GastroparesisPyloEndoFlipNCT02446119
Pyloric Sphincter Pressure and Geometry Assessment Using EndoFlip
An observational study of Gastroparesis, run by Temple University at 1 site in United States.
Trial summary
Gastroparesis is a disorder characterized by symptoms from gastric retention in the absence of mechanical obstruction. Gastric emptying is a highly regulated process reflecting the integration of the propulsive forces of proximal fundic tone and distal antral contractions with the functional resistance provided by the… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- What is being tested?
- EndoFLIP
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inclusion criteria: 1. Subjects will be of either sex, 18 to 70 years of age. 2. Two groups will be recruited. 2a. First, patients with an established diagnosis of gastroparesis, either diabetic or idiopathic etiology. The gastroparesis subjects will have delayed gastric emptying on gastric scintigraphy defined as greater than 60% retention at 2 hours and/or greater than 10% retention at 4 hours. 2b. Second, control subjects will be nondiabetic patients without gastroparesis or gastroesophageal reflux symptoms undergoing upper endoscopy.
Who may be able to join
- Subjects will be of either sex, 18 to 70 years of age.
- Two groups will be recruited:
- First, patients with an established diagnosis of gastroparesis, either diabetic or idiopathic etiology.
- Second, control subjects will be nondiabetic patients without gastroparesis or gastroesophageal reflux symptoms undergoing upper endoscopy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Henry P. Parkman, MD, 215-707-3431, henry.parkman@temple.edu
Henry P. Parkman, MD
About this study
Gastroparesis is a disorder characterized by symptoms from gastric retention in the absence of mechanical obstruction. Gastric emptying is a highly regulated process reflecting the integration of the propulsive forces of proximal fundic tone and distal antral contractions with the functional resistance provided by the pyloric sphincter. Pylorospasm has been reported in some patients with gastroparesis. This study protocol will assess pyloric sphincter pressure and geometry in patients with gastroparesis and control subjects without symptoms of gastroparesis. The commercially available FDA approved endoscopic functional luminal imaging probe (EndoFLIP) catheter will be used, which measures diameter, pressure, length, and distensibility of gastrointestinal sphincter muscles along the balloon distance. It is used to measure the pressure characteristics of the lower esophageal sphincter during bariatric surgery for obesity, during Heller myotomy for achalasia, and during Nissen fundoplication for gastroesophageal reflux disease. In this study, during upper endoscopy, which is routinely performed under sedation, patients with gastroparesis and controls without gastroparesis symptoms will have their pyloric sphincter assessed with EndoFLIP. After passage of the endoscope into the stomach, the EndoFLIP catheter will be introduced alongside the endoscope and advanced through the pyloric sphincter as visualized endoscopically. The investigators will measure the pressure and contour of the pyloric sphincter using three successive volume distensions of the EndoFLIP balloon (20 ml, 30 ml, 40 ml). The investigators will compare the results between the gastroparesis patients and the control patients without gastroparesis. Through this study, the investigators will better understand the abnormalities of the pyloric sphincter in patients with gastroparesis.
Read the detailed description
This study protocol will assess pyloric sphincter pressure and geometry in patients with gastroparesis and control subjects without symptoms of gastroparesis.
Aims: To determine if there is a subgroup of patients with gastroparesis who have pressure and/or geometric configuration abnormalities of the pyloric sphincter. We will determine this by assessing the pressure, diameter, length, and distensibility of the pyloric sphincter in patients with gastroparesis and in subjects without gastroparesis undergoing upper endoscopy for their clinical evaluation.
Hypothesis:The pylorus of patients with gastroparesis has a higher pressure, smaller diameter, and is less distensible than the pylorus of control patients without gastroparesis
Methods: The commercially available FDA approved endoscopic functional luminal imaging probe (EndoFLIP) catheter will be used, which measures diameter, pressure, length, and distensibility of gastrointestinal sphincter muscles along the balloon distance. It is used to measure the pressure characteristics of the lower esophageal sphincter during bariatric surgery for obesity, during Heller myotomy for achalasia, and during Nissen fundoplication for gastroesophageal reflux disease. In this study, during upper endoscopy, which is routinely performed under sedation, patients with gastroparesis and controls without gastroparesis symptoms will have their pyloric sphincter assessed with EndoFLIP. After passage of the endoscope into the stomach, the EndoFLIP catheter will be introduced alongside the endoscope and advanced through the pyloric sphincter as visualized endoscopically. The investigators will measure the pressure and contour of the pyloric sphincter using three successive volume distensions of the EndoFLIP balloon (20 ml, 30 ml, 40 ml). The assessment of the pylorus will be done during the upper endoscopy which will take approximately 60 minutes. We will compare the pyloric pressure measurements in patients with gastroparesis to the control patients. This is an observational study, with no intervention.
Analysis: The investigators will compare the results between the gastroparesis patients and the control patients without gastroparesis.
Through this study, the investigators will better understand the abnormalities of the pyloric sphincter in patients with gastroparesis.
- Conditions
- Gastroparesis
- Being tested
- EndoFLIP
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoFLIPDevice
Measurement of pyloric resistance and compliance
| Study group | Role | What they receive |
|---|---|---|
| Gastroparesis | Inclusion criteria:
1. Subjects will be of either sex, 18 to 70 years of age.
patients with an established diagnosis of gastroparesis, either diabetic or idiopathic etiology. The gastroparesis subjects will have delayed gastric emptying on gastric scintigraphy defined as greater than 60% retention at 2 hours and/or greater than 10% retention at 4 hours. This gastric emptying test would have been done prior to the endoscopy and is not part of the research study. Patients will undergo EndoFlip during upper endoscopy. Receives: Device: EndoFLIP | |
| Normals | Inclusion criteria:
1. Subjects will be of either sex, 18 to 70 years of age.
control subjects will be nondiabetic patients without gastroparesis or gastroesophageal reflux symptoms undergoing upper endoscopy. Patients will undergo EndoFlip during upper endoscopy. Receives: Device: EndoFLIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pyloric pressure
Measurement of pyloric pressure using EndoFLIP in patients with gastroparesis and controls. Our plan is to compare the pyloric pressures in patients with gastroparesis to controls. This is an observational study with no intervention.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry P Parkman, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446119
- Sponsor's protocol ID
- 21560
- Acronym
- PyloEndoFlip
- Status last verified
- Aug 2020
- First submitted
- 9 May 2015
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyloric Sphincter Pressure and Geometry Assessment Using EndoFlip
- ClinicalTrials.gov ID
- NCT02446119
- Acronym / sponsor ID
- PyloEndoFlip / 21560
- Conditions
- Gastroparesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 18 May 2015 (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.
Gastroparesis is a disorder characterized by symptoms from gastric retention in the absence of mechanical obstruction. Gastric emptying is a highly regulated process reflecting the integration of the propulsive forces of proximal fundic tone and distal antral contractions with the functional resistance provided by the pyloric sphincter. Pylorospasm has been reported in some patients with gastroparesis. This study protocol will assess pyloric sphincter pressure and geometry in patients with gastroparesis and control subjects without symptoms of gastroparesis. The commercially available FDA approved endoscopic functional luminal imaging probe (EndoFLIP) catheter will be used, which measures diameter, pressure, length, and distensibility of gastrointestinal sphincter muscles along the balloon distance. It is used to measure the pressure characteristics of the lower esophageal sphincter during bariatric surgery for obesity, during Heller myotomy for achalasia, and during Nissen fundoplication for gastroesophageal reflux disease. In this study, during upper endoscopy, which is routinely performed under sedation, patients with gastroparesis and controls without gastroparesis symptoms will have their pyloric sphincter assessed with EndoFLIP. After passage of the endoscope into the stomach, the EndoFLIP catheter will be introduced alongside the endoscope and advanced through the pyloric sphincter as visualized endoscopically. The investigators will measure the pressure and contour of the pyloric sphincter using three successive volume distensions of the EndoFLIP balloon (20 ml, 30 ml, 40 ml). The investigators will compare the results between the gastroparesis patients and the control patients without gastroparesis. Through this study, the investigators will better understand the abnormalities of the pyloric sphincter in patients with gastroparesis.
Detailed description
This study protocol will assess pyloric sphincter pressure and geometry in patients with gastroparesis and control subjects without symptoms of gastroparesis.
Aims: To determine if there is a subgroup of patients with gastroparesis who have pressure and/or geometric configuration abnormalities of the pyloric sphincter. We will determine this by assessing the pressure, diameter, length, and distensibility of the pyloric sphincter in patients with gastroparesis and in subjects without gastroparesis undergoing upper endoscopy for their clinical evaluation.
Hypothesis:The pylorus of patients with gastroparesis has a higher pressure, smaller diameter, and is less distensible than the pylorus of control patients without gastroparesis
Methods: The commercially available FDA approved endoscopic functional luminal imaging probe (EndoFLIP) catheter will be used, which measures diameter, pressure, length, and distensibility of gastrointestinal sphincter muscles along the balloon distance. It is used to measure the pressure characteristics of the lower esophageal sphincter during bariatric surgery for obesity, during Heller myotomy for achalasia, and during Nissen fundoplication for gastroesophageal reflux disease. In this study, during upper endoscopy, which is routinely performed under sedation, patients with gastroparesis and controls without gastroparesis symptoms will have their pyloric sphincter assessed with EndoFLIP. After passage of the endoscope into the stomach, the EndoFLIP catheter will be introduced alongside the endoscope and advanced through the pyloric sphincter as visualized endoscopically. The investigators will measure the pressure and contour of the pyloric sphincter using three successive volume distensions of the EndoFLIP balloon (20 ml, 30 ml, 40 ml). The assessment of the pylorus will be done during the upper endoscopy which will take approximately 60 minutes. We will compare the pyloric pressure measurements in patients with gastroparesis to the control patients. This is an observational study, with no intervention.
Analysis: The investigators will compare the results between the gastroparesis patients and the control patients without gastroparesis.
Through this study, the investigators will better understand the abnormalities of the pyloric sphincter in patients with gastroparesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastroparesis | – | Device: EndoFLIPInclusion criteria: 1. Subjects will be of either sex, 18 to 70 years of age. patients with an established diagnosis of gastroparesis, either diabetic or idiopathic etiology. The gastroparesis subjects will have delayed gastric emptying on gastric scintigraphy defined as greater than 60% retention at 2 hours and/or greater than 10% retention at 4 hours. This gastric emptying test would have been done prior to the endoscopy and is not part of the research study. Patients will undergo EndoFlip during upper endoscopy. |
| Normals | – | Device: EndoFLIPInclusion criteria: 1. Subjects will be of either sex, 18 to 70 years of age. control subjects will be nondiabetic patients without gastroparesis or gastroesophageal reflux symptoms undergoing upper endoscopy. Patients will undergo EndoFlip during upper endoscopy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion criteria: 1. Subjects will be of either sex, 18 to 70 years of age. 2. Two groups will be recruited. 2a. First, patients with an established diagnosis of gastroparesis, either diabetic or idiopathic etiology. The gastroparesis subjects will have delayed gastric emptying on gastric scintigraphy defined as greater than 60% retention at 2 hours and/or greater than 10% retention at 4 hours. 2b. Second, control subjects will be nondiabetic patients without gastroparesis or gastroesophageal reflux symptoms undergoing upper endoscopy.
Key inclusion criteria (4 listed)
- Subjects will be of either sex, 18 to 70 years of age.
- Two groups will be recruited:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EndoFLIPMeasurement of pyloric resistance and compliance | Device | Gastroparesis, Normals |
Primary outcome
Pyloric pressure
Time frame: 60 minutes
Measurement of pyloric pressure using EndoFLIP in patients with gastroparesis and controls. Our plan is to compare the pyloric pressures in patients with gastroparesis to controls. This is an observational study with no intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
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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.
Henry P Parkman, MD principal investigator
Temple University
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 Gastroparesis, run by Temple University 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 4 inclusion and 0 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 17 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henry P. Parkman, MD (215-707-9900, henry.parkman@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pyloric pressure (time frame: 60 minutes). 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 17 Aug 2020.