Esophageal Motility DisordersNCT03347903
Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease
An observational study of Esophageal Motility Disorders, run by Medical University of Vienna.
Trial summary
Gastroesophageal reflux disease (GERD) is involved in the development of esophageal motility disorders like Jackhammer esophagus (JE), a novel hypercontractile condition that was associated with progression to achalasia and limited outcomes following surgical anti-reflux therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Motility Disorders
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 May 2017
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: All patients that are referred to our center undergo esophageal high-resolution manometry and ambulatory pH monitoring for screening of gastroesophageal reflux disease and motility disorders. We assess the data that are prospectively obtained. Patients do not have to undergo any interventions.
Who may be able to join
- Patients with symptoms of gastroesophageal reflux disease and diagnosis of Jackhammer esophagus
Who cannot join
- patients not willing to participate data or undergo screening for gastroesophageal reflux disease
About this study
Gastroesophageal reflux disease (GERD) is involved in the development of esophageal motility disorders like Jackhammer esophagus (JE), a novel hypercontractile condition that was associated with progression to achalasia and limited outcomes following surgical anti-reflux therapy.
This trial was designed to assess the prevalence and characteristics of JE in patients with typical symptoms of GERD and responsiveness to PPI therapy.
Read the detailed description
Jackhammer esophagus is a novel hypercontractile esophageal disorder. The investigators assess the prevalence and clinical characteristics of patients diagnosed with this disorder out of a collective of patients that are referred with symptoms of gastroesphageal reflux disease and respond to PPI. This is an observational trial.
- Conditions
- Esophageal Motility Disorders
- Keywords
- esophagus, motility
- Medical subject headings
- Esophageal Motility Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Jackhammer esophagus in patients referred with symptoms of gastroesophageal reflux disease
All patients that are referred to our center with symptoms of gastroesophageal reflux disease routinely undergo high-resolution manometry. We assess how many patients are diagnosed with Jackhammer esophagus
Measured: January 2014- May 2017
Secondary outcomes (2)
Symptom perception
We assess which symptoms are perceived by the patients diagnosed with Jackhammer esophagus. All data are observed during an interview at the high-resolution manometry
Measured: January 2014- May 2017
Prevalence of gastroesophageal reflux disease in patients with Jackhammer esophagus
All patients that are referred to our center are evaluated for gastroesophageal reflux disease. We assess the prevalence of gastroesophageal reflux disease in patients with Jackhammer esophagus diagnosed by ambulatory pH monitoring.
Measured: Januar 2014- May 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Jan 2014
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Motility DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
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
- Investigators
- Sebastian Schoppmann, MD, Principal investigator, Vice Chair of Department of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347903
- Sponsor's protocol ID
- 1164/2017
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kristo I, Schwameis K, Maschke S, Kainz A, Rieder E, Paireder M, Jomrich G, Schoppmann SF. Phenotypes of Jackhammer esophagus in patients with typical symptoms of gastroesophageal reflux disease responsive to proton pump inhibitors. Sci Rep. 2018 Jul 2;8(1):9949. doi: 10.1038/s41598-018-27756-9.
PubMed 29967357
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT03347903
- Acronym / sponsor ID
- 1164/2017
- Conditions
- Esophageal Motility Disorders
- Keywords
- esophagus, motility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 20 Nov 2017 (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.
Gastroesophageal reflux disease (GERD) is involved in the development of esophageal motility disorders like Jackhammer esophagus (JE), a novel hypercontractile condition that was associated with progression to achalasia and limited outcomes following surgical anti-reflux therapy.
This trial was designed to assess the prevalence and characteristics of JE in patients with typical symptoms of GERD and responsiveness to PPI therapy.
Detailed description
Jackhammer esophagus is a novel hypercontractile esophageal disorder. The investigators assess the prevalence and clinical characteristics of patients diagnosed with this disorder out of a collective of patients that are referred with symptoms of gastroesphageal reflux disease and respond to PPI. This is an observational trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients that are referred to our center undergo esophageal high-resolution manometry and ambulatory pH monitoring for screening of gastroesophageal reflux disease and motility disorders. We assess the data that are prospectively obtained. Patients do not have to undergo any interventions.
Key inclusion criteria (1 listed)
- Patients with symptoms of gastroesophageal reflux disease and diagnosis of Jackhammer esophagus
Key exclusion criteria (1 listed)
- patients not willing to participate data or undergo screening for gastroesophageal reflux disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Jackhammer esophagus in patients referred with symptoms of gastroesophageal reflux disease
Time frame: January 2014- May 2017
All patients that are referred to our center with symptoms of gastroesophageal reflux disease routinely undergo high-resolution manometry. We assess how many patients are diagnosed with Jackhammer esophagus
2 secondary outcomes
Symptom perception
Time frame: January 2014- May 2017
Prevalence of gastroesophageal reflux disease in patients with Jackhammer esophagus
Time frame: Januar 2014- May 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Derived from this study: PubMed 29967357Kristo I, Schwameis K, Maschke S, Kainz A, Rieder E, Paireder M, Jomrich G, Schoppmann SF. Phenotypes of Jackhammer esophagus in patients with typical symptoms of gastroesophageal reflux disease responsive to proton pump inhibitors. Sci Rep. 2018 Jul 2;8(1):9949. doi: 10.1038/s41598-018-27756-9.
- Individual participant dataSharing planned: Undecided
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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.
Sebastian Schoppmann, MD principal investigator
Vice Chair of Department of General Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Motility Disorders, run by Medical University of Vienna.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of Jackhammer esophagus in patients referred with symptoms of gastroesophageal reflux disease (time frame: January 2014- May 2017). 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 NCT03347903, which also lists 1 linked publication.
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 21 Nov 2017.