Pretest of Alfapump® Patient Preference Discrete-choice Experiment
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-005021
- Scottsdale/Phoenix, Arizona: 21-005021
About this study
The overall objective of the patient preference evaluation is to understand how patients tradeoff the benefits and risks of the alfapump related to the primary endpoints of the current POSEIDON clinical trial in support of future marketing application.
The alfapump system is designed to reduce or eliminate the need for therapeutic paracentesis and to provide relief from symptoms of tense ascites with its attendant effects on patient quality of life (QOL) and nutrition. fits and risks of the alfapump related to the primary endpoints of the current POSEIDON clinical trial in support of future marketing application.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Male and female patients, ≥ 18 years of age
- Cirrhosis of liver defined by histological and/or clinical, endoscopic, laboratory and radiological criteria.
- Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis.
- Not a candidate for (refused, contraindicated) TIPS or previously implanted TIPS is permanently obstructed or non-functioning.
- Life expectancy of at least 6 months.
- Capable of giving written informed consent and able to understand and complete the survey in English.
Exclusion Criteria:
- Patients that have lost the ability to understand the meaning or importance of something and the ability to talk or write, resulting in the inability to live independently.
Therapeutic Paracentesis is defined as removal of at least 1.5L of ascitic fluid by means of percutaneous drainage with therapeutic intent in patients with symptoms related to fluid accumulation or clear evidence of ascites accumulation (weight gain, abdominal circumference), excluding patients receiving a puncture for diagnostic purpose only.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Patrick Kamath, M.D. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Hugo Vargas, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available