Clinical Trials

Inclusion Criteria - Pancreatic Mass Subjects:

• Male or female patients that have been diagnosed with a pancreatic mass and/or Pancreatic Cancer via one of the following methods:
  • Computed tomography (CT);
  • Endoscopic ultrasound (EUS);
  • Magnetic resonance imaging (MRI);
  • Fine Needle Aspiration (FNA) Biopsy;
  • Brush Biopsy;
  • Laparoscopy.
• At least 45 years of age.
• Negative urine pregnancy test at screening, if applicable.
• In the Investigator’s judgment, subject is mentally competent to provide informed consent to participate in the study.

Inclusion Criteria – Healthy Control Subjects:

• Male or female subjects undergoing colonoscopy for routine clinical indications to include colon cancer screening or polyp surveillance.
• At least 45 years of age.
• Negative urine pregnancy test at screening, if applicable.
• In the investigator’s judgement, subject is mentally competent to provide informed consent to participate in the study.

Exclusion Criteria:

• The subject or investigator feels the subject will be unable to complete the bowel preparation.
• If Applicable: The pancreatic mass under evaluation has been previously determined to be a pseudocyst or otherwise benign mass.
• If Applicable: The pancreatic mass under evaluation has been previously determined to be malignant AND the subject is currently undergoing chemotherapy or radiation therapy.
• Subjects with any past diagnosis of non-Pancreatic cancer.
  • NOTE: Subjects previously diagnosed and treated for cancerous skin lesions may be considered for study inclusion.
• Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon that would put them at risk during bowel preparation.
• Subjects who, in the opinion of the Principal Investigator, have uncontrolled clinically significant pre-existing electrolyte disturbances (such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia or dehydration) that would put them at risk during bowel preparation.
• Subjects who are pregnant or lactating, or intending to become pregnant during the study.
• Subjects of childbearing potential who refuse a pregnancy test.
• Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
• Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
  • NOTE: Subjects participating in observational or diagnostic studies may be considered for inclusion.