Gastroesophageal Reflux DiseaseNCT00200642
Evaluation of the Efficiency of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease
A study testing Stretta® System in people with Gastroesophageal Reflux Disease, run by Nantes University Hospital at 1 site in France.
Trial summary
Gastroesophageal reflux disease is a frequent disease and which heavily affects the patients' quality of life. To alleviate symptoms and ease the healing of lesion, patients very often need to continuously take anti-secretory drugs (Proton pump inhibitors or PPIs), which, despite their efficiency, do not cure the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Stretta® System
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2003to Oct 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient above 18 years old
- Suffering from typical symptoms of reflux (heartburn and/or acid regurgitation and/or epigastric burns with ascending radiations)
- Symptoms occurring at least 3 times a week without treatment
- Symptoms disappearing under full doses PPI treatment
- Requiring a continuous treatment for more than 3 months to get rid of symptoms (or nearly)
- Total consent signed from patient
Who cannot join
- Contraindications to the radiofrequency technique:
- Columnar lined oesophagus ³ 3 cm height
- Barret's mucosa presenting dysplasia
- History of treated columnar lined oesophagus
- Hiatus hernia with a size over 3 cm
- History of Stage C or D esophagitis in the Los Angeles classification (18), or in progress
Show all 18Show fewer
- History of oesophageal stenosis
- History of gastric or oesophageal surgery
- Presence of oesophageal and/or cardial varicose veins
- Presence of a cardiac pacemaker or implanted defibrillator (when confirmed by the manufacturer that use of RF energy will not interfere, it's ok to do patients!)
- Impossibility to interrupt a anticoagulant treatment or serious disorders of haemostasis
- General contraindications:
- Contraindication to general anaesthesia
- Existence of an associated serious disease making fear that the patient will live less than a year
- Incapacity to understand and sign a sensible consent of participation to the study
- Chronic alcoholism defined by a daily consumption of alcohol over 60 g
- Morbid obesity defined by a rate of body mass higher that 35
- Patients suffering from atypical GERD symptoms (especially extra-digestive) will not be included in the study if these symptoms are not associated with typical reflux symptoms (heartburn or regurgitation)
Trial locations and contacts
1 site in 1 country.
About this study
Gastroesophageal reflux disease is a frequent disease and which heavily affects the patients' quality of life. To alleviate symptoms and ease the healing of lesion, patients very often need to continuously take anti-secretory drugs (Proton pump inhibitors or PPIs), which, despite their efficiency, do not cure the disease. For these PPI dependent patients, an anti-reflux surgery (fundoplication often made by coelioscopy) is a possible alternative but it has a significant morbidity rate and even an estimated post-operative mortality of 0.8% outside of expertise centres. Therefore, new therapeutic endoscopic approaches, supposed to be less invasive and less expensive than surgery have been developed during the last three years. Among them, radiofrequency (Stretta® procedure) consists in administering a high frequency current in the cardia area, in order to induce thanks to a thermal effect a sub-mucous remodelling and a modification of the compliance of the cardia regionThe aim of this project carried out in 8 French centres and 2 European centers is to assess through a randomised trial, the efficiency of radiofrequency on PPI dependent patients. The study will be carried out in 2 phases with patients who have been fully informed of the project statement, and particularly of the potential risks of the radiofrequency technique and have given their written acceptation to participate to the study.The first phase, which will last 6 to 11 weeks, will aim at making sure that patients are PPI dependent and define their needs. After this initial phase, patients will be randomised between those who will carry on with the PPI treatment or the radiofrequency treatment. The follow up after this randomisation will last one year. The first assessment of the therapeutic efficiency will be done at 6th month. The 6 additional follow up months will be required for the assessment of mid-term side effects of the treatment and the rate of symptomatic recurrences.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Stretta® System
- Keywords
- Gastroesophageal reflux. PPI. Radiofrequency
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretta® SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The main endpoint will be the possibility or not to stop the PPI treatment (or to reduce the dose by at least 50%), 6 months after administering (or not) just one radiofrequency session.
Secondary outcomes (2)
The evaluation of tolerance,
the description of potential complications entailed by the technique and the measure of GERD recurrence rate on patients over a one-year period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2003
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jean Paul Galmiche, MD, Principal investigator, Nantes UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200642
- Sponsor's protocol ID
- BRD/03/6-F
- Status last verified
- May 2008
- First submitted
- 12 Sep 2005
- Last updated
- 22 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT00200642
- Acronym / sponsor ID
- BRD/03/6-F
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal reflux. PPI. Radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Oct 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- 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.
Gastroesophageal reflux disease is a frequent disease and which heavily affects the patients' quality of life. To alleviate symptoms and ease the healing of lesion, patients very often need to continuously take anti-secretory drugs (Proton pump inhibitors or PPIs), which, despite their efficiency, do not cure the disease. For these PPI dependent patients, an anti-reflux surgery (fundoplication often made by coelioscopy) is a possible alternative but it has a significant morbidity rate and even an estimated post-operative mortality of 0.8% outside of expertise centres. Therefore, new therapeutic endoscopic approaches, supposed to be less invasive and less expensive than surgery have been developed during the last three years. Among them, radiofrequency (Stretta® procedure) consists in administering a high frequency current in the cardia area, in order to induce thanks to a thermal effect a sub-mucous remodelling and a modification of the compliance of the cardia regionThe aim of this project carried out in 8 French centres and 2 European centers is to assess through a randomised trial, the efficiency of radiofrequency on PPI dependent patients. The study will be carried out in 2 phases with patients who have been fully informed of the project statement, and particularly of the potential risks of the radiofrequency technique and have given their written acceptation to participate to the study.The first phase, which will last 6 to 11 weeks, will aim at making sure that patients are PPI dependent and define their needs. After this initial phase, patients will be randomised between those who will carry on with the PPI treatment or the radiofrequency treatment. The follow up after this randomisation will last one year. The first assessment of the therapeutic efficiency will be done at 6th month. The 6 additional follow up months will be required for the assessment of mid-term side effects of the treatment and the rate of symptomatic recurrences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient above 18 years old
- Suffering from typical symptoms of reflux (heartburn and/or acid regurgitation and/or epigastric burns with ascending radiations)
- Symptoms occurring at least 3 times a week without treatment
- Symptoms disappearing under full doses PPI treatment
- Requiring a continuous treatment for more than 3 months to get rid of symptoms (or nearly)
Key exclusion criteria (18 listed)
- Contraindications to the radiofrequency technique:
- General contraindications:
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 |
|---|---|---|
| Stretta® System | Device | – |
Primary outcome
The main endpoint will be the possibility or not to stop the PPI treatment (or to reduce the dose by at least 50%), 6 months after administering (or not) just one radiofrequency session.
2 secondary outcomes
The evaluation of tolerance,
the description of potential complications entailed by the technique and the measure of GERD recurrence rate on patients over a one-year period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
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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.
Jean Paul Galmiche, MD principal investigator
Nantes UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretta® System in people with Gastroesophageal Reflux Disease, run by Nantes University Hospital at 1 site in France.
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 18 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: finished, as of the sponsor's last update on 22 May 2008. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main endpoint will be the possibility or not to stop the PPI treatment (or to reduce the dose by at least 50%), 6 months after administering (or not) just one radiofrequency session.. 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 22 May 2008.