Radiofrequency Ablation for the Treatment of Gastric Dysplasia

NCT01523912 | Completed Phase 4

• 2 other identifiers: gastric ablationSG.HSJ.FMUP.01.2012
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

radiofrequency ablation; gastric dysplasia; gastric neoplasia

Outcome Measures

Primary Outcomes (1)

• The % of patients with complete histological clearance of dysplasia.

  12 months

Secondary Outcomes (2)

• Histological clearance of intestinal metaplasia

  12 months

• Adverse event incidence

  60 days

Study Arms (1)

gastric RFA

EXPERIMENTAL

Ablation of gastric dysplastic mucosa

Device: Radiofrequency ablation of dysplastic mucosa (HALO)

Interventions

Radiofrequency ablation of dysplastic mucosa (HALO) DEVICE

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.

Also known as: Halo, RFA

gastric RFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of gastric dysplasia.
• The lesion is no larger than 5 cm in diameter.
• Age ≥ 18 years.
• Subject is able to tolerate endoscopy and sedation.
• Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form.

You may not qualify if:

• Prior gastric irradiation or surgery.
• Anti-platelet or anti-thrombotic medication use that can not be stopped for 7 days before and after RFA.
• Gastric ulcers, fistulae, varices and malignancy.
• History of alcohol and/or controlled substance dependency.
• Pregnancy.

Sponsors & Collaborators

• Hospital Sao Joao: lead

Study Sites (1)

Gastroenterology Department, Hospital de Sao Joao

Porto, Portugal

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Francisco Baldaque-Silva, MD

  Hospital Sao Joao

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: February 1, 2012
• Study Start: January 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

PT (1)