
Drug / intervention
Radiofrequency Ablationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02047305
NCT02047305N/ACompleted
CompareCT.gov

A Single-center Trial of Endoscopic Radiofrequency Ablation of Moderate and High-grade Intra-epithelial Squamous Neoplasia and Early Flat-type Squamous Cell Carcinoma Using the HALO Ablation System

Covidien, GI Solutions·interventional·Posted Jan 28, 2014·Updated May 21, 2020

In Brief

A clinical study evaluating Radiofrequency Ablation for ESOPHAGEAL SQUAMOUS CELL CARCINOMA. Completed, enrolled 96 participants across 1 site.

Detailed Summary

Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsESOPHAGEAL SQUAMOUS CELL CARCINOMA
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2014
Enrollment StartJan 1, 2009
Primary CompletionAug 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 12.4 years ago

Interventions

Radiofrequency Ablationdevice

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.