The LINFU® U.S. Registry for the in the General Population Without Risk Factors
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorAdenocyte, LLC
About this trial
Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions.. In this study, LINFU® will be evaluated in the general population with no risk factors and who exhibit no signs or symptoms of disease, This study will help determine if LINFU® can be used to help identify early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) or their precursor lesions (PanIn-2, PanIn-3).
Eligibility criteria
Qualifiers
Both males and females will be enrolled and must be at least 18 years of age and under age of 90
Patients, who in the opinion of the Investigator, do not exhibit any symptoms of PDAC including jaundice, nausea and vomiting, weight loss, abdominal pain, bloating or the feeling of fullness, itchy skin, lower back pain, light-colored, greasy stools, sudden onset type 2 diabetes, etc.
Patients, who in the opinion of the Investigator, do not have an abnormal imaging study suggestive of PDAC
Patients, who in the opinion of the Investigator, should not be ordinarily screened for PDAC because they do not have risk factors including chronic pancreatitis, family history of PDAC, or genetic cancer syndromes which increase the risk of developing PDAC
Disqualifiers
Patient under the age of 18 and over the age 90
Patient with uncorrectable coagulopathy
Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist
Unstable medically (cardiopulmonary, neurologic, or cardiovascular status)
Trial design
Treatments tested in this trial
- LINFU®
Treatment groups
500 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov