GERDNCT00737802
In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter
An observational study of GERD and Barretts Esophagus, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is: To study the components of the gastroesophageal junction high-pressure zone individually and as a group, by pharmacologically eliminating or accentuating the pressure profile generated by the smooth muscle components. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD, Barretts Esophagus
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2013to 3 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal control subjects without GERD and patients with GERD
Who may be able to join
- Symptomatic heartburn
- Regurgitation
- Chest pain or water brash
Who cannot join
- Medications-Subjects on any medication which could effect the gastroesophageal junction high-pressure zone will be excluded, this includes use of antacids, H2 blockers, proton pump inhibitors, prokinetic agents, erythromycin type antibiotics and anticholinergics.
- GI symptoms, conditions and disorders
- In addition exclusion criteria will include a history of:
- Esophagitis
- Gastrointestinal symptoms such as abdominal pain
- Heartburn
Show all 19Show fewer
- Reflux
- Regurgitation
- Chest pain
- Difficulty swallowing
- Pain on swallowing
- Dysphagia
- Abdominal surgery involving the stomach or esophagus
- Nausea or vomiting
- Diabetes
- Scleroderma
- Esophageal motility disorders
- Non cardiac chest pain
- Achalasia and current pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
LIJ Medical Center- NSLIJ Health System
New Hyde Park, New York, 11040
About this study
The purpose of this study is:
- To study the components of the gastroesophageal junction high-pressure zone individually and as a group, by pharmacologically eliminating or accentuating the pressure profile generated by the smooth muscle components.
- To differentiate the gastric sling fibers from the clasp fibers based on the spatial orientation of these muscle groups.
Read the detailed description
The purpose of this research study is to examine and evaluate a part of the digestive system (gastrointestinal tract). The specific part the study team will look at is called the "lower esophageal sphincter complex." This complex is located where the esophagus (food pipe) meets the top of the stomach. The lower esophageal sphincter complex involves a group of muscles, and the study team hopes to better understand how they work.
The study team hopes that, by studying the lower esophageal sphincter complex, it may be possible to discover how it functions and what causes it to fail. When a complex fails, this can lead to reflux and heartburn. So learning more about the lower esophageal complex may help doctors' better treat future patients with reflux problems.
We plan to study these functions in normal control subjects, in patients with GERD (heartburn symptoms), and in patients with Barrett's esophagus (a change in the lining of the esophagus due to chronic reflux). The doctor performing the study procedure has previous experience with and is skilled in performing these procedures.
- Conditions
- GERD, Barretts Esophagus
- Keywords
- GERD, Heartburn, Esophageal reflux, Barretts esophagus, Normal subjects
- Medical subject headings
- Gastroesophageal Reflux, Barrett Esophagus, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Control | Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD | |
| GERD Patients | GERD patients are those with history of GERD, signs and symptoms of GERD and selected signs and symptoms of GERD in the questionnaire. | |
| Barrett's patients | Barrett's patients are those participants who in addition to all the qualities of GERD patients have long standing history of GERD and mucosal changes in the esophagus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure at the gastric sling and clasp fibers
esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study start12 Apr 2013
- Primary completion9 Apr 2015
- Study completion3 Feb 2017
Why it stopped: Was not able to recruit the total anticipated number of subjects
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.
- More trials run by Northwell HealthThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Miller, Northwell Health
- Investigators
- Larry S Miller, MD, Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737802
- Sponsor's protocol ID
- R01DK059500
- Status last verified
- Feb 2019
- First submitted
- 18 Aug 2008
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter
- ClinicalTrials.gov ID
- NCT00737802
- Acronym / sponsor ID
- R01DK059500
- Conditions
- GERD, Barretts Esophagus
- Keywords
- GERD, Heartburn, Esophageal reflux, Barretts esophagus, Normal subjects
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Was not able to recruit the total anticipated number of subjects
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 12 Apr 2013 (actual)
- Primary completion
- 9 Apr 2015 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 20 Aug 2008 (estimated)
- 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 purpose of this study is:
- To study the components of the gastroesophageal junction high-pressure zone individually and as a group, by pharmacologically eliminating or accentuating the pressure profile generated by the smooth muscle components.
- To differentiate the gastric sling fibers from the clasp fibers based on the spatial orientation of these muscle groups.
Detailed description
The purpose of this research study is to examine and evaluate a part of the digestive system (gastrointestinal tract). The specific part the study team will look at is called the "lower esophageal sphincter complex." This complex is located where the esophagus (food pipe) meets the top of the stomach. The lower esophageal sphincter complex involves a group of muscles, and the study team hopes to better understand how they work.
The study team hopes that, by studying the lower esophageal sphincter complex, it may be possible to discover how it functions and what causes it to fail. When a complex fails, this can lead to reflux and heartburn. So learning more about the lower esophageal complex may help doctors' better treat future patients with reflux problems.
We plan to study these functions in normal control subjects, in patients with GERD (heartburn symptoms), and in patients with Barrett's esophagus (a change in the lining of the esophagus due to chronic reflux). The doctor performing the study procedure has previous experience with and is skilled in performing these procedures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Control | – | –Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD |
| GERD Patients | – | –GERD patients are those with history of GERD, signs and symptoms of GERD and selected signs and symptoms of GERD in the questionnaire. |
| Barrett's patients | – | –Barrett's patients are those participants who in addition to all the qualities of GERD patients have long standing history of GERD and mucosal changes in the esophagus. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal control subjects without GERD and patients with GERD
Key inclusion criteria (3 listed)
- Symptomatic heartburn
- Regurgitation
- Chest pain or water brash
Key exclusion criteria (19 listed)
- Medications-Subjects on any medication which could effect the gastroesophageal junction high-pressure zone will be excluded, this includes use of antacids, H2 blockers, proton pump inhibitors, prokinetic agents, erythromycin type antibiotics and anticholinergics.
- GI symptoms, conditions and disorders
- Esophagitis
- Gastrointestinal symptoms such as abdominal pain
- Heartburn
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
Pressure at the gastric sling and clasp fibers
Time frame: 5 years
esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers
Results and safety
The study was stopped early (reason given: Was not able to recruit the total anticipated number of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry S Miller, MD principal investigator
Feinstein Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD and Barretts Esophagus, run by Northwell Health 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 3 inclusion and 19 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: stopped early, as of the sponsor's last update on 22 Feb 2019. 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?
The study was stopped early (reason given: Was not able to recruit the total anticipated number of subjects). 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?
Pressure at the gastric sling and clasp fibers (time frame: 5 years). 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 22 Feb 2019.