Gastroesophageal Reflux DiseaseNCT03223116
Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease
A study testing Radiofrequency delivery in people with Gastroesophageal Reflux Disease, run by Changhai Hospital at 1 site in China.
Trial summary
This study is to evaluate the safety and efficacy of radiofrequency energy procedure for Gastro-esophageal reflux disease (GERD) based on changes of symptoms, medication esophagitis grade, esophageal acid exposure and lower esophageal sphincter pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Radiofrequency delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2015to 1 Jul 2018
- Phase
- Interventional
- 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
Who may be able to join
- age 18 years or older
- diagnosis of GERD established by either
- 24-h oesophageal pH monitoring (performed off medications) showing an abnormal OAE (pH < 4 at least 4% of time) and/or
- an upper gastrointestinal (GI) endoscopy showing oesophagitis grade A or B in Los Angeles (LA) classification
- presence of typical symptoms of GERD (heartburn and ⁄or regurgitation with at least three episodes of typical symptoms per week in the absence of PPI therapy),
- adequate symptom relief obtained with PPIs,but needing maintenance with at least standard dose.
Who cannot join
- presence of Barrett's oesophagus >3 cm and ⁄or with dysplasia and ⁄or previously treated,
- presence of hiatus hernia >3 cm,
- presence of oesophagitis grade C or D in LA classification,
- presence of oesophageal stricture or achalasia,
- history of oesophageal or gastric surgery,
- presence of gastric or oesophageal varices,
- impossibility to stop an anticoagulant therapy or severe coagulopathy,
- any contraindication to general anaesthesia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Departmentof Gastroenterology Changhai Hospital
Shanghai, Shanghai Municipality, 200433
luowei Wang, MD, 13901833088, wangluoweimd@126.com
peipei Liu, 15821692703, 15821692703@163.com
About this study
Official title: Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease: A Prospective, Multicenter Clinical Trial From China
This study is to evaluate the safety and efficacy of radiofrequency energy procedure for Gastro-esophageal reflux disease (GERD) based on changes of symptoms, medication esophagitis grade, esophageal acid exposure and lower esophageal sphincter pressure. Symptom assessment was performed at baseline and 3, 6, 12 months after treatment.
Read the detailed description
Gastroesophageal reflux disease (GERD) is a chronic disease characterized by symptoms of heartburn and acid regurgitation. Uncontrolled GERD can significantly impact quality of life. The use of proton pump inhibitors (PPI) remains the mainstay therapy. However, the efficacy of this intervention is often hampered by adherence, costs, and the risks of long-term PPI use. Anti-reflux surgery is an option for patients with refractory symptoms or in those in whom medical therapy is contraindicated or not desirable, but the incidence of dysphagia, abdominal distension associated wth the surgery is high. Radiofrequency ablation, minimally invasive, less complications, has become alternative treatments options. But the current research on radiofrequency treatment of the data is limited in China. Therefore, the investigators conduct this multi-center clinical trial.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Radiofrequency delivery
- Keywords
- heartburn, regurgitation
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency deliveryProcedure or surgery
Radiofrequency to the gastroesophageal junction
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency | Experimental | Radiofrequency delivery to the gastroesophageal junction Receives: Procedure: Radiofrequency delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline GERD-HRQL scores at 12 months
Assess the GERD-HRQL scores at 12 month and compare it with the baseline
Measured: 12 months
Secondary outcomes (4)
Change from baseline esophagitis grade at 12 months
Assess the esophagitis condition at 12 month and compare it with the baseline
Measured: 12 months
Change from baseline esophageal acid exposure times from at 12 months
Measure the esophageal acid exposure at 12 months and compare it with the baseline
Measured: 12 month
Change from baseline lower esophageal sphincter pressure at 12 months
Measure the lower esophageal sphincter pressure at 12 month and compare it with the baseline
Measured: 12 month
Change from baseline medication at 12 months
Assess dosage of the medication at 12 month and compare it with the baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Jul 2015
- Primary completion1 Sep 2017 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- zhaoshen Li, MD, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223116
- Sponsor's protocol ID
- CC2015
- Status last verified
- Jul 2017
- First submitted
- 30 Jun 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fock KM, Talley N, Goh KL, Sugano K, Katelaris P, Holtmann G, Pandolfino JE, Sharma P, Ang TL, Hongo M, Wu J, Chen M, Choi MG, Law NM, Sheu BS, Zhang J, Ho KY, Sollano J, Rani AA, Kositchaiwat C, Bhatia S. Asia-Pacific consensus on the management of gastro-oesophageal reflux disease: an update focusing on refractory reflux disease and Barrett's oesophagus. Gut. 2016 Sep;65(9):1402-15. doi: 10.1136/gutjnl-2016-311715. Epub 2016 Jun 3.
PubMed 27261337
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease: A Prospective, Multicenter Clinical Trial From China
- ClinicalTrials.gov ID
- NCT03223116
- Acronym / sponsor ID
- CC2015
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- heartburn, regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 19 Jul 2017 (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 is to evaluate the safety and efficacy of radiofrequency energy procedure for Gastro-esophageal reflux disease (GERD) based on changes of symptoms, medication esophagitis grade, esophageal acid exposure and lower esophageal sphincter pressure. Symptom assessment was performed at baseline and 3, 6, 12 months after treatment.
Detailed description
Gastroesophageal reflux disease (GERD) is a chronic disease characterized by symptoms of heartburn and acid regurgitation. Uncontrolled GERD can significantly impact quality of life. The use of proton pump inhibitors (PPI) remains the mainstay therapy. However, the efficacy of this intervention is often hampered by adherence, costs, and the risks of long-term PPI use. Anti-reflux surgery is an option for patients with refractory symptoms or in those in whom medical therapy is contraindicated or not desirable, but the incidence of dysphagia, abdominal distension associated wth the surgery is high. Radiofrequency ablation, minimally invasive, less complications, has become alternative treatments options. But the current research on radiofrequency treatment of the data is limited in China. Therefore, the investigators conduct this multi-center clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency | Experimental | Procedure: Radiofrequency deliveryRadiofrequency delivery to the gastroesophageal junction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 years or older
- diagnosis of GERD established by either
- presence of typical symptoms of GERD (heartburn and ⁄or regurgitation with at least three episodes of typical symptoms per week in the absence of PPI therapy),
- adequate symptom relief obtained with PPIs,but needing maintenance with at least standard dose.
Key exclusion criteria (8 listed)
- presence of Barrett's oesophagus >3 cm and ⁄or with dysplasia and ⁄or previously treated,
- presence of hiatus hernia >3 cm,
- presence of oesophagitis grade C or D in LA classification,
- presence of oesophageal stricture or achalasia,
- history of oesophageal or gastric surgery,
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 |
|---|---|---|
| Radiofrequency deliveryRadiofrequency to the gastroesophageal junction | Procedure or surgery | Radiofrequency |
Primary outcome
Change from Baseline GERD-HRQL scores at 12 months
Time frame: 12 months
Assess the GERD-HRQL scores at 12 month and compare it with the baseline
4 secondary outcomes
Change from baseline esophagitis grade at 12 months
Time frame: 12 months
Change from baseline esophageal acid exposure times from at 12 months
Time frame: 12 month
Change from baseline lower esophageal sphincter pressure at 12 months
Time frame: 12 month
Change from baseline medication at 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Background: PubMed 27261337Fock KM, Talley N, Goh KL, Sugano K, Katelaris P, Holtmann G, Pandolfino JE, Sharma P, Ang TL, Hongo M, Wu J, Chen M, Choi MG, Law NM, Sheu BS, Zhang J, Ho KY, Sollano J, Rani AA, Kositchaiwat C, Bhatia S. Asia-Pacific consensus on the management of gastro-oesophageal reflux disease: an update focusing on refractory reflux disease and Barrett's oesophagus. Gut. 2016 Sep;65(9):1402-15. doi: 10.1136/gutjnl-2016-311715. Epub 2016 Jun 3.
- 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.
zhaoshen Li, MD study chair
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency delivery in people with Gastroesophageal Reflux Disease, run by Changhai Hospital 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 19 Jul 2017. 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 luowei Wang, MD (13901833088, wangluoweimd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline GERD-HRQL scores at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03223116, which also lists 1 linked publication.
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 19 Jul 2017.