Image-Guided Herniorrhaphy Study

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

Inclusion Criteria: * English-speaking adult with reducible hernia(s) or diastasis smaller than approximately 8 cm seeking treatment for their hernia but not able or willing to undergo traditional surgery (open, laparoscopic, or robotic) * Patient must be willing to undergo a novel 30- to 60-minute image-guided needle-based procedure Exclusion Criteria: * Children, prisoners, and pregnant women (possibly requiring a pregnancy test on the day of the procedure) * Patients with a known reaction to local anesthetic or sedation medications or the suture material to be used * Patients with irreducible hernias * Patients with herniation not visible by ultrasound or CT * Patients that do not fit the diameter of a CT gantry or the weight limit of the procedural CT table * Patients without insurance or not willing to pay out-of-pocket for the study procedure