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Completed

NCT Number: NCT01682265

Stretta In Reflux Uncontrolled by IPP

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes Universitary Hospital, Nantes, Loire Atlantique, France

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stretta procedure

Other

Other names: Radiofrequency of esophagus

Sham Procedure

Other

No radiofrequency delivered

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Stretta In Reflux Uncontrolled by Intake of Inhibitors of Protons Pump (IPP).- The SIRUP Trial- Multicentric, Randomized, Double Blind, Prospective Study

Acronym: SIRUP

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 10, 2012
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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