the Efficency and Safety of Stretta in GERD

GERD Clinical Trial

Official title:

the Efficency and Safety of the Endoscopic Radiofrequency Procedure in Gastroesophageal Reflux Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03574831
• Other study ID #: xhnk001
• Status: Recruiting
• Start date: January 2, 2016
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2018
• Source: Capital Medical University
• Contact: Hao Zi Guo, MD
• Phone: 86+15801227696
• Email: zihaoguo[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 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

Related Conditions & MeSH terms

• GERD
• Radiofrequency Ablation

Intervention

Device:
• Stretta
Stretta

Locations

Country	Name	City	State
China	Gastroenterology department,Beijing Tong Ren Hospital, Capital Medical University.	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GERD-HRQL scores	the improvement of GERD-HRQL scores after procedure.Scale ranges 0-50 points, the lower score means the better efficacy.	[Time Frame: Change from Baseline HRQL scores at 1 month;Change from Baseline HRQL scores at 2 months;Change from Baseline HRQL scores at 6 months;Change from Baseline HRQL scores at 1 year]
Secondary	Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure	Questionnaire will be provided to each participant to report no further requirement of PPI drug post procedure.	Change from Baseline number at 1 month;Change from Baseline number at 2 months;Change from Baseline number at 6 months;Change from Baseline number at 1 year]
Secondary	Demeester Score	the change of Demeester scores after procedure. The lower, the better.	1 year
Secondary	LES Pressure	the change of LES pressure after procedure.The higher, the better.	1 year
Secondary	Number of participants with treatment-related adverse events	Number of participants with treatment-related adverse events	1 month