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Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

NCT01614418 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-12-19

No results posted yet for this study

Summary

Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic surveillance, there is no other intervention which predictably eradicates pre-cancerous gastric lesions.

Endoscopic radiofrequency ablative (RFA) therapy has been recently shown to be highly effective in eradicating both IM and dysplasia in patients with Barrett's esophagus. However, the potential role of RFA to remove gastric IM and dysplasia remains unknown. In this study, we determine the feasibility of using endoscopic RFA in treating early gastric neoplasia (metaplasia and dysplasia). Patients with gastric metaplasia and/or dysplasia will be treated with endoscopic RFA. The safety and effects of RFA will be determined.

Conditions

  • Gastric Dysplasia
  • Intestinal Metaplasia

Interventions

DEVICE

Endoscopic radiofrequency ablation catheter

Endoscopic radiofrequency ablation

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Wai Keung Leung, MD · The University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01614418 on ClinicalTrials.gov