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Radiofrequency Ablation for the Treatment of Gastric Dysplasia

NCT01523912 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-02-22

No results posted yet for this study

Summary

The finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment of dysplastic Barrett's esophagus, but its use in gastric dysplasia has not yet been studied. The investigators aim to study the efficacy, safety and tolerability of RFA in the treatment of dysplastic gastric mucosa.

Conditions

  • Gastric Dysplasia
  • Neoplasia

Interventions

DEVICE

Radiofrequency ablation of dysplastic mucosa (HALO)

Gastric ablation is performed using the HALO Ablation System (BÂRRX Medical Inc., Sunnyvale, CA, USA). A HALO90 ablation catheter, which is mounted on the tip of an endoscope, is used. Radiofrequency energy is delivered at 40 W/cm2 and 15 J/cm2 via a 13 x 20 mm electrode. All patients will have two RFA sessions 8 weeks apart with the same area being ablated in consecutive endoscopies. The precise area to ablated in the second RFA session is determined by referring to careful measurements that utilized gastric landmarks (a typical notation may specify that the lesion extends from 2 to 5 cm proximal of the pylorus in the 5 o'clock position and is 4 cm wide) as well as to digital image recordings that are taken during the first RFA.

Sponsors & Collaborators

  • Hospital Sao Joao

    lead OTHER

Principal Investigators

  • Francisco Baldaque-Silva, MD · Hospital Sao Joao

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-01-31
Completion
2015-05-31

Countries

  • Portugal

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 NCT01523912 on ClinicalTrials.gov