Gastroesophageal Reflux DiseaseSIRUPNCT01682265
Stretta In Reflux Uncontrolled by IPP
A study testing Stretta procedure in people with Gastroesophageal Reflux Disease, run by Nantes University Hospital at 6 sites in France.
Trial summary
The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency 6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP) patients. 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 procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 6 sitesFrance
- Study dates
- 26 Mar 2012to 27 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 ans
- Severe or moderate heartburn (at least 3 heartburn times per week), persistent under treatment with IPP
Who cannot join
- Recent oeso-gastro-duodenal endoscopy(< 3 months)
- Oesophagitis > grade A
- Endobrachyoesophagus > C0M1
- Hiatal Hernia > 2 cm
- Symptoms insufficiently relieved with continued intake of IPP or with intake of IPP according to needs
- Predominant symptom of Gastrooesophageal reflux disease other than heartburn
- Patients contra-indicated for radiofrequency technique
- Pregnant women
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Bordeaux Universitary Hospital
Bordeaux
Brest universitary hospital
Brest, 29200
APHP - Louis Mourier hospital
Colombes, 92700
Lyon Universitary Hospital
Lyon, 69000
Nantes Universitary Hospital
Nantes, Loire Atlantique, 44093
Rouen Universitary Hospital
Rouen, 76000
About this study
Official title: Stretta In Reflux Uncontrolled by Intake of Inhibitors of Protons Pump (IPP).- The SIRUP Trial- Multicentric, Randomized, Double Blind, Prospective Study
The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency 6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP) patients.
Read the detailed description
The study is over a period of 1 year. After checking eligibility, the patient will be randomised in double blind : stretta procedure /sham procedure. Control visits will take place after 4 weeks (on site), 8 weeks (by phone), 12 weeks (by phone), 18 weeks(on site) and 24 weeks(on site).During the 24 weeks visit, the therapeutic success will be evaluated.
In case of success, endoscopic control will be performed and the patient will come back on site at week 36 and 48 (end of study). In case of therapeutic failure, the stretta procedure will be proposed to the patient without breaking the blind for the 1st procedure. The procedure will be scheduled between week 24 and week 27. The patient will come back for a visit on site at weeks 31, 36 and 48 (end of visit)
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Stretta procedure, Sham procedure
- 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 procedureOther
Also called Radiofrequency of esophagus
Sham procedureOther
No radiofrequency delivered
| Study group | Role | What they receive |
|---|---|---|
| Stretta procedure | Experimental | Patient randomized in Stretta procedure arm will be hospitalized to have endoscopy and esophagus will receive radiofrequency.
Control visits will then take place until Month 6. At this visit endoscopic control will take place. Receives: Other: Stretta procedure |
| Sham procedure | Sham comparator | Patient randomized in Sham procedure arm will be hospitalized to have endoscopy. Material necessary to perform Stretta procedure will be inserted (like in Stretta procedure arm) BUT esophagus will not receive radiofrequency.
Control visits will then take place until Month 6. At this visit endoscopic control will take place. Receives: Other: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of the treatment 6 months post-procedure
Evaluate the efficiency of the treatment 6 months post-procedure according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 24
Measured: 6 months
Secondary outcomes (11)
Effects on digestive symptoms
Compare Stretta and sham procedure according to complete relief of digestive symptoms and pyrosis (calculation based upon number of days without digestive symptoms and pyrosis as indicated by the patient on a questionary completed during the 2 weeks preceding visits à 6 months)
Measured: 6 months
Effects on digestive symptoms
Compare Stretta and sham procedure according to complete relief of digestive symptoms and pyrosis (calculation based upon number of days without digestive symptoms and pyrosis as indicated by the patient on a questionary completed during the 2 weeks preceding visits à 12 months)
Measured: 1 year
Necessity of IPP treatment
Compare Stretta and sham procedure according to necessity of IPP treatment
Measured: 6 months
necessity of IPP treatment
Compare Stretta and sham procedure according to necessity of IPP treatment
Measured: 1 year
Tolerance
Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 24.
Measured: 6 months
Tolerance
Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 48.
Measured: 1 year
Quality of live
Compare Stretta and sham procedure according to Quality of life (use of quality of life questionaries)
Measured: 6 months
Quality of life
Compare Stretta and sham procedure according to Quality of life
Measured: 1 year
pH-impedancemetry predictive factors
pH-impedancemetry will be realized at clinical trial start, when patient is under PPI intake to determine pH-impedancemetry predictive factors for positive response to stretta method. Acid and non acid exposition of the esophagus will be measured as well as the SAP (Symptom Association Probability) which corresponds to the probability of association between symptoms felt by the patient during the pH-impedancemetry and episodes of acid or non acid reflux.
Measured: At Inclusion
Efficiency
Evaluate efficiency of the stretta procedure in patients unsatisfied after the sham procedure at week 48 according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 48
Measured: 1 year
Efficiency
Evaluate efficiency of the 2nd stretta procedure in patients unsatisfied after the 1st stretta procedure at week 48 according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 48
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study start26 Mar 2012
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanislas Bruley des Varannes, Professor, Principal investigator, Nantes Universitary HospitalChloe Melchior, Doctor, Principal investigator, Rouen Universitary HospitalThierry Ponchon, Professor, Principal investigator, Lyon Universitary HospitalFranck Zerbib, Professor, Principal investigator, Bordeaux Universitary HospitalFranck Cholet, Doctor, Principal investigator, Brest Universitary hospitalBenoit Coffin, Professor, Principal investigator, APHP-Louis Mourier hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682265
- Sponsor's protocol ID
- BRD/11/06-Q
- Acronym
- SIRUP
- Status last verified
- Jan 2019
- First submitted
- 5 Sep 2012
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zerbib F, Sacher-Huvelin S, Coron E, Coffin B, Melchior C, Ponchon T, Cholet F, Chabrun E, Vavasseur F, Gorbatchef C, Zalar A, Mion F, Robaszkiewicz M, Le Rhun M, Leroy M, Paul Galmiche J, Bruley des Varannes S. Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn. Aliment Pharmacol Ther. 2020 Aug;52(4):637-645. doi: 10.1111/apt.15936. Epub 2020 Jul 13.
PubMed 32656869
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stretta In Reflux Uncontrolled by Intake of Inhibitors of Protons Pump (IPP).- The SIRUP Trial- Multicentric, Randomized, Double Blind, Prospective Study
- ClinicalTrials.gov ID
- NCT01682265
- Acronym / sponsor ID
- SIRUP / BRD/11/06-Q
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 26 Mar 2012 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 10 Sep 2012 (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.
The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency 6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP) patients.
Detailed description
The study is over a period of 1 year. After checking eligibility, the patient will be randomised in double blind : stretta procedure /sham procedure. Control visits will take place after 4 weeks (on site), 8 weeks (by phone), 12 weeks (by phone), 18 weeks(on site) and 24 weeks(on site).During the 24 weeks visit, the therapeutic success will be evaluated.
In case of success, endoscopic control will be performed and the patient will come back on site at week 36 and 48 (end of study). In case of therapeutic failure, the stretta procedure will be proposed to the patient without breaking the blind for the 1st procedure. The procedure will be scheduled between week 24 and week 27. The patient will come back for a visit on site at weeks 31, 36 and 48 (end of visit)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretta procedure | Experimental | Other: Stretta procedurePatient randomized in Stretta procedure arm will be hospitalized to have endoscopy and esophagus will receive radiofrequency. Control visits will then take place until Month 6. At this visit endoscopic control will take place. |
| Sham procedure | Sham comparator | Other: Sham procedurePatient randomized in Sham procedure arm will be hospitalized to have endoscopy. Material necessary to perform Stretta procedure will be inserted (like in Stretta procedure arm) BUT esophagus will not receive radiofrequency. Control visits will then take place until Month 6. At this visit endoscopic control will take place. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 ans
- Severe or moderate heartburn (at least 3 heartburn times per week), persistent under treatment with IPP
Key exclusion criteria (8 listed)
- Recent oeso-gastro-duodenal endoscopy(< 3 months)
- Oesophagitis > grade A
- Endobrachyoesophagus > C0M1
- Hiatal Hernia > 2 cm
- Symptoms insufficiently relieved with continued intake of IPP or with intake of IPP according to needs
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 procedureAlso: Radiofrequency of esophagus | Other | Stretta procedure |
| Sham procedureNo radiofrequency delivered | Other | Sham procedure |
Primary outcome
Efficiency of the treatment 6 months post-procedure
Time frame: 6 months
Evaluate the efficiency of the treatment 6 months post-procedure according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 24
11 secondary outcomes
Effects on digestive symptoms
Time frame: 6 months
Effects on digestive symptoms
Time frame: 1 year
Necessity of IPP treatment
Time frame: 6 months
necessity of IPP treatment
Time frame: 1 year
Tolerance
Time frame: 6 months
Tolerance
Time frame: 1 year
Quality of live
Time frame: 6 months
Quality of life
Time frame: 1 year
pH-impedancemetry predictive factors
Time frame: At Inclusion
Efficiency
Time frame: 1 year
Efficiency
Time frame: 1 year
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 14 Sep 2026.
- Results publication: PubMed 32656869Zerbib F, Sacher-Huvelin S, Coron E, Coffin B, Melchior C, Ponchon T, Cholet F, Chabrun E, Vavasseur F, Gorbatchef C, Zalar A, Mion F, Robaszkiewicz M, Le Rhun M, Leroy M, Paul Galmiche J, Bruley des Varannes S. Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn. Aliment Pharmacol Ther. 2020 Aug;52(4):637-645. doi: 10.1111/apt.15936. Epub 2020 Jul 13.
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Not yet recruitingObservational study
Gastroesophageal Reflux and Respiratory Function in Patients Undergoing Abdominoplasty
Abdominoplasty, Diaphragm
Not yet recruiting
De Novo Gastroesophageal Reflux Disease After Sleeve Gastrectomy With and Without Omentopexy
Omentopexy, Sleeve Gastrectomy
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.
Stanislas Bruley des Varannes, Professor principal investigator
Nantes Universitary Hospital
Chloe Melchior, Doctor principal investigator
Rouen Universitary Hospital
Thierry Ponchon, Professor principal investigator
Lyon Universitary Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretta procedure in people with Gastroesophageal Reflux Disease, run by Nantes University Hospital at 6 sites 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 2 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. 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?
Efficiency of the treatment 6 months post-procedure (time frame: 6 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 NCT01682265, 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 14 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.