NCT07267494

Image-Guided Herniorrhaphy Study

Image-guided Herniorrhaphy Safety and Efficacy Pilot

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Traditional hernia repair requires either open surgical incisions or laparoscopic entry into the abdomen, typically under general anesthesia. Although effective, these operations can be unsuitable for frail or medically complex patients because of anesthesia risks, postoperative pain, and wound complications. This investigator-initiated pilot study explores a minimally invasive alternative: a percutaneous, image-guided herniorrhaphy that uses ultrasound or CT to visualize the hernia and guide placement of a barbed suture through a hollow needle to close the tissue defect. The goal is to assess procedural safety, feasibility, and short-term improvement in hernia-related quality of life. Participants will be adults with reducible abdominal, groin, or hiatal hernias who are not candidates for standard surgery. The study procedure will be performed in the interventional radiology suite using local anesthesia with or without moderate sedation, following existing institutional workflows for other needle-based image-guided procedures. Safety monitoring is provided by two independent physicians-a hernia surgeon and an interventional radiologist-who review study data quarterly and have authority to pause or stop the study if predefined complication criteria are met. Safety events will be categorized using the Society of Interventional Radiology adverse-event classification. This study is intended to generate preliminary data on safety and patient-reported outcomes that can inform future trials of image-guided hernia repair techniques.

Conditions

• Hernia
• Hernia Abdominal Wall
• Ventral Hernia
• Inguinal Hernia
• Hiatal Hernia
• Diastasis Recti

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-01
• Completion: 2029-05-01
• First posted: 2025-12-05
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States