NCT01682265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

6.7 years

First QC Date

September 5, 2012

Last Update Submit

January 28, 2019

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (11)

  • Effects on digestive symptoms

    6 months

  • Effects on digestive symptoms

    1 year

  • Necessity of IPP treatment

    6 months

  • necessity of IPP treatment

    1 year

  • Tolerance

    6 months

  • +6 more secondary outcomes

Study Arms (2)

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.

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.

Other: Sham procedure

Interventions

Stretta procedureOTHER
Also known as: Radiofrequency of esophagus
Stretta procedure
Sham procedureOTHER

No radiofrequency delivered

Sham procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Nantes Universitary Hospital

Nantes, Loire Atlantique, 44093, France

Location

Bordeaux Universitary Hospital

Bordeaux, France

Location

Brest universitary hospital

Brest, 29200, France

Location

APHP - Louis Mourier hospital

Colombes, 92700, France

Location

Lyon Universitary Hospital

Lyon, 69000, France

Location

Rouen Universitary Hospital

Rouen, 76000, France

Location

Related Publications (1)

  • 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.

    PMID: 32656869DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 10, 2012

Study Start

March 26, 2012

Primary Completion

November 27, 2018

Study Completion

November 27, 2018

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

FR(6)