GERDNCT03574831
the Efficency and Safety of Stretta in GERD
An observational study of GERD and Radiofrequency Ablation, run by Capital Medical University at 1 site in China.
Trial summary
This study evaluated the efficency and safety of the endoscopic radiofrequency procedure(Stretta) in adult gastroesophageal patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GERD, Radiofrequency Ablation
- What is being tested?
- Stretta
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2016to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with refractory GERD symptoms, without major esophagus motility disorder and large hiatus hernia.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Gastroenterology department,Beijing Tong Ren Hospital, Capital Medical University.
Beijing, Beijing Municipality, 100000
Hao Zi Guo, MD, 86+15801227696, zihaoguo@139.com
About this study
Official title: the Efficency and Safety of the Endoscopic Radiofrequency Procedure in Gastroesophageal Reflux Diseases
This study evaluated the efficency and safety of the endoscopic radiofrequency procedure(Stretta) in adult gastroesophageal patients.
Read the detailed 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.
- Conditions
- GERD, Radiofrequency Ablation
- Being tested
- Stretta
- Keywords
- GERD, Radiofrequency ablation, efficiency, safety
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrettaDevice
Stretta
| Study group | Role | What they receive |
|---|---|---|
| Stretta | Radio Frequency Ablation (RFA) using a Stretta device. Receives: Device: Stretta |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD-HRQL scores
the improvement of GERD-HRQL scores after procedure.Scale ranges 0-50 points, the lower score means the better efficacy.
Measured: [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
Questionnaire will be provided to each participant to report no further requirement of PPI drug post procedure.
Measured: 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
the change of Demeester scores after procedure. The lower, the better.
Measured: 1 year
LES Pressure
the change of LES pressure after procedure.The higher, the better.
Measured: 1 year
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start2 Jan 2016
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Zihao, Capital Medical University
- Investigators
- Chuan Zhang, MD, Study chair, Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574831
- Sponsor's protocol ID
- xhnk001
- Status last verified
- Jul 2018
- First submitted
- 21 Jun 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Efficency and Safety of the Endoscopic Radiofrequency Procedure in Gastroesophageal Reflux Diseases
- ClinicalTrials.gov ID
- NCT03574831
- Acronym / sponsor ID
- xhnk001
- Conditions
- GERD, Radiofrequency Ablation
- Keywords
- GERD, Radiofrequency ablation, efficiency, safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the efficency and safety of the endoscopic radiofrequency procedure(Stretta) in adult gastroesophageal patients.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stretta | – | Device: StrettaRadio Frequency Ablation (RFA) using a Stretta device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory GERD symptoms, without major esophagus motility disorder and large hiatus hernia.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Age < 18 years
- Large hiatus hernia (> 3 cm)
- Los Angeles Grade 'C' or 'D' Reflux Esophagitis
- LES pressure > 15 mm Hg
- Underlying coagulation disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StrettaStretta | Device | Stretta |
Primary outcome
GERD-HRQL scores
Time frame: [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]
the improvement of GERD-HRQL scores after procedure.Scale ranges 0-50 points, the lower score means the better efficacy.
4 secondary outcomes
Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure
Time frame: 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
Time frame: 1 year
LES Pressure
Time frame: 1 year
Number of participants with treatment-related adverse events
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuan Zhang, MD study chair
Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD and Radiofrequency Ablation, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Zi Guo, MD (86+15801227696, zihaoguo@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GERD-HRQL scores (time frame: [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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.