GERDNCT05696184
Mechanisms Preventing Pharyngeal Reflux
A study testing Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy and Slow and rapid intra-esophageal infusion in people with GERD, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The overall goal is to define and characterize the manometric characteristics of UES incompetence associated with objectively documented pharyngeal reflux. The investigators will use endoscopic reflux detection as gold standard. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD
- What is being tested?
- Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy and Slow and rapid intra-esophageal infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2013to 12 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 85
- GERD patients with complaints of regurgitation and supra-esophageal symptoms will be included and recruited from our GI \& Otolaryngology clinics
- GERD patients without complaint of supra-esophageal symptoms and regurgitation will be included and recruited from our GI \& Otolaryngology clinics
- Asthma patients with and without supra-esophageal symptoms will be included and recruited from clinics affiliated with Medical College of Wisconsin. Asthma patients with the following classifications of asthma severity will be included: intermittent, mild persistent, moderate persistent, and severe persistent (as long as no acute asthma exacerbation at the time of the study)
- Patient definition will be based on position statement and technical reviews of the American Gastroenterological Association and Montreal definition and classification of gastroesophageal and reflux disease (Am J Gastroenterol. 2006;101:1900-1920).
- SERD is defined as patients on long term acid suppressive therapy complaining of persistent regurgitation along with supra-esophageal manifestations such as burning throat, asthma, chronic cough, or hoarseness. Patients will be screened by Reflux Symptom Index > 13.
- Barrett's esophagus patients will be recruited based on histological diagnosis from previous endoscopic biopsy that will be found using the clinical database warehouse.
Who cannot join
- Age <18 or >85
- Active alcohol or drug abuse
- History of ear, nose, throat and pulmonary diseases suspected of being GERD induced
- History of head and neck malignancy and chemo-radiation therapy to the head and neck
- Unable to give consent
- Pregnant women (see justification in the Women and Minority Inclusion in Clinical Research section)
Show all 9Show fewer
- History of allergy to Lidocaine for nasal topical anesthesia
- Allergy to green food dye
- Asthma patients with an acute asthma exacerbation with symptoms including breathlessness, wheezing, and chest tightness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53086
Reza Shaker, MD, 4149556840, rshaker@mcw.edu
Mark Kern, 4148053826, mkern@mcw.edu
About this study
Official title: Pathophysiology of Pharyngo-esophageal Junction and Esophageal Mechanisms Preventing Pharyngeal Reflux of Gastric Content
The overall goal is to define and characterize the manometric characteristics of UES incompetence associated with objectively documented pharyngeal reflux. The investigators will use endoscopic reflux detection as gold standard.
Read the detailed description
- Characterization of UES pressure response to liquid refluxate . Hypothesis 1: UES pressure responses to liquid refluxate are significantly different in patients suffering from both pharyngeal reflux (regurgitation) and SE-GERD compared to healthy controls and GERD patients without regurgitation and SE-GERD. Hypothesis 2: these differences are significantly more pronounced during sustained esophageal distensions induced by slow intra-esophageal infusions compared to those due to rapid infusions.
- Determination and characterization of the contribution of sub-sphincteric striated esophagus to the UES pressure barrier. Hypothesis 3: In healthy individual, in addition to the UES, proximal striated esophagus distal to the area normally incorporated in UES high pressure zone contracts in response to liquid reflux irrespective of secondary peristalsis. This contraction potentially prevents contact of refluxate with UES and provides an added layer of protection against pharyngeal reflux. Hypothesis 4: in patients with SE-GERD and perception of regurgitation associated with true pharyngeal reflux, both UES and sub-sphincteric responses are abnormal. Hypothesis 5: in patients with perception of regurgitation but without entry of refluxate into the pharynx, only the sub-sphincteric contraction will be abnormal.
- Characterization of reflux- induced esophageal motor activity. Hypothesis 6: While in healthy individuals the predominant esophageal response to reflux is secondary peristalsis, in patients with regurgitation and SE-GERD this response is significantly altered and includes simultaneous, segmental contraction, partially propagated or low amplitude secondary peristalsis and absence of motor response.
- Mechanisms of esophago- pharyngeal reflux. Hypothesis 7: pharyngeal reflux occurs when the reflux-induced intra-esophageal pressure exceeds the concurrent UES pressure. This can occur during the following conditions, a. partial UES relaxation, b. complete UES relaxation, c. absence of esophago-UES contractile reflex, d. Belch, e. incomplete swallow and f. excessive intra-esophageal pressure. The investigators will investigate these mechanisms under simulated reflux conditions testing different reflux variables.
- Characterization of UES pressure response to liquid refluxate in asthma patients. Hypothesis 8: UES pressure responses to liquid refluxate are significantly different in patients suffering from asthma compared to healthy controls. Hypothesis 9: these differences are significantly more pronounced during sustained esophageal distensions induced by slow intra-esophageal infusions compared to those due to rapid infusions.
- Characterization of UES pressure response to liquid refluxate at various levels of the esophagus in healthy controls. Hypothesis 10: The UES pressure response is significantly different for various locations of liquid refluxate in the esophagus. Hypothesis 11: the closer the liquid refluxate to the UES, the stronger the response will be.
- Characterization of UES pressure response to liquid refluxate at various levels of the esophagus in GERD patients. Hypothesis 12: The UES pressure response to liquid refluxate at various levels of the esophagus will be significantly different in GERD patients compared to healthy participants. Hypothesis 13: Overall, the UES pressure response to liquid refluxate in GERD patients will be less pronounced than in healthy controls. Hypothesis 14: As the liquid refluxate gets closer to the UES, the UES pressure response to liquid refluxate will increase.
- Characterization of UES and esophageal body response to rapid intra-esophageal air injection after esophageal acid sensitization. Supra-esophageal reflux disease is associated with changing in esophageal reflexes, such as esophago-contractile reflex (EUCR) and esophago-relaxation reflex (EURR). Intra-esophageal rapid injection can trigger EURR. 15: The investigators hypothesize that acid sensitization will affect UES and esophageal body response to rapid air injection. Hypothesis 16:The effect of of UES and esophageal body response to rapid air injection after esophageal acid sensitization will be different in healthy compared to GERD patients.
- Characterization of deglutition before and after intra-esophageal acid or saline infusion. Supra-esophageal reflux disease is associated with changes in deglutitive pressures in UES, esophageal body and LES. The investigators hypothesize that esophageal acidification will affect UES, esophageal body and LES pressures during swallowing. The effect may be different in healthy compared to GERD patients. The investigators also expect to see a difference in parameter's between diseased Barrett's esophagus patients and the healthy population.
- Characterization of deglutition at different phases of the breathing cycle. Typical pattern in healthy adults is swallowing near the end of expiration followed by expiration after swallow. The investigators hypothesize that swallowing at different phases of breathing will affect the UES, esophageal body, and LES pressures during swallowing.
- Characterization of UES pressure response to liquid refluxate at various level of the esophagus in SERD patients. Hypothesis 17: As the liquid refluxate gets closer to the UES, SERD patients will have a lower compensatory response compared to GERD and healthy controls and lower contraction of the proximal striated esophagus (measured by the Pharyngeal Contractile Integral)
- Conditions
- GERD
- Being tested
- Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy, Slow and rapid intra-esophageal infusion
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent manometry/impedance/pH with video pharyngo-laryngoscopyDiagnostic test
Combined manometric/impedance/pH recording: we will use combined solid-state high-resolution manometry and impedance catheter with 36 circumferential pressure sensors, spaced 1 cm apart, 18 impedance sensor couplets spaced 2 cm apart, 3 pH sensors spaced 7 and 10 cm respectively. The catheter will be introduced trans-nasally.
Concurrent video-pharyngo-laryngoscopy: to monitor concurrently the pharynx and larynx for entry of simulated refluxate we will use a laryngo-pharyngo-scope passed through the other nostril and positioned within the pharynx such that the UES inlet, vocal cords and pyriform sinuses are visualized. The laryngo-pharyngo-scope images will be synchronized with manometric/impedance/pH recordings by importing and superimposing the endoscopic images onto high resolution manometric recordings. A specially designed timer will be superimposed on the video images for durational analyses of endoscopic images.
Slow and rapid intra-esophageal infusionDiagnostic test
A 3 mm outer diameter injection tube will be placed through the nose in a fashion that the injection port will be located 5-7cm above the manometrically determined upper border of lower esophageal sphincter (LES). With this arrangement gastroesophageal reflux events will be simulated by intra-esophageal injection of body temperature1/2 normal saline (its ionic nature helps impedance recording and identification of intra-esophageal distribution), 0.1 N HCl. Infused liquid will be colored green using food dye for ease of recognition of pharyngeal reflux. Esophageal clearance will be verified by the presence of an effective peristalsis and return of intra-esophageal impedance and pressure to baseline. Endoscopic views of pharynx will be watched carefully during infusions. At the first sign of reflux, perfusion will be stopped, and participants will be instructed to swallow to avoid any potential airway compromise.
| Study group | Role | What they receive |
|---|---|---|
| GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD) | Active comparator | GERD patients with complaint of regurgitation and one of the following supra-esophageal symptoms attributed to reflux of gastric content: chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis and dental erosion i.e. SE-GERD. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing. Receives: Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy; Diagnostic Test: Slow and rapid intra-esophageal infusion |
| Age and gender matched healthy controls | Active comparator | Controls will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing. Receives: Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy; Diagnostic Test: Slow and rapid intra-esophageal infusion |
| Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint) | Active comparator | Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing. Receives: Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy; Diagnostic Test: Slow and rapid intra-esophageal infusion |
| Asthma patients with and without supra-esophageal symptoms | Active comparator | Asthma patients with and without supra-esophageal symptoms (these symptoms include chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis, and dental erosion). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing. Receives: Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy; Diagnostic Test: Slow and rapid intra-esophageal infusion |
| Age and gender matched patient controls for diagnosed Barrett's esophagus patients | Active comparator | Patient controls for diagnosed Barrett's esophagus patients. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing. Receives: Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy; Diagnostic Test: Slow and rapid intra-esophageal infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Data Analysis
All pressure measurements will be recorded at a 35HZ frequency and measured in reference to the atmospheric pressure UES and LES pressures will be measured utilizing the e-sleeve function of the manometric analysis software. All UES, LES and esophageal baseline pressures will be measured as peaks and troughs over 3 tidal volume respiratory cycles at stable resting conditions when no pharyngeal, gastric, esophageal, UES or LES events are present. Type, frequency, amplitude, onset, and duration of the UES response along with the LES and esophageal body response will be recorded.
Measured: During simulated reflux perfusion of the esophagus
Videoendoscopic data analysis
Onset of the entry of colored refluxate into the pharynx though the UES inlet will be determined and correlated with the UES, esophageal and LES pressure phenomena, impedance and pH events. Endoscopic documentation of pharyngeal reflux will be considered the gold standard and impedance and pH data will be compared to it.
Measured: During simulated reflux perfusion of the esophagus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Nov 2013
- Primary completion12 Oct 2026 (estimated)
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In a heterogeneous group of gastroesophageal reflux disease (GERD) patients, determine and characterize pressure phenomena of the upper esophageal sphincter (UES) incompetence confirmed by concurrent endoscopy.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Shaker, MD, Medical College of Wisconsin
- Investigators
- Reza Shaker, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696184
- Sponsor's protocol ID
- PRO00020544
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Pharyngo-esophageal Junction and Esophageal Mechanisms Preventing Pharyngeal Reflux of Gastric Content
- ClinicalTrials.gov ID
- NCT05696184
- Acronym / sponsor ID
- PRO00020544
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 25 Jan 2023 (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 overall goal is to define and characterize the manometric characteristics of UES incompetence associated with objectively documented pharyngeal reflux. The investigators will use endoscopic reflux detection as gold standard.
Detailed description
- Characterization of UES pressure response to liquid refluxate . Hypothesis 1: UES pressure responses to liquid refluxate are significantly different in patients suffering from both pharyngeal reflux (regurgitation) and SE-GERD compared to healthy controls and GERD patients without regurgitation and SE-GERD. Hypothesis 2: these differences are significantly more pronounced during sustained esophageal distensions induced by slow intra-esophageal infusions compared to those due to rapid infusions.
- Determination and characterization of the contribution of sub-sphincteric striated esophagus to the UES pressure barrier. Hypothesis 3: In healthy individual, in addition to the UES, proximal striated esophagus distal to the area normally incorporated in UES high pressure zone contracts in response to liquid reflux irrespective of secondary peristalsis. This contraction potentially prevents contact of refluxate with UES and provides an added layer of protection against pharyngeal reflux. Hypothesis 4: in patients with SE-GERD and perception of regurgitation associated with true pharyngeal reflux, both UES and sub-sphincteric responses are abnormal. Hypothesis 5: in patients with perception of regurgitation but without entry of refluxate into the pharynx, only the sub-sphincteric contraction will be abnormal.
- Characterization of reflux- induced esophageal motor activity. Hypothesis 6: While in healthy individuals the predominant esophageal response to reflux is secondary peristalsis, in patients with regurgitation and SE-GERD this response is significantly altered and includes simultaneous, segmental contraction, partially propagated or low amplitude secondary peristalsis and absence of motor response.
- Mechanisms of esophago- pharyngeal reflux. Hypothesis 7: pharyngeal reflux occurs when the reflux-induced intra-esophageal pressure exceeds the concurrent UES pressure. This can occur during the following conditions, a. partial UES relaxation, b. complete UES relaxation, c. absence of esophago-UES contractile reflex, d. Belch, e. incomplete swallow and f. excessive intra-esophageal pressure. The investigators will investigate these mechanisms under simulated reflux conditions testing different reflux variables.
- Characterization of UES pressure response to liquid refluxate in asthma patients. Hypothesis 8: UES pressure responses to liquid refluxate are significantly different in patients suffering from asthma compared to healthy controls. Hypothesis 9: these differences are significantly more pronounced during sustained esophageal distensions induced by slow intra-esophageal infusions compared to those due to rapid infusions.
- Characterization of UES pressure response to liquid refluxate at various levels of the esophagus in healthy controls. Hypothesis 10: The UES pressure response is significantly different for various locations of liquid refluxate in the esophagus. Hypothesis 11: the closer the liquid refluxate to the UES, the stronger the response will be.
- Characterization of UES pressure response to liquid refluxate at various levels of the esophagus in GERD patients. Hypothesis 12: The UES pressure response to liquid refluxate at various levels of the esophagus will be significantly different in GERD patients compared to healthy participants. Hypothesis 13: Overall, the UES pressure response to liquid refluxate in GERD patients will be less pronounced than in healthy controls. Hypothesis 14: As the liquid refluxate gets closer to the UES, the UES pressure response to liquid refluxate will increase.
- Characterization of UES and esophageal body response to rapid intra-esophageal air injection after esophageal acid sensitization. Supra-esophageal reflux disease is associated with changing in esophageal reflexes, such as esophago-contractile reflex (EUCR) and esophago-relaxation reflex (EURR). Intra-esophageal rapid injection can trigger EURR. 15: The investigators hypothesize that acid sensitization will affect UES and esophageal body response to rapid air injection. Hypothesis 16:The effect of of UES and esophageal body response to rapid air injection after esophageal acid sensitization will be different in healthy compared to GERD patients.
- Characterization of deglutition before and after intra-esophageal acid or saline infusion. Supra-esophageal reflux disease is associated with changes in deglutitive pressures in UES, esophageal body and LES. The investigators hypothesize that esophageal acidification will affect UES, esophageal body and LES pressures during swallowing. The effect may be different in healthy compared to GERD patients. The investigators also expect to see a difference in parameter's between diseased Barrett's esophagus patients and the healthy population.
- Characterization of deglutition at different phases of the breathing cycle. Typical pattern in healthy adults is swallowing near the end of expiration followed by expiration after swallow. The investigators hypothesize that swallowing at different phases of breathing will affect the UES, esophageal body, and LES pressures during swallowing.
- Characterization of UES pressure response to liquid refluxate at various level of the esophagus in SERD patients. Hypothesis 17: As the liquid refluxate gets closer to the UES, SERD patients will have a lower compensatory response compared to GERD and healthy controls and lower contraction of the proximal striated esophagus (measured by the Pharyngeal Contractile Integral)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- In a heterogeneous group of gastroesophageal reflux disease (GERD) patients, determine and characterize pressure phenomena of the upper esophageal sphincter (UES) incompetence confirmed by concurrent endoscopy.
| Arm | Type | Receives |
|---|---|---|
| GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD) | Active comparator | Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy, Diagnostic Test: Slow and rapid intra-esophageal infusionGERD patients with complaint of regurgitation and one of the following supra-esophageal symptoms attributed to reflux of gastric content: chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis and dental erosion i.e. SE-GERD. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing. |
| Age and gender matched healthy controls | Active comparator | Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy, Diagnostic Test: Slow and rapid intra-esophageal infusionControls will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing. |
| Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint) | Active comparator | Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy, Diagnostic Test: Slow and rapid intra-esophageal infusionAge and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing. |
| Asthma patients with and without supra-esophageal symptoms | Active comparator | Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy, Diagnostic Test: Slow and rapid intra-esophageal infusionAsthma patients with and without supra-esophageal symptoms (these symptoms include chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis, and dental erosion). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing. |
| Age and gender matched patient controls for diagnosed Barrett's esophagus patients | Active comparator | Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy, Diagnostic Test: Slow and rapid intra-esophageal infusionPatient controls for diagnosed Barrett's esophagus patients. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 85
Key exclusion criteria (9 listed)
- Age <18 or >85
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 |
|---|---|---|
| Concurrent manometry/impedance/pH with video pharyngo-laryngoscopyCombined manometric/impedance/pH recording: we will use combined solid-state high-resolution manometry and impedance catheter with 36 circumferential pressure sensors, spaced 1 cm apart, 18 impedance sensor couplets spaced 2 cm apart, 3 pH sensors spaced 7 and 10 cm respectively. The catheter will be introduced trans-nasally. Concurrent video-pharyngo-laryngoscopy: to monitor concurrently the pharynx and larynx for entry of simulated refluxate we will use a laryngo-pharyngo-scope passed through the other nostril and positioned within the pharynx such that the UES inlet, vocal cords and pyriform sinuses are visualized. The laryngo-pharyngo-scope images will be synchronized with manometric/impedance/pH recordings by importing and superimposing the endoscopic images onto high resolution manometric recordings. A specially designed timer will be superimposed on the video images for durational analyses of endoscopic images. | Diagnostic test | Age and gender matched healthy controls, Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint), Age and gender matched patient controls for diagnosed Barrett's esophagus patients, Asthma patients with and without supra-esophageal symptoms, GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD) |
| Slow and rapid intra-esophageal infusionA 3 mm outer diameter injection tube will be placed through the nose in a fashion that the injection port will be located 5-7cm above the manometrically determined upper border of lower esophageal sphincter (LES). With this arrangement gastroesophageal reflux events will be simulated by intra-esophageal injection of body temperature1/2 normal saline (its ionic nature helps impedance recording and identification of intra-esophageal distribution), 0.1 N HCl. Infused liquid will be colored green using food dye for ease of recognition of pharyngeal reflux. Esophageal clearance will be verified by the presence of an effective peristalsis and return of intra-esophageal impedance and pressure to baseline. Endoscopic views of pharynx will be watched carefully during infusions. At the first sign of reflux, perfusion will be stopped, and participants will be instructed to swallow to avoid any potential airway compromise. | Diagnostic test | Age and gender matched healthy controls, Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint), Age and gender matched patient controls for diagnosed Barrett's esophagus patients, Asthma patients with and without supra-esophageal symptoms, GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD) |
Primary outcome
Pressure Data Analysis
Time frame: During simulated reflux perfusion of the esophagus
All pressure measurements will be recorded at a 35HZ frequency and measured in reference to the atmospheric pressure UES and LES pressures will be measured utilizing the e-sleeve function of the manometric analysis software. All UES, LES and esophageal baseline pressures will be measured as peaks and troughs over 3 tidal volume respiratory cycles at stable resting conditions when no pharyngeal, gastric, esophageal, UES or LES events are present. Type, frequency, amplitude, onset, and duration of the UES response along with the LES and esophageal body response will be recorded.
Videoendoscopic data analysis
Time frame: During simulated reflux perfusion of the esophagus
Onset of the entry of colored refluxate into the pharynx though the UES inlet will be determined and correlated with the UES, esophageal and LES pressure phenomena, impedance and pH events. Endoscopic documentation of pharyngeal reflux will be considered the gold standard and impedance and pH data will be compared to it.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- 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.
Reza Shaker, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy and Slow and rapid intra-esophageal infusion in people with GERD, run by Medical College of Wisconsin at 1 site in United States.
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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. 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 States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reza Shaker, MD (4149556840, rshaker@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Data Analysis (time frame: During simulated reflux perfusion of the esophagus). The study lists 2 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 10 Feb 2026.