An interventional study of Image-Guided Herniorrhaphy in Hernia, Hernia Abdominal Wall and Ventral Hernia, sponsored by University of California, Davis. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
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
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.
257 studies on the registry are indexed under Hernia; 37 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 167 interventional studies indexed under Hernia.
Browse Hernia studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
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Exclusion Criteria:
Single-arm pilot. All participants undergo a percutaneous, image-guided needle-based hernia repair performed under ultrasound and/or CT guidance with local anesthesia and optional moderate sedation. Follow-up includes clinic visits and quality-of-life assessments over \~8 months.
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.
Safety of the Image-Guided Herniorrhaphy Procedure
Frequency, type, and severity of all procedure-related adverse events, categorized according to the Society of Interventional Radiology (SIR) Adverse Event Classification. Major complications (e.g., bleeding, bowel injury, infection, or events requiring hospitalization \>48 hours) and minor complications will be recorded and reviewed by independent safety monitors.
Time frame: Through 8 months after the procedure
Change in Hernia-Related Quality of Life (Short Form-36 Health Survey)
Mean change in general health-related quality-of-life scores measured using the Short Form-36 (SF-36) Health Survey, a validated 36-item measure assessing eight domains of physical and mental health. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Through 8 months after the procedure
Change in Hernia-Specific Quality of Life (Hernia-Related Quality-of-Life Survey)
Mean change in hernia-specific quality-of-life scores measured using the Hernia-Related Quality-of-Life Survey (HerQLes), a validated 12-item instrument used for ventral and abdominal wall hernias. Scores range from 0 to 100, with higher scores indicating better hernia-related quality of life.
Time frame: Through 8 months after the procedure
Change in Reflux-Related Quality of Life (GERD-Health-Related Quality of Life Questionnaire)
Mean change in symptom severity and quality-of-life scores measured using the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire, a validated 10-item scale used in patients with hiatal hernias. Scores range from 0 to 75, with higher scores indicating worse reflux symptoms and lower quality of life.
Time frame: Through 8 months after the procedure
Incidence of Delayed Adhesion-Related Symptoms
Number of participants reporting new or worsening abdominal pain, nausea, vomiting, or bowel obstruction potentially related to intra-abdominal adhesions, assessed via follow-up visits and phone calls.
Time frame: Up to 8 months after procedure
Plan to share: No
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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