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Stretta In Reflux Uncontrolled by IPP (SIRUP)

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ClinicalTrials.gov Identifier: NCT01682265
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Other: Stretta procedure Other: Sham procedure Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stretta In Reflux Uncontrolled by Intake of Inhibitors of Protons Pump (IPP).- The SIRUP Trial- Multicentric, Randomized, Double Blind, Prospective Study
Actual Study Start Date : March 26, 2012
Actual Primary Completion Date : November 27, 2018
Actual Study Completion Date : November 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Stretta procedure

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.

Other: Stretta procedure
Other Name: Radiofrequency of esophagus

Sham Comparator: Sham procedure

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.

Other: Sham procedure
No radiofrequency delivered




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Effects on digestive symptoms [ Time Frame: 6 months ]
    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)

  2. Effects on digestive symptoms [ Time Frame: 1 year ]
    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)

  3. Necessity of IPP treatment [ Time Frame: 6 months ]
    Compare Stretta and sham procedure according to necessity of IPP treatment

  4. necessity of IPP treatment [ Time Frame: 1 year ]
    Compare Stretta and sham procedure according to necessity of IPP treatment

  5. Tolerance [ Time Frame: 6 months ]
    Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 24.

  6. Tolerance [ Time Frame: 1 year ]
    Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 48.

  7. Quality of live [ Time Frame: 6 months ]
    Compare Stretta and sham procedure according to Quality of life (use of quality of life questionaries)

  8. Quality of life [ Time Frame: 1 year ]
    Compare Stretta and sham procedure according to Quality of life

  9. pH-impedancemetry predictive factors [ Time Frame: At Inclusion ]
    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.

  10. Efficiency [ Time Frame: 1 year ]
    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

  11. Efficiency [ Time Frame: 1 year ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 ans
  • Severe or moderate heartburn (at least 3 heartburn times per week), persistent under treatment with IPP

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682265


Locations
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France
Nantes Universitary Hospital
Nantes, Loire Atlantique, France, 44093
Bordeaux Universitary Hospital
Bordeaux, France
Brest universitary hospital
Brest, France, 29200
APHP - Louis Mourier hospital
Colombes, France, 92700
Lyon Universitary Hospital
Lyon, France, 69000
Rouen Universitary Hospital
Rouen, France, 76000
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Stanislas Bruley des Varannes, Professor Nantes Universitary Hospital
Principal Investigator: Chloe Melchior, Doctor Rouen Universitary Hospital
Principal Investigator: Thierry Ponchon, Professor Lyon Universitary Hospital
Principal Investigator: Franck Zerbib, Professor Bordeaux Universitary Hospital
Principal Investigator: Franck Cholet, Doctor Brest Universitary hospital
Principal Investigator: Benoit Coffin, Professor APHP-Louis Mourier hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01682265     History of Changes
Other Study ID Numbers: BRD/11/06-Q
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases