Esophagus DisorderRAGENCT03518905
Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa
A study testing Radiofrequency ablation and esophagoscopy in people with Esophagus Disorder, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The heterotopic gastric mucosa found in the cervical esophagus was first described in 1805 and affects 10-15% of individuals undergoing esophagogastroduodenoscopy. It leads to laryngopharyngeal reflux (LPR), which causes symptoms like globus sensation, hoarseness and chronic cough. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophagus Disorder
- What is being tested?
- Radiofrequency ablation and esophagoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteAustria
- Study dates
- 16 Apr 2018to 16 Dec 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proven presence of heterotopic gastric mucosa,
- pathologic Reflux Symptom Index (>25)
- age: 18-70
- presence of symptoms > 6 months,
- no effect on the Reflux Symptom Index to 12 weeks of standard dose proton pump inhibitor treatment
- negative symptom correlation for symptoms with reflux events in ambulatory pH monitoring
Who cannot join
- Not willing to participate in this study
- pregnancy
- lactation period
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Ivan Kristo, MD, +434040056210, ivan.kristo@meduniwien.ac.at
About this study
Official title: Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa - a Prospective Randomized Sham-controlled Trial - the RAGE Study
The heterotopic gastric mucosa found in the cervical esophagus was first described in 1805 and affects 10-15% of individuals undergoing esophagogastroduodenoscopy. It leads to laryngopharyngeal reflux (LPR), which causes symptoms like globus sensation, hoarseness and chronic cough. The Reflux Symptom Index (RSI) that ranges from 0-45 measures LPR. Scores greater than 13 are considered to be pathologic. Currently, patients that suffer from symptoms of LPR and present with a heterotopic gastric mucosa are routinely offered radiofrequency ablation (RFA) as curative treatment. Up to now, around 40 patients were already treated at the department of Surgery with 90% histologic eradication rates after 2 treatment sessions and no reported serious adverse event. Nevertheless, the placebo effect could also be responsible for perception of improving symptoms. Therefore, this prospective sham-controlled trial was designed to exclude the placebo effect. As the device is already approved and routinely used for focal ablation safety data are already available. Up to now, there were no major adverse events, whereas only 10% of patients describe a sensation of irritated throat that dissolves within the first three days after treatment.
- Conditions
- Esophagus Disorder
- Being tested
- Radiofrequency ablation, esophagoscopy
- Medical subject headings
- Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationDevice
Radiofrequency ablation is performed using the Barrx Channel endoscopic catheter (Medtronic, Dublin, Republic of Ireland) generating an energy density level of 12 Joule/cm2. The energy is applied using a simplified protocol of three ablations without removal of coagulated tissue. The device is used on a routinely basis all around the world and already approved. The ablation catheter is applied through the working channel of the endoscope.
esophagoscopyProcedure or surgery
Patients receive an esophagoscopy without radiofrequency ablation under sedation
| Study group | Role | What they receive |
|---|---|---|
| sham-treatment | Sham comparator | Patients with symptomatic large heterotopic gastric mucosa receive an esophagoscopy without radiofrequency ablation under sedation Receives: Procedure: esophagoscopy |
| treatment arm | Active comparator | Patients with symptomatic large hetertotopic gastric mucosa receive an esophagoscopy with radiofrequency ablation (12J/cm2) using the Barrx channel RFA endoscopic catheter (Medtronic) Receives: Device: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of the Reflux Symptom Index
Normalization of the Reflux Symptom Index (RSI <14) after two treatment/sham sessions evaluated 3 months after the second (sham-) treatment (therefore 6 months after the first endoscopy with/without RFA). Proton-pump inhibitors are paused 8 weeks before assessment
Measured: 6 months after first RFA treatment/or sham procedure
Secondary outcomes (3)
Histological eradication rate after radiofrequency ablation or sham treatment
Histologic eradication rate after RFA treatment/sham procedure measured after finalization of RFA (normalization of Reflux Symptom Index/or a maximum of two treatment sessions) or at the time of second sham treatment.
Measured: 6 months after first RFA treatment/or sham procedure
SF-12 quality of life
Measured: At enrollment (therefore before ablations or sham treatment) and 6 months after first radiofrequency ablation/sham treatment
Reflux Finding Score
the Reflux Finding Score is measured by using laryngofibroscopy to document potential absence of laryngopharyngeal reflux. The reflux finding score (RFS) represents an objective and validated instrument to analyze physical findings and severity of laryngopharyngeal reflux. An 8-item checklist with excellent inter-observer reliability grades abnormalities documented during laryngoscopy from 0-26 points. The total score is reported and summed from an 8 item checklist providing 0-4 points. Statistically, total scores greater than 7 have a likelihood of 95% to reflect LPR. Higher scores represent worse outcomes.
Measured: Evaluated at the first intervention at study completion after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start16 Apr 2018
- Primary completion16 Sep 2020 (estimated)
- Study completion16 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Model description
- randomized sham-controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ivan Kristo, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518905
- Sponsor's protocol ID
- 1340/2017
- Acronym
- RAGE
- Status last verified
- Feb 2020
- First submitted
- 15 Apr 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa - a Prospective Randomized Sham-controlled Trial - the RAGE Study
- ClinicalTrials.gov ID
- NCT03518905
- Acronym / sponsor ID
- RAGE / 1340/2017
- Conditions
- Esophagus Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 16 Sep 2020 (estimated)
- Study completion
- 16 Dec 2020 (estimated)
- First posted
- 8 May 2018 (actual)
- 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 heterotopic gastric mucosa found in the cervical esophagus was first described in 1805 and affects 10-15% of individuals undergoing esophagogastroduodenoscopy. It leads to laryngopharyngeal reflux (LPR), which causes symptoms like globus sensation, hoarseness and chronic cough. The Reflux Symptom Index (RSI) that ranges from 0-45 measures LPR. Scores greater than 13 are considered to be pathologic. Currently, patients that suffer from symptoms of LPR and present with a heterotopic gastric mucosa are routinely offered radiofrequency ablation (RFA) as curative treatment. Up to now, around 40 patients were already treated at the department of Surgery with 90% histologic eradication rates after 2 treatment sessions and no reported serious adverse event. Nevertheless, the placebo effect could also be responsible for perception of improving symptoms. Therefore, this prospective sham-controlled trial was designed to exclude the placebo effect. As the device is already approved and routinely used for focal ablation safety data are already available. Up to now, there were no major adverse events, whereas only 10% of patients describe a sensation of irritated throat that dissolves within the first three days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized sham-controlled
| Arm | Type | Receives |
|---|---|---|
| sham-treatment | Sham comparator | Procedure: esophagoscopyPatients with symptomatic large heterotopic gastric mucosa receive an esophagoscopy without radiofrequency ablation under sedation |
| treatment arm | Active comparator | Device: Radiofrequency ablationPatients with symptomatic large hetertotopic gastric mucosa receive an esophagoscopy with radiofrequency ablation (12J/cm2) using the Barrx channel RFA endoscopic catheter (Medtronic) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological proven presence of heterotopic gastric mucosa,
- pathologic Reflux Symptom Index (>25)
- age: 18-70
- presence of symptoms > 6 months,
- no effect on the Reflux Symptom Index to 12 weeks of standard dose proton pump inhibitor treatment
Key exclusion criteria (3 listed)
- Not willing to participate in this study
- pregnancy
- lactation period
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 |
|---|---|---|
| Radiofrequency ablationRadiofrequency ablation is performed using the Barrx Channel endoscopic catheter (Medtronic, Dublin, Republic of Ireland) generating an energy density level of 12 Joule/cm2. The energy is applied using a simplified protocol of three ablations without removal of coagulated tissue. The device is used on a routinely basis all around the world and already approved. The ablation catheter is applied through the working channel of the endoscope. | Device | treatment arm |
| esophagoscopyPatients receive an esophagoscopy without radiofrequency ablation under sedation | Procedure or surgery | sham-treatment |
Primary outcome
Normalization of the Reflux Symptom Index
Time frame: 6 months after first RFA treatment/or sham procedure
Normalization of the Reflux Symptom Index (RSI <14) after two treatment/sham sessions evaluated 3 months after the second (sham-) treatment (therefore 6 months after the first endoscopy with/without RFA). Proton-pump inhibitors are paused 8 weeks before assessment
3 secondary outcomes
Histological eradication rate after radiofrequency ablation or sham treatment
Time frame: 6 months after first RFA treatment/or sham procedure
SF-12 quality of life
Time frame: At enrollment (therefore before ablations or sham treatment) and 6 months after first radiofrequency ablation/sham treatment
Reflux Finding Score
Time frame: Evaluated at the first intervention at study completion after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation and esophagoscopy in people with Esophagus Disorder, run by Medical University of Vienna at 1 site in Austria.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivan Kristo, MD (+43140 40056210, ivan.kristo@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalization of the Reflux Symptom Index (time frame: 6 months after first RFA treatment/or sham procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2020.