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Image-Guided Herniorrhaphy Study
Sponsor: University of California, Davis
Summary
This pilot clinical study will evaluate the safety and effectiveness of a new image-guided, needle-based approach for repairing abdominal or groin hernias in adults who are unable or unwilling to undergo traditional open or laparoscopic surgery. The technique uses ultrasound and, when needed, CT imaging to guide a hollow needle preloaded with barbed suture through the skin to close the hernia defect without large incisions or general anesthesia. Each participant will undergo one image-guided procedure and will be followed for eight months to assess complications and changes in hernia-related quality of life. Approximately thirty participants will be enrolled. The study aims to determine whether this minimally invasive approach is safe, feasible, and capable of improving hernia symptoms enough to justify a larger clinical trial
Official title: Image-guided Herniorrhaphy Safety and Efficacy Pilot
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-05-01
Completion Date
2029-05-01
Last Updated
2026-03-20
Healthy Volunteers
No
Interventions
Image-Guided Herniorrhaphy
Minimally invasive, image-guided repair of abdominal or groin hernias. Under ultrasound (primary) and, when indicated, low-dose CT guidance, a hollow needle preloaded with bi-directional barbed suture is passed percutaneously across the defect to approximate and secure tissue without surgical incisions or general anesthesia. The procedure is performed in the interventional radiology suite with local anesthesia and optional moderate IV sedation; typical procedure time \~30-60 minutes. Standard post-procedure monitoring is completed prior to discharge. Arm/Intervention Link: Applied to the "Image-Guided Herniorrhaphy" (Experimental) arm.
Locations (1)
UC Davis Health
Sacramento, California, United States