Barrett EsophagusNCT03471052
Radiofrequency Ablation vs Sham Procedure for Symptomatic Cervical Inlet Patch
A study testing Radiofrequency ablation (RFA) in people with Barrett Esophagus, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Inlet patch is a congenital condition of the upper oesophagus, consisting of stomach lining that is in the wrong place. It affects 5% of the population. Symptoms are a feeling of a ball in the back of the throat (called chronic globus sensation), cough and sore throat - these account for 4% of general practitioner… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Radiofrequency ablation (RFA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2018to 30 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptoms secondary to Inlet patch and globus score > 50 on Visual Analogue Scale (VAS)
- Histological confirmation of presence of Inlet patch
- Symptoms not responsive or partially responsive to (proton pump inhibitor) PPI therapy for > = 6 weeks
- Males and non-pregnant females over the age of 18 years. Female patients who are pre-menopausal must practice a medically acceptable form of contraception.
- Patients must sign an informed consent form.
Who cannot join
- Patients in whom endoscopy is contraindicated.
- No globus symptoms
- Patients previously or currently treated for oesophageal dysplasia or cancer
- Patients with eosinophilic oesophagitis
- Patients with oesophageal varices
- Previous radiotherapy
Show all 11Show fewer
- Patients who have undergone Hellers myotomy
- Pregnant females.
- People under the age of 18 years.
- Evidence of major motility disorder on High resolution Manometry
- Patients with pre-existing ENT disorders causing globus.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Jason Dunn, GMSresearch@gstt.nhs.uk
Dr J Dunn
About this study
Official title: Randomised Controlled Trial of Radiofrequency Ablation Versus a Sham Procedure for Symptomatic Cervical Inlet Patch
Inlet patch is a congenital condition of the upper oesophagus, consisting of stomach lining that is in the wrong place. It affects 5% of the population. Symptoms are a feeling of a ball in the back of the throat (called chronic globus sensation), cough and sore throat - these account for 4% of general practitioner (GP) referral to Ear Nose \& Throat departments.
There is no recognised treatment. Drugs that reduce acid may help but do not block mucus production. Argon Plasma coagulation has been shown to be successful but limited to a few expert centres. The investigators have previously shown a device that uses radiofrequency energy to remove the patch to be highly effective in a ten patient pilot study, with 80% response rate that was durable over 1 year.
The purpose of this trial is to demonstrate the previous study was not due to placebo effect alone, with a sham controlled arm. Patients would then crossover to treatment at 6 months after sham. All males and non-pregnant females over 18 years old with previously diagnosed inlet patch causing symptoms of globus, with > 50% severity on a visual analogue score, are eligible.
Read the detailed description
Inlet patch is a congenital anomaly of the upper oesophagus, consisting of stomach lining that is in an aberrant position. Prevalence is up to 10% on endoscopy studies and 5% on post mortem studies. There is thought to be a link with another condition of the lower oesophagus called Barrett's oesophagus, although there is limited evidence. Unlike Barrett's oesophagus, progression to cancer from an inlet patch is exceptionally rare.
The inlet patch can produce acid and mucus, and is associated with symptoms including sore throat, cough and hoarseness. One particular symptom, called globus pharyngeus (the feeling of a ball in the back of the throat) is often associated with an inlet patch.
There is no recognised treatment for symptomatic inlet patch. Anti-acid medications works for some but not all, which may in part be explained by the lack of acid producing cells in some inlet patches. Ablation of the inlet patch has been successful in small series using Argon Plasma Coagulation. This device is, however, associated with inter user variability and unpredictable depth of ablation. Radiofrequency ablation (RFA) using the BarrxTM System is a National Institute for Health and Clinical Excellence (NICE) and FDA approved device for treatment of abnormal oesophageal lining, which has shown to be successful in reversing Barrett's oesophagus to normal squamous lining. These devices are advantageous as the depth of ablation is controlled. The investigators have previously demonstrated, in a pilot study, that these devices are safe and effective for reversal of inlet patch to normal mucosa, with improvement in symptoms.
This study will use the BarrxTM system to treat patients with symptomatic inlet patch that is refractory to standard anti-acid medication, in a blinded sham controlled trial.
- Conditions
- Barrett Esophagus
- Being tested
- Radiofrequency ablation (RFA)
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation (RFA)Procedure or surgery
Ablation using the Barrx RFA System is a new technique for field ablation in the oesophagus. It has been used for eradication of diseased epithelium of all three subclasses of Barrett's oesophagus (non-dysplastic Intestinal metaplasia (IM), Low grade dysplasia (LGD) and High grade dysplasia (HGD). The BarrxTM RFA System uses ultra short pulse RF energy delivering 40Watts/cm2 power density and 12Joule/cm2 energy density, and affects the mucosa whilst preserving the submucosa.
Clinical trials have suggested that it is safe and effective for treating non-dysplastic IM, LGD and HGD in Barrett's oesophagus . Long term data show the effect to be durable over 5 years.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation (RFA) | Experimental | Radiofrequency ablation (RFA) Receives: Procedure: Radiofrequency ablation (RFA) |
| Sham procedure | No intervention | Endoscopy will be performed under conscious sedation and all BarrX RFA equipment will be set up in room. A sound recording of the BarrxTM RFA device will be played (a distinct bell sound that is emitted from the generator) during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in globus symptoms
>50% reduction in globus as assessed by improvement in patient symptom scoring
Measured: 6 months post ablation
Endoscopic eradication of inlet patch
Eradication of inlet patch as assessed by endoscopic investigation
Measured: Change from 6 months to 12 months post final ablation
Histological reversal to squamous mucosa
Complete histological reversal to squamous mucosa as assessed by histological staining of the biopsy samples
Measured: Change at 6 and 12 months
Change in surface area of residual inlet patch post ablation
Change in surface area of residual inlet patch post ablation
Measured: Change at 6 and 12 months
Secondary outcomes (4)
Oesophageal pH pre and post ablation
Oesophageal pH pre and post ablation
Measured: Change at Pre-screening and 12 months
Adverse events
Adverse event incidence at any time during the study
Measured: Through study completion, an average of 12 months
Presence of buried mucosa consistent with inlet patch
Presence of buried mucosa consistent with inlet patch
Measured: During endoscopy
Symptomatic response for cough, hoarseness and sore throat using Visual Analogue Scale (VAS)
Symptomatic response for cough, hoarseness and sore throat using VAS
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start6 Mar 2018
- Primary completion30 Jan 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Dunn, Principal investigator, Consultant Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471052
- Sponsor's protocol ID
- 216038
- Status last verified
- Feb 2020
- First submitted
- 7 Mar 2018
- Last updated
- 12 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 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Radiofrequency Ablation Versus a Sham Procedure for Symptomatic Cervical Inlet Patch
- ClinicalTrials.gov ID
- NCT03471052
- Acronym / sponsor ID
- 216038
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 20 Mar 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.
Inlet patch is a congenital condition of the upper oesophagus, consisting of stomach lining that is in the wrong place. It affects 5% of the population. Symptoms are a feeling of a ball in the back of the throat (called chronic globus sensation), cough and sore throat - these account for 4% of general practitioner (GP) referral to Ear Nose \& Throat departments.
There is no recognised treatment. Drugs that reduce acid may help but do not block mucus production. Argon Plasma coagulation has been shown to be successful but limited to a few expert centres. The investigators have previously shown a device that uses radiofrequency energy to remove the patch to be highly effective in a ten patient pilot study, with 80% response rate that was durable over 1 year.
The purpose of this trial is to demonstrate the previous study was not due to placebo effect alone, with a sham controlled arm. Patients would then crossover to treatment at 6 months after sham. All males and non-pregnant females over 18 years old with previously diagnosed inlet patch causing symptoms of globus, with > 50% severity on a visual analogue score, are eligible.
Detailed description
Inlet patch is a congenital anomaly of the upper oesophagus, consisting of stomach lining that is in an aberrant position. Prevalence is up to 10% on endoscopy studies and 5% on post mortem studies. There is thought to be a link with another condition of the lower oesophagus called Barrett's oesophagus, although there is limited evidence. Unlike Barrett's oesophagus, progression to cancer from an inlet patch is exceptionally rare.
The inlet patch can produce acid and mucus, and is associated with symptoms including sore throat, cough and hoarseness. One particular symptom, called globus pharyngeus (the feeling of a ball in the back of the throat) is often associated with an inlet patch.
There is no recognised treatment for symptomatic inlet patch. Anti-acid medications works for some but not all, which may in part be explained by the lack of acid producing cells in some inlet patches. Ablation of the inlet patch has been successful in small series using Argon Plasma Coagulation. This device is, however, associated with inter user variability and unpredictable depth of ablation. Radiofrequency ablation (RFA) using the BarrxTM System is a National Institute for Health and Clinical Excellence (NICE) and FDA approved device for treatment of abnormal oesophageal lining, which has shown to be successful in reversing Barrett's oesophagus to normal squamous lining. These devices are advantageous as the depth of ablation is controlled. The investigators have previously demonstrated, in a pilot study, that these devices are safe and effective for reversal of inlet patch to normal mucosa, with improvement in symptoms.
This study will use the BarrxTM system to treat patients with symptomatic inlet patch that is refractory to standard anti-acid medication, in a blinded sham controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation (RFA) | Experimental | Procedure: Radiofrequency ablation (RFA)Radiofrequency ablation (RFA) |
| Sham procedure | No intervention | –Endoscopy will be performed under conscious sedation and all BarrX RFA equipment will be set up in room. A sound recording of the BarrxTM RFA device will be played (a distinct bell sound that is emitted from the generator) during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with symptoms secondary to Inlet patch and globus score > 50 on Visual Analogue Scale (VAS)
- Histological confirmation of presence of Inlet patch
- Symptoms not responsive or partially responsive to (proton pump inhibitor) PPI therapy for > = 6 weeks
- Males and non-pregnant females over the age of 18 years. Female patients who are pre-menopausal must practice a medically acceptable form of contraception.
- Patients must sign an informed consent form.
Key exclusion criteria (11 listed)
- Patients in whom endoscopy is contraindicated.
- No globus symptoms
- Patients previously or currently treated for oesophageal dysplasia or cancer
- Patients with eosinophilic oesophagitis
- Patients with oesophageal varices
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 ablation (RFA)Ablation using the Barrx RFA System is a new technique for field ablation in the oesophagus. It has been used for eradication of diseased epithelium of all three subclasses of Barrett's oesophagus (non-dysplastic Intestinal metaplasia (IM), Low grade dysplasia (LGD) and High grade dysplasia (HGD). The BarrxTM RFA System uses ultra short pulse RF energy delivering 40Watts/cm2 power density and 12Joule/cm2 energy density, and affects the mucosa whilst preserving the submucosa. Clinical trials have suggested that it is safe and effective for treating non-dysplastic IM, LGD and HGD in Barrett's oesophagus . Long term data show the effect to be durable over 5 years. | Procedure or surgery | Radiofrequency ablation (RFA) |
Primary outcome
Reduction in globus symptoms
Time frame: 6 months post ablation
>50% reduction in globus as assessed by improvement in patient symptom scoring
Endoscopic eradication of inlet patch
Time frame: Change from 6 months to 12 months post final ablation
Eradication of inlet patch as assessed by endoscopic investigation
Histological reversal to squamous mucosa
Time frame: Change at 6 and 12 months
Complete histological reversal to squamous mucosa as assessed by histological staining of the biopsy samples
Change in surface area of residual inlet patch post ablation
Time frame: Change at 6 and 12 months
Change in surface area of residual inlet patch post ablation
4 secondary outcomes
Oesophageal pH pre and post ablation
Time frame: Change at Pre-screening and 12 months
Adverse events
Time frame: Through study completion, an average of 12 months
Presence of buried mucosa consistent with inlet patch
Time frame: During endoscopy
Symptomatic response for cough, hoarseness and sore throat using Visual Analogue Scale (VAS)
Time frame: Through study completion, an average of 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
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Barrett Esophagus
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.
Jason Dunn principal investigator
Consultant Gastroenterology
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 (RFA) in people with Barrett Esophagus, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 11 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 12 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 United Kingdom. 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. 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 Jason Dunn (02071887188, GMSresearch@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in globus symptoms (time frame: 6 months post ablation). The study lists 4 primary outcomes in all. 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 12 Feb 2020.