Image-Guided Herniorrhaphy Study

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07267494
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Image-Guided Herniorrhaphy — PROCEDURE
    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.

Study Details

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

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
May 1, 2028
Completion
May 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Image-Guided Herniorrhaphy
    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.

Primary Outcome Measure

Safety of the Image-Guided Herniorrhaphy Procedure [ Time Frame: Through 8 months after the procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis HealthSacramentoCalifornia95817-

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By research site
UC Davis Health· Sacramento, CA

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