The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorAdenocyte, LLC
About this trial
Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC.
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, require biopsy to rule out PDAC because they display at least one of the following or both: a) clinical 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. b) one or more imaging studies suggestive of PDAC
All patients must undergo contemporaneous imaging, either within 90 days before the LINFU® procedure or within 30 days after the procedure, with one or more of the following: EUS± FNA, MRI/MRCP, ERCP, CT or CEUS.
Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.
Disqualifiers
Patient under the age of 18 and over the age 90
Contraindications to LINFU®/EUS/ERCP as determined by study investigators: 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)
Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium
Patients who are already known to have PDAC by cytologic or histologic evidence
Trial design
Treatments tested in this trial
- LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas)
Treatment groups
1,000 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov