DialySafe Device LED Light Assessment for Transillumination
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
- Jacksonville, Florida: 21-006758
About this study
The purpose of this research is to gather information on the effectiveness of an innovative device called the “DialySafe” intended to help reduce the chance of needle infiltrations during hemodialysis procedures. The DialySafe concept is a light-based device intended to make the AV fistula and graft easily visible for needle insertion. Light is generated from a red LED embedded in the surface of the device. The device will use transillumination technology to visualize the access, which consists of shining light directly into the skin where blood absorbs some of the light, resulting in a true representation of the location of the vein.
The primary objective of this specific research is to evaluate and adjust the location, angle, type of the LED light placement in DialySafe device to achieve acceptable visibility of fistula or graft. It is important to note that the needle itself will not be inserted using this device under this research protocol.
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:
- Adults age ≥ 18 years.
- End stage renal disease requiring hemodialysis.
- Functional arteriovenous fistula (AVF) or arteriovenous graft (AVG).
Exclusion Criteria:
- Infection of AVF/AVG during last 30 days.
- Erythema and/or swelling of the AVF/AVG.
- Infiltration of the AVF/AVG during last 14 days.
Eligibility last updated 8/16/21. Questions regarding updates should be directed to the study team contact.
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 |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Nabeel Aslam, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available