HerniaNCT07267494
Image-Guided Herniorrhaphy Study
A study testing Image-Guided Herniorrhaphy in people with Hernia and Hernia Abdominal Wall, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Hernia Abdominal Wall, Ventral Hernia
- What is being tested?
- Image-Guided Herniorrhaphy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Image-guided Herniorrhaphy Safety and Efficacy Pilot
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
Read the 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
- Being tested
- Image-Guided Herniorrhaphy
- Keywords
- Image-guided herniorrhaphy, hernia, pilot study, quality of life, safety and feasability
- Medical subject headings
- Hernia, Hernia, Abdominal, Hernia, Ventral, Hernia, Inguinal, Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-Guided HerniorrhaphyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Image-Guided Herniorrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through 8 months after the procedure
Secondary outcomes (1)
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.
Measured: Up to 8 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Larson, MD, Principal investigator, UC Davis Health - Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267494
- Sponsor's protocol ID
- 2345685
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-guided Herniorrhaphy Safety and Efficacy Pilot
- ClinicalTrials.gov ID
- NCT07267494
- Acronym / sponsor ID
- 2345685
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Image-Guided Herniorrhaphy | Experimental | Procedure: Image-Guided HerniorrhaphySingle-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-Guided HerniorrhaphyMinimally 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. | Procedure or surgery | Image-Guided Herniorrhaphy |
Primary outcome
Safety of the Image-Guided Herniorrhaphy Procedure
Time frame: Through 8 months after the 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.
Change in Hernia-Related Quality of Life (Short Form-36 Health Survey)
Time frame: Through 8 months after the procedure
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.
Change in Hernia-Specific Quality of Life (Hernia-Related Quality-of-Life Survey)
Time frame: Through 8 months after the procedure
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.
Change in Reflux-Related Quality of Life (GERD-Health-Related Quality of Life Questionnaire)
Time frame: Through 8 months after the procedure
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.
1 secondary outcome
Incidence of Delayed Adhesion-Related Symptoms
Time frame: Up to 8 months after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Click here to learn more and signup for the study!Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Larson, MD principal investigator
UC Davis Health - Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image-Guided Herniorrhaphy in people with Hernia and Hernia Abdominal Wall, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Larson, MD (916-734-6464, mclarson@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the Image-Guided Herniorrhaphy Procedure (time frame: Through 8 months after the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.