Stretta In Reflux Uncontrolled by IPP (SIRUP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01682265
First received: September 5, 2012
Last updated: April 11, 2014
Last verified: April 2014

September 5, 2012
April 11, 2014
March 2012
September 2016   (final data collection date for primary outcome measure)
Efficiency of the treatment 6 months post-procedure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Efficiency of the treatment 6 months post-procedure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Evaluate the efficiency of the treatment 6 months post-procedure according to the patient's answers to the 2 following items : IPP treatment taken more then 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
Complete list of historical versions of study NCT01682265 on ClinicalTrials.gov Archive Site
  • Effects on digestive symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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)
  • Effects on digestive symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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)
  • Necessity of IPP treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compare Stretta and sham procedure according to necessity of IPP treatment
  • necessity of IPP treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare Stretta and sham procedure according to necessity of IPP treatment
  • Tolerance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 24.
  • Tolerance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 48.
  • Quality of live [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compare Stretta and sham procedure according to Quality of life (use of quality of life questionaries)
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare Stretta and sham procedure according to Quality of life
  • pH-impedancemetry predictive factors [ Time Frame: At Inclusion ] [ Designated as safety issue: No ]
    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.
  • Efficiency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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
  • Efficiency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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
  • Effects on digestive symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compare Stretta and sham procedure according to complete relief of digestive symptoms (calculation based upon number of days without digestive symptoms)
  • Effects on digestive symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare Stretta and sham procedure according to complete relief of digestive symptoms
  • Necessity of IPP treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compare Stretta and sham procedure according to necessity of IPP treatment
  • necessity of IPP treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare Stretta and sham procedure according to necessity of IPP treatment
  • Tolerance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Compare Stretta and sham procedure according to Tolerance
  • Tolerance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Compare Stretta and sham procedure according to Tolerance
  • Quality of live [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compare Stretta and sham procedure according to Quality of life (use of quality of life questionaries)
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare Stretta and sham procedure according to Quality of life
  • PH impedancemetry predictive factors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine pH-impedancemetry predictive factors for positive response to stretta method
  • pH-impedancemetry predictive factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Determine pH-impedancemetry predictive factors for positive response to stretta method
  • Efficiency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluate efficiency of the stretta procedure in patients unsatisfied after the sham procedure at week 48
  • Efficiency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluate efficiency of the 2nd stretta procedure in patients unsatisfied after the 1st stretta procedure at week 48
Not Provided
Not Provided
 
Stretta In Reflux Uncontrolled by IPP
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.

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)

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • Other: Stretta procedure
    Other Name: Radiofrequency of esophagus
  • Other: Sham procedure
    No radiofrequency delivered
  • 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.

    Intervention: Other: Stretta procedure
  • 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.

    Intervention: Other: Sham procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2017
September 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Stanislas Bruley des Varannes, Professor +33 2.40.08.33.06 stanilas.bruleydesvarannes@chu-nantes.fr
France
 
NCT01682265
BRD 11/6-Q
Yes
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Stanislas Bruley des Varannes, Professor Nantes Universitary Hospital
Principal Investigator: Philippe Ducrotte, Professor Rouen Universitary Hospital
Principal Investigator: Thierry Ponchon, Professor Lyon Universitary Hospital
Principal Investigator: Franck Zerbib, Professor Bordeaux Universitary Hospital
Nantes University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP