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Image-Guided Herniorrhaphy Study

NCT07267494 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-20

No results posted yet for this study

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Michael Larson, MD · UC Davis Health - Department of Radiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-05-01
Completion
2029-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07267494 on ClinicalTrials.gov