Reduction in Fluoroscopy Radiation Exposure During Lead Implantation for Sacral Neuromodulation: A Randomized Prospective Study
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Fluoroscopy is performed when placing a lead during a sacral neuromodulation procedure. During lead placement, subjects will receive either conventional or experimental fluoroscopic settings. The radiation exposure will be compared between the two groups.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:
• Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.
Locations
United States
California
Loma Linda University Health
RECRUITING
Loma Linda
Contact Information
Primary
Forrest Jellison, MD
fjellison@llu.edu
909 558-2830
Time Frame
Start Date: 2025-08
Estimated Completion Date: 2025-12
Participants
Target number of participants: 44
Treatments
Experimental: Reduced Radiation Fluoroscopy
Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.
Active_comparator: Conventional Fluoroscopy
The standard of care is the conventional fluoroscopy, the C-arm is set at 30 pulses-per-second and the current set as the default.
Related Therapeutic Areas
Sponsors
Leads: Loma Linda University