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Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastric Dysplasia, Intestinal Metaplasia

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Trial Information

Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia


Inclusion Criteria:



1. Histological confirmation of gastric IM or dysplasia.

2. The lesion is no larger than 5 cm in diameter.

3. Age ≥ 18 years.

4. No previous endoscopic mucosal resection or submucosal dissection.

5. No active H. pylori infection.

6. Subject is able to tolerate endoscopy and sedation.

7. Subject agrees to participate, fully understands content of the informed consent, and
signs the informed consent form.

Exclusion Criteria:

1. Gastric cancer (intra-mucosal cancer or worse).

2. Prior gastric irradiation or surgery.

3. Anti-platelet or anti-thrombotic medication use that cannot be stopped for 7 days
before and after RFA.

4. Gastric ulcers, fistulae and varices.

5. History of alcohol and/or controlled substance dependency.

6. Pregnancy.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Histological clearance of dysplasia/metaplasia

Outcome Time Frame:

6 month

Safety Issue:

No

Principal Investigator

Wai Keung Leung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Hong Kong

Authority:

Hong Kong: Ethics Committee

Study ID:

HKU_WKL_RFA1

NCT ID:

NCT01614418

Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Gastric Dysplasia
  • Intestinal Metaplasia
  • Metaplasia
  • Hyperplasia

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