02/28/2024
Light Line Medical is looking for volunteers who are PD patients.
Peritoneal Dialysis (PD) Patients with 3 months of PD experience or Experienced PD Nurses and PD Technicians may participate! Eligible participants will be provided with information about the Light Line PhotoDisinfection System™, asked to complete simulated user tasks, and then provide feedback. Participants will complete a single one-to-two-hour training session, be given a 1-hour break, and a one-to-two-hour simulation test session.
Why is this study being conducted?
Usability studies are a form of research required by the FDA and other regulatory agencies to find out whether a product and its instructions are safe and effective for use. The best way to evaluate is to have people like you work with the study device under simulated use conditions (using a mannequin) and talk about your experience. Light Line Medical’s Photo-Disinfection System (PD System) was developed using visible light-based disinfection to reduce infection risk in peritoneal dialysis by effectively preventing air and touch contamination at the dialysate exchange hub and maintaining a sterile dialysis fluid path.
What does the study involve?
Interested participants may contact a member of the study team to learn more and prescreen for eligibility.
Eligible individuals wishing to participate after learning about the study may be scheduled for an in-person visit at the study site to provide informed consent and begin participation.
On the scheduled in-person visit day:
- Upon arrival, participants will be asked to review the informed consent and will be given the opportunity to ask questions.
- Following consent, participants will be provided training on how to use the device, in which participants are permitted to ask any questions related to use.
- Upon the completion of training, participants will be provided with a minimum of a 1-hour break. Upon return, participants will be asked to perform simulated tasks involving the device.
Data will be collected via survey instruments, interviews, and video-recorded observation.
Participants who complete the study will be monetarily compensated (minimum ~$150) for their time and effort.
Who is eligible to participate in the study?
Eligible participants include peritoneal patients with 3 months of PD catheter use experience or medical professionals (nurse or PCT) with 1 year of PD catheter use experience. Must be between 18-75 years old. All participants must be able to read and understand the English language.
How can I find out more about the study?
Contact: Kari Haab - haab@lightlinemedical.com,
or call (734) 646-3296
