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
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Safety of the Image-Guided Herniorrhaphy Procedure
Timeframe: Through 8 months after the procedure
Change in Hernia-Related Quality of Life (Short Form-36 Health Survey)
Timeframe: Through 8 months after the procedure
Change in Hernia-Specific Quality of Life (Hernia-Related Quality-of-Life Survey)
Timeframe: Through 8 months after the procedure
Change in Reflux-Related Quality of Life (GERD-Health-Related Quality of Life Questionnaire)
Timeframe: Through 8 months after the procedure