Image-Guided Herniorrhaphy Study

NCT07267494 | Not Yet Recruiting

• 1 other identifier: 2345685
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Image-guided herniorrhaphy; hernia; pilot study; quality of life; safety and feasability

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Through 8 months after the procedure

Secondary Outcomes (1)

• Incidence of Delayed Adhesion-Related Symptoms

  Up to 8 months after procedure

Study Arms (1)

Image-Guided Herniorrhaphy

EXPERIMENTAL

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

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.

Image-Guided Herniorrhaphy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients that do not fit the diameter of a CT gantry or the weight limit of the procedural CT table
• Patients without insurance or not willing to pay out-of-pocket for the study procedure

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Health

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Hernia; Hernia, Abdominal; Hernia, Ventral; Hernia, Inguinal; Hernia, Hiatal

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hernia, Diaphragmatic; Internal Hernia

Study Officials

• Michael Larson, MD

  UC Davis Health - Department of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Larson, MD

CONTACT

916-734-6464; mclarson@health.ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will undergo a single, image-guided, needle-based herniorrhaphy procedure performed under ultrasound and/or CT guidance with local anesthesia and optional sedation. This pilot is designed to assess procedural safety and changes in hernia-related quality of life to determine feasibility for a larger trial.

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: December 5, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)