the Efficency and Safety of Stretta in GERD

Last updated: July 11, 2018
Sponsor: Capital Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03574831
xhnk001
  • Ages 18-80
  • All Genders

Study Summary

This study evaluated the efficency and safety of the endoscopic radiofrequency procedure(Stretta) in adult gastroesophageal patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age > 18 years

  2. Small hiatus hernia (< 2-3 cm)

  3. Los Angeles Grade 'A' or 'B' Reflux Esophagitis or non erosive esophagitis

  4. LES pressure ＜15 mm Hg

  5. PPI dependent / refractory GERD

  6. abnormal 24h esophagus pH-impedance monitoring

Exclusion

Exclusion Criteria:

  1. Age < 18 years

  2. Large hiatus hernia (> 3 cm)

  3. Los Angeles Grade 'C' or 'D' Reflux Esophagitis

  4. LES pressure > 15 mm Hg

  5. Underlying coagulation disorder

  6. Previous Esophageal or Gastric surgery

  7. Pregnant

  8. major esophagus motility disorder according to Chicago v3.0

Study Design

Total Participants: 60
Study Start date:
January 02, 2016
Estimated Completion Date:
December 01, 2021

Study Description

Gastro-esophageal reflux disease (GERD) is the most common outpatient diagnosis in gastroenterology and is associated with a significant burden on the healthcare system. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment,howerver, some patients have an unsatisfactory response to high doses of PPIs, which remains a challenge. The Stretta procedure, a radiofrequency (RF) application to the lower esophageal sphincter (LES), was introduced about 15 years ago as an alternative to chronic medical therapy or surgical intervention for GERD.The Stretta procedure appears to result in thickening of the LES, decreased transient LES relaxation rate and reduced esophageal acid exposure.The majority studies of Stretta were held in USA and Europe, the sduty of Stretta in Asia is rare. The investigators propose to perform a prospectively observiton study to evaluate the efficency of the Stretta procedure in patients of refractory GERD in China.

Connect with a study center

  • Gastroenterology department,Beijing Tong Ren Hospital, Capital Medical University.

    Beijing, Beijing 100000
    China

    Active - Recruiting

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