The overall objective of this study is to determine if there are pyloric sphincter abnormalities in patients with gastroparesis symptoms and determine how prevalent these abnormalities are using tests to assess the pyloric sphincter - endoluminal functional luminal imaging probe (Endoflip™), water load satiety testing (WLST), and high-resolution cutaneous electrogastrography (HR-EGG) using Gastric Alimetry™ System.
Study Description: This is a multi-center, prospective, observational study to assess pyloric sphincter abnormalities in patients with symptoms of gastroparesis (both delayed and normal gastric emptying) and control participants without symptoms of gastroparesis using the commercially available, FDA approved endoluminal functional luminal imaging probe (Endoflip™) catheter, which measures diameter, cross-sectional area, pressure, compliance, and distensibility of gastrointestinal sphincter muscles. This study will assess lower esophageal and pyloric sphincter diameter, CSA, pressure, distensibility, and compliance in patients with symptoms of gastroparesis and delayed gastric emptying, patients with symptoms of gastroparesis but with normal gastric emptying, and normal control participants. The protocol will also include a water load satiety test and use Gastric Alimetry™ System that assesses gastric myoelectrical activity in symptomatic participants but not control participants.
Study Type
OBSERVATIONAL
Enrollment
150
Mayo Clinic Arizona
Scottsdale, Arizona, United States
NOT_YET_RECRUITINGUniversity of Louisville
Louisville, Kentucky, United States
RECRUITINGMassachusetts General
Boston, Massachusetts, United States
RECRUITINGWake Forest University Health Sciences
Winston-Salem, North Carolina, United States
RECRUITINGTemple University
Philadelphia, Pennsylvania, United States
RECRUITINGTexas Tech University Health Science Center (TTUHSC)
El Paso, Texas, United States
NOT_YET_RECRUITINGDistensibility of the pylorus
Distensibility of the pylorus will be calculated as the median of three measurements (not three different inflations) of distensibility (mm2/mmHg) of the pylorus pressure using the Endoflip balloon catheter at 50 mL volume
Time frame: Baseline
Opening diameter (mm) of the pylorus when 40 mL volume is introduced into the EF325N Endoflip™ measurement catheter.
diameter (mm) of the pylorus
Time frame: Baseline
Opening diameter (mm) of the pylorus when 50 mL volume is introduced into the EF325N Endoflip™ measurement catheter.
diameter (mm) of the pylorus
Time frame: Baseline
Cross Sectional Area(mm2) of the pylorus with 40 mL balloon volume
Cross Sectional Area (mm2) of the pylorus
Time frame: Baseline
Cross Sectional Area(mm2) of the pylorus with 50 mL balloon volume
Cross Sectional Area (mm2) of the pylorus
Time frame: Baseline
Compliance (mm3/mmHg) of the pylorus with 40 mL balloon volume
Compliance (mm3/mmHg) of the pylorus
Time frame: Baseline
Compliance (mm3/mmHg) of the pylorus with 50 mL balloon volume
Compliance (mm3/mmHg) of the pylorus
Time frame: Baseline
Pressure (mmHg) of the pyloric sphincter
Pressure (mmHg) of the pyloric sphincter
Time frame: Baseline
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