the Efficency and Safety of Stretta in GERD
the Efficency and Safety of the Endoscopic Radiofrequency Procedure in Gastroesophageal Reflux Diseases
1 other identifier
observational
60
1 country
1
Brief Summary
This study evaluated the efficency and safety of the endoscopic radiofrequency procedure(Stretta) in adult gastroesophageal patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2016
CompletedFirst Submitted
Initial submission to the registry
June 21, 2018
CompletedFirst Posted
Study publicly available on registry
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 13, 2018
July 1, 2018
4.9 years
June 21, 2018
July 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta 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]
Demeester Score
1 year
LES Pressure
1 year
Number of participants with treatment-related adverse events
1 month
Study Arms (1)
Stretta
Radio Frequency Ablation (RFA) using a Stretta device.
Interventions
Eligibility Criteria
Patients with refractory GERD symptoms, without major esophagus motility disorder and large hiatus hernia.
You may qualify if:
- Age \> 18 years
- Small hiatus hernia (\< 2-3 cm)
- Los Angeles Grade 'A' or 'B' Reflux Esophagitis or non erosive esophagitis
- LES pressure \<15 mm Hg
- PPI dependent / refractory GERD
- abnormal 24h esophagus pH-impedance monitoring
You may not qualify if:
- Age \< 18 years
- Large hiatus hernia (\> 3 cm)
- Los Angeles Grade 'C' or 'D' Reflux Esophagitis
- LES pressure \> 15 mm Hg
- Underlying coagulation disorder
- Previous Esophageal or Gastric surgery
- Pregnant
- major esophagus motility disorder according to Chicago v3.0
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gastroenterology department,Beijing Tong Ren Hospital, Capital Medical University.
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chuan Zhang, MD
Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 21, 2018
First Posted
July 2, 2018
Study Start
January 2, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
July 13, 2018
Record last verified: 2018-07