About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Image-Guided Herniorrhaphy