GERDNCT05131932
Ablation of Esophageal Inlet Patches in Patients Referred for Bravo pH-Testing
A study testing Endoscopic ablation of inlet patch in people with GERD and Cough, run by Assaf-Harofeh Medical Center.
Trial summary
Patients with suspected extra-esophageal manifestations of gastro-esophageal reflux disease (GERD), such as cough, hoarseness, and globus, are often referred for pH testing. However, many of these symptoms may actually be due to an esophageal inlet patch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD, Cough, Metaplasia
- What is being tested?
- Endoscopic ablation of inlet patch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2024
- 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
- Adult patients (age 18 and above)
- Referred for pH-testing for evaluation of possible extraesophageal-GERD
- Prior upper endoscopy performed
- Prior trial of PPI with an inadequate response
Who cannot join
- Patients who do not give consent
- Patients with abnormalities on their prior endoscopy including a significant hiatal hernia (>3 cm) or significant erosive esophagitis (Los Angeles class B or greater)
- Patients who did not fail a prior trial of PPI therapy
About this study
Official title: Ablation of Esophageal Inlet Patches in Patients Referred for pH-Testing Due to Possible Extra-Esophageal Symptoms of Gastro-Esophageal Reflux Disease
Patients with suspected extra-esophageal manifestations of gastro-esophageal reflux disease (GERD), such as cough, hoarseness, and globus, are often referred for pH testing. However, many of these symptoms may actually be due to an esophageal inlet patch. We aim to evaluate patients referred for pH testing to see if they have an inlet patch, to perform ablation of the inlet patch if detected, and then compare the outcomes of patients with an inlet patch who underwent ablation versus those without an inlet patch.
Read the detailed description
Background The diagnosis of gastro-esophageal reflux disease (GERD) is difficult when patients present with extra-esophageal symptoms such as chronic cough, frequent throat clearing, globus sensation, sore throat, and hoarseness, as opposed to the traditional symptoms of heartburn and regurgitation.[1-4] These patients are often given a trial of proton pump inhibitors (PPIs) to see if their symptoms improve. They often undergo an upper endoscopy, which is usually unrevealing,[5] and they may be evaluated by other specialties such as otolaryngology and pulmonology. Eventually, some of these patients are referred for esophageal pH-testing to evaluate for objective evidence of acid reflux.
The symptoms of extra-esophageal GERD (EE-GERD) are not specific for GERD and many of them overlap with the symptoms from inlet patches, also known as heterotopic gastric mucosa.[6-7] Inlet patches consist of small areas of gastric mucosa in the upper esophagus that are capable of producing acid.[8-10] Studies in which inlet patches are endoscopically ablated have shown improvement in several extra-esophageal symptoms including globus sensation, sore throat, and cough.[11-15] As inlet patches are notoriously overlooked on upper endoscopy[16] and can cause many of the same symptoms as EE-GERD, we suspect that they may be responsible for the symptoms in some patients who are referred for pH-testing due to suspected EE-GERD. We believe that a careful inspection of the upper esophagus will reveal inlet patches that were missed on initial endoscopy and that ablation of these inlet patches will help improve the patients' symptoms more than the standard treatment for EE-GERD.
Aims The primary aim of this study is to evaluate the improvement in symptoms of patients referred for pH-testing for suspected EE-GERD that are treated with endoscopic ablation of an inlet patch versus those who receive standard PPI therapy. Secondarily, we seek to determine the prevalence of inlet patches in these patients with reportedly normal endoscopies, as well as percentage of patients in this group with a positive pH study.
Methods Patients referred for pH-testing due to symptoms of possible EE-GERD will be evaluated. These patients will have their prior medical history reviewed. Those with a prior normal endoscopy and inadequate response to PPI therapy will be included.
Patients' symptoms will be assessed via a questionnaire across 8 domains including 6 symptoms of possible EE-GERD and 2 subjective scores of how the symptoms are affecting their lives (see Questionnaire below). A visual Likert scale from 0 to 10 will be used. An overall symptom score will be calculated based on the results of the 8 individual domains.
Patients will then undergo an upper endoscopy. During the endoscopy, care will be taken to assess for possible inlet patches. Advanced imaging techniques such as i-scan imaging will be used to aid in the detection of inlet patches. If one or more inlet patches are found, the number, size, and shape will be recorded, and it will be biopsied for histological confirmation. The inlet patch will then be ablated via the use of argon plasma coagulation (APC) as has been performed in prior studies.[11-13] During the endoscopy, a Bravo pH capsule will also be placed per standard protocol to complete a 48-hour pH study. The Bravo data will be interpreted according to standard procedure with a positive study defined as an elevated DeMeester score on either study day. All studies will be performed off of anti-acid medications such as PPIs.
The patients' symptoms will be re-assessed at 2 and 6 months following the endoscopy. This will be performed via telephone interviews with the patients completing the same symptom assessments as prior to the endoscopy. Changes in their medications and treatment as a result of the Bravo pH study results will also be evaluated.
The primary end point will be the symptom improvement in overall score in patients who underwent ablation of inlet patches versus those without inlet patches.
Inclusion Criteria
- Adult patients (age 18 and above)
- Referred for pH-testing for evaluation of possible EE-GERD
- Prior upper endoscopy performed
- Prior trial of PPI with an inadequate response Exclusion Criteria
- Patients who do not give consent
- Patients with abnormalities on their prior endoscopy including a significant hiatal hernia (>3 cm) or significant erosive esophagitis (Los Angeles class B or greater)
- Patients who did not fail a prior trial of PPI therapy Anticipated number of subjects: 100
- Conditions
- GERD, Cough, Metaplasia
- Being tested
- Endoscopic ablation of inlet patch
- Medical subject headings
- Gastroesophageal Reflux, Cough, Metaplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ablation of inlet patchProcedure or surgery
Endoscopic ablation of inlet patch using argon plasma coagulation (APC)
| Study group | Role | What they receive |
|---|---|---|
| Inlet patch | Experimental | Patients found to have an inlet patch on upper endoscopy Receives: Procedure: Endoscopic ablation of inlet patch |
| Controls | No intervention | Patients without an inlet patch on upper endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms 6 months after procedure
The overall symptoms score
Measured: 6 months after procedure
Secondary outcomes (1)
Symptoms 2 months after procedure
The overall symptoms score
Measured: 2 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for GERDStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131932
- Sponsor's protocol ID
- 0205-21-ASF
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be kept securely at the medical center
Publications
Vaezi MF, Katzka D, Zerbib F. Extraesophageal Symptoms and Diseases Attributed to GERD: Where is the Pendulum Swinging Now? Clin Gastroenterol Hepatol. 2018 Jul;16(7):1018-1029. doi: 10.1016/j.cgh.2018.02.001. Epub 2018 Feb 7.
PubMed 29427733Madanick RD. Extraesophageal presentations of GERD: where is the science? Gastroenterol Clin North Am. 2014 Mar;43(1):105-20. doi: 10.1016/j.gtc.2013.11.007. Epub 2013 Dec 28.
PubMed 24503362Ghisa M, Della Coletta M, Barbuscio I, Marabotto E, Barberio B, Frazzoni M, De Bortoli N, Zentilin P, Tolone S, Ottonello A, Lorenzon G, Savarino V, Savarino E. Updates in the field of non-esophageal gastroesophageal reflux disorder. Expert Rev Gastroenterol Hepatol. 2019 Sep;13(9):827-838. doi: 10.1080/17474124.2019.1645593. Epub 2019 Jul 22.
PubMed 31322443Sidhwa F, Moore A, Alligood E, Fisichella PM. Diagnosis and Treatment of the Extraesophageal Manifestations of Gastroesophageal Reflux Disease. Ann Surg. 2017 Jan;265(1):63-67. doi: 10.1097/SLA.0000000000001907.
PubMed 27455157Zullo A, Fiorini G, Bassotti G, Bachetti F, Monica F, Macor D, Paoluzi OA, Scaccianoce G, Portincasa P, De Francesco V, Lorenzetti R, Saracino IM, Pavoni M, Vaira D. Upper Endoscopy in Patients with Extra-Oesophageal Reflux Symptoms: A Multicentre Study. GE Port J Gastroenterol. 2020 Aug;27(5):312-317. doi: 10.1159/000505581. Epub 2020 Feb 4.
PubMed 32999903von Rahden BH, Stein HJ, Becker K, Liebermann-Meffert D, Siewert JR. Heterotopic gastric mucosa of the esophagus: literature-review and proposal of a clinicopathologic classification. Am J Gastroenterol. 2004 Mar;99(3):543-51. doi: 10.1111/j.1572-0241.2004.04082.x.
PubMed 15056100Ciocalteu A, Popa P, Ionescu M, Gheonea DI. Issues and controversies in esophageal inlet patch. World J Gastroenterol. 2019 Aug 14;25(30):4061-4073. doi: 10.3748/wjg.v25.i30.4061.
PubMed 31435164Galan AR, Katzka DA, Castell DO. Acid secretion from an esophageal inlet patch demonstrated by ambulatory pH monitoring. Gastroenterology. 1998 Dec;115(6):1574-6. doi: 10.1016/s0016-5085(98)70038-1.
PubMed 9834287Hamilton JW, Thune RG, Morrissey JF. Symptomatic ectopic gastric epithelium of the cervical esophagus. Demonstration of acid production with Congo red. Dig Dis Sci. 1986 Apr;31(4):337-42. doi: 10.1007/BF01311666.
PubMed 3956328Nakajima H, Munakata A, Sasaki Y, Yoshida Y. pH profile of esophagus in patients with inlet patch of heterotopic gastric mucosa after tetragastrin stimulation. An endoscopic approach. Dig Dis Sci. 1993 Oct;38(10):1915-9. doi: 10.1007/BF01296118.
PubMed 8404414Meining A, Bajbouj M, Preeg M, Reichenberger J, Kassem AM, Huber W, Brockmeyer SJ, Hannig C, Hofler H, Prinz C, Schmid RM. Argon plasma ablation of gastric inlet patches in the cervical esophagus may alleviate globus sensation: a pilot trial. Endoscopy. 2006 Jun;38(6):566-70. doi: 10.1055/s-2006-925362.
PubMed 16802267Bajbouj M, Becker V, Eckel F, Miehlke S, Pech O, Prinz C, Schmid RM, Meining A. Argon plasma coagulation of cervical heterotopic gastric mucosa as an alternative treatment for globus sensations. Gastroenterology. 2009 Aug;137(2):440-4. doi: 10.1053/j.gastro.2009.04.053. Epub 2009 May 4.
PubMed 19410576Klare P, Meining A, von Delius S, Wolf P, Konukiewitz B, Schmid RM, Bajbouj M. Argon plasma coagulation of gastric inlet patches for the treatment of globus sensation: it is an effective therapy in the long term. Digestion. 2013;88(3):165-71. doi: 10.1159/000355274. Epub 2013 Oct 18.
PubMed 24157960Dunn JM, Sui G, Anggiansah A, Wong T. Radiofrequency ablation of symptomatic cervical inlet patch using a through-the-scope device: a pilot study. Gastrointest Endosc. 2016 Dec;84(6):1022-1026.e2. doi: 10.1016/j.gie.2016.06.037. Epub 2016 Jul 1.
PubMed 27373671Kristo I, Rieder E, Paireder M, Schwameis K, Jomrich G, Dolak W, Parzefall T, Riegler M, Asari R, Schoppmann SF. Radiofrequency ablation in patients with large cervical heterotopic gastric mucosa and globus sensation: Closing the treatment gap. Dig Endosc. 2018 Mar;30(2):212-218. doi: 10.1111/den.12959. Epub 2017 Oct 3.
PubMed 28884487
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation of Esophageal Inlet Patches in Patients Referred for pH-Testing Due to Possible Extra-Esophageal Symptoms of Gastro-Esophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT05131932
- Acronym / sponsor ID
- 0205-21-ASF
- Conditions
- GERD, Cough, Metaplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Nov 2021 (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.
Patients with suspected extra-esophageal manifestations of gastro-esophageal reflux disease (GERD), such as cough, hoarseness, and globus, are often referred for pH testing. However, many of these symptoms may actually be due to an esophageal inlet patch. We aim to evaluate patients referred for pH testing to see if they have an inlet patch, to perform ablation of the inlet patch if detected, and then compare the outcomes of patients with an inlet patch who underwent ablation versus those without an inlet patch.
Detailed description
Background The diagnosis of gastro-esophageal reflux disease (GERD) is difficult when patients present with extra-esophageal symptoms such as chronic cough, frequent throat clearing, globus sensation, sore throat, and hoarseness, as opposed to the traditional symptoms of heartburn and regurgitation.[1-4] These patients are often given a trial of proton pump inhibitors (PPIs) to see if their symptoms improve. They often undergo an upper endoscopy, which is usually unrevealing,[5] and they may be evaluated by other specialties such as otolaryngology and pulmonology. Eventually, some of these patients are referred for esophageal pH-testing to evaluate for objective evidence of acid reflux.
The symptoms of extra-esophageal GERD (EE-GERD) are not specific for GERD and many of them overlap with the symptoms from inlet patches, also known as heterotopic gastric mucosa.[6-7] Inlet patches consist of small areas of gastric mucosa in the upper esophagus that are capable of producing acid.[8-10] Studies in which inlet patches are endoscopically ablated have shown improvement in several extra-esophageal symptoms including globus sensation, sore throat, and cough.[11-15] As inlet patches are notoriously overlooked on upper endoscopy[16] and can cause many of the same symptoms as EE-GERD, we suspect that they may be responsible for the symptoms in some patients who are referred for pH-testing due to suspected EE-GERD. We believe that a careful inspection of the upper esophagus will reveal inlet patches that were missed on initial endoscopy and that ablation of these inlet patches will help improve the patients' symptoms more than the standard treatment for EE-GERD.
Aims The primary aim of this study is to evaluate the improvement in symptoms of patients referred for pH-testing for suspected EE-GERD that are treated with endoscopic ablation of an inlet patch versus those who receive standard PPI therapy. Secondarily, we seek to determine the prevalence of inlet patches in these patients with reportedly normal endoscopies, as well as percentage of patients in this group with a positive pH study.
Methods Patients referred for pH-testing due to symptoms of possible EE-GERD will be evaluated. These patients will have their prior medical history reviewed. Those with a prior normal endoscopy and inadequate response to PPI therapy will be included.
Patients' symptoms will be assessed via a questionnaire across 8 domains including 6 symptoms of possible EE-GERD and 2 subjective scores of how the symptoms are affecting their lives (see Questionnaire below). A visual Likert scale from 0 to 10 will be used. An overall symptom score will be calculated based on the results of the 8 individual domains.
Patients will then undergo an upper endoscopy. During the endoscopy, care will be taken to assess for possible inlet patches. Advanced imaging techniques such as i-scan imaging will be used to aid in the detection of inlet patches. If one or more inlet patches are found, the number, size, and shape will be recorded, and it will be biopsied for histological confirmation. The inlet patch will then be ablated via the use of argon plasma coagulation (APC) as has been performed in prior studies.[11-13] During the endoscopy, a Bravo pH capsule will also be placed per standard protocol to complete a 48-hour pH study. The Bravo data will be interpreted according to standard procedure with a positive study defined as an elevated DeMeester score on either study day. All studies will be performed off of anti-acid medications such as PPIs.
The patients' symptoms will be re-assessed at 2 and 6 months following the endoscopy. This will be performed via telephone interviews with the patients completing the same symptom assessments as prior to the endoscopy. Changes in their medications and treatment as a result of the Bravo pH study results will also be evaluated.
The primary end point will be the symptom improvement in overall score in patients who underwent ablation of inlet patches versus those without inlet patches.
Inclusion Criteria
- Adult patients (age 18 and above)
- Referred for pH-testing for evaluation of possible EE-GERD
- Prior upper endoscopy performed
- Prior trial of PPI with an inadequate response Exclusion Criteria
- Patients who do not give consent
- Patients with abnormalities on their prior endoscopy including a significant hiatal hernia (>3 cm) or significant erosive esophagitis (Los Angeles class B or greater)
- Patients who did not fail a prior trial of PPI therapy Anticipated number of subjects: 100
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inlet patch | Experimental | Procedure: Endoscopic ablation of inlet patchPatients found to have an inlet patch on upper endoscopy |
| Controls | No intervention | –Patients without an inlet patch on upper endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age 18 and above)
- Referred for pH-testing for evaluation of possible extraesophageal-GERD
- Prior upper endoscopy performed
- Prior trial of PPI with an inadequate response
Key exclusion criteria (3 listed)
- Patients who do not give consent
- Patients with abnormalities on their prior endoscopy including a significant hiatal hernia (>3 cm) or significant erosive esophagitis (Los Angeles class B or greater)
- Patients who did not fail a prior trial of PPI therapy
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 |
|---|---|---|
| Endoscopic ablation of inlet patchEndoscopic ablation of inlet patch using argon plasma coagulation (APC) | Procedure or surgery | Inlet patch |
Primary outcome
Symptoms 6 months after procedure
Time frame: 6 months after procedure
The overall symptoms score
1 secondary outcome
Symptoms 2 months after procedure
Time frame: 2 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Background: PubMed 29427733Vaezi MF, Katzka D, Zerbib F. Extraesophageal Symptoms and Diseases Attributed to GERD: Where is the Pendulum Swinging Now? Clin Gastroenterol Hepatol. 2018 Jul;16(7):1018-1029. doi: 10.1016/j.cgh.2018.02.001. Epub 2018 Feb 7.
- Background: PubMed 24503362Madanick RD. Extraesophageal presentations of GERD: where is the science? Gastroenterol Clin North Am. 2014 Mar;43(1):105-20. doi: 10.1016/j.gtc.2013.11.007. Epub 2013 Dec 28.
- Background: PubMed 31322443Ghisa M, Della Coletta M, Barbuscio I, Marabotto E, Barberio B, Frazzoni M, De Bortoli N, Zentilin P, Tolone S, Ottonello A, Lorenzon G, Savarino V, Savarino E. Updates in the field of non-esophageal gastroesophageal reflux disorder. Expert Rev Gastroenterol Hepatol. 2019 Sep;13(9):827-838. doi: 10.1080/17474124.2019.1645593. Epub 2019 Jul 22.
- Background: PubMed 27455157Sidhwa F, Moore A, Alligood E, Fisichella PM. Diagnosis and Treatment of the Extraesophageal Manifestations of Gastroesophageal Reflux Disease. Ann Surg. 2017 Jan;265(1):63-67. doi: 10.1097/SLA.0000000000001907.
- Background: PubMed 32999903Zullo A, Fiorini G, Bassotti G, Bachetti F, Monica F, Macor D, Paoluzi OA, Scaccianoce G, Portincasa P, De Francesco V, Lorenzetti R, Saracino IM, Pavoni M, Vaira D. Upper Endoscopy in Patients with Extra-Oesophageal Reflux Symptoms: A Multicentre Study. GE Port J Gastroenterol. 2020 Aug;27(5):312-317. doi: 10.1159/000505581. Epub 2020 Feb 4.
- Background: PubMed 15056100von Rahden BH, Stein HJ, Becker K, Liebermann-Meffert D, Siewert JR. Heterotopic gastric mucosa of the esophagus: literature-review and proposal of a clinicopathologic classification. Am J Gastroenterol. 2004 Mar;99(3):543-51. doi: 10.1111/j.1572-0241.2004.04082.x.
- Background: PubMed 31435164Ciocalteu A, Popa P, Ionescu M, Gheonea DI. Issues and controversies in esophageal inlet patch. World J Gastroenterol. 2019 Aug 14;25(30):4061-4073. doi: 10.3748/wjg.v25.i30.4061.
- Background: PubMed 9834287Galan AR, Katzka DA, Castell DO. Acid secretion from an esophageal inlet patch demonstrated by ambulatory pH monitoring. Gastroenterology. 1998 Dec;115(6):1574-6. doi: 10.1016/s0016-5085(98)70038-1.
- Background: PubMed 3956328Hamilton JW, Thune RG, Morrissey JF. Symptomatic ectopic gastric epithelium of the cervical esophagus. Demonstration of acid production with Congo red. Dig Dis Sci. 1986 Apr;31(4):337-42. doi: 10.1007/BF01311666.
- Background: PubMed 8404414Nakajima H, Munakata A, Sasaki Y, Yoshida Y. pH profile of esophagus in patients with inlet patch of heterotopic gastric mucosa after tetragastrin stimulation. An endoscopic approach. Dig Dis Sci. 1993 Oct;38(10):1915-9. doi: 10.1007/BF01296118.
- Background: PubMed 16802267Meining A, Bajbouj M, Preeg M, Reichenberger J, Kassem AM, Huber W, Brockmeyer SJ, Hannig C, Hofler H, Prinz C, Schmid RM. Argon plasma ablation of gastric inlet patches in the cervical esophagus may alleviate globus sensation: a pilot trial. Endoscopy. 2006 Jun;38(6):566-70. doi: 10.1055/s-2006-925362.
- Background: PubMed 19410576Bajbouj M, Becker V, Eckel F, Miehlke S, Pech O, Prinz C, Schmid RM, Meining A. Argon plasma coagulation of cervical heterotopic gastric mucosa as an alternative treatment for globus sensations. Gastroenterology. 2009 Aug;137(2):440-4. doi: 10.1053/j.gastro.2009.04.053. Epub 2009 May 4.
- Individual participant dataSharing planned: No. IPD will be kept securely at the medical center
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ablation of inlet patch in people with GERD and Cough, run by Assaf-Harofeh Medical Center.
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 4 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms 6 months after procedure (time frame: 6 months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05131932, which also lists 16 linked publications.
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 23 Nov 2021.