Image-Guided Herniorrhaphy Study (NCT07267494) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Image-Guided Herniorrhaphy Study
United States30 participantsStarted 2026-12-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of the Image-Guided Herniorrhaphy Procedure
Timeframe: Through 8 months after the procedure
2
Change in Hernia-Related Quality of Life (Short Form-36 Health Survey)
Timeframe: Through 8 months after the procedure
3
Change in Hernia-Specific Quality of Life (Hernia-Related Quality-of-Life Survey)
Timeframe: Through 8 months after the procedure
4
Change in Reflux-Related Quality of Life (GERD-Health-Related Quality of Life Questionnaire)