Image-Guided Herniorrhaphy Study

Официальное название

Image-guided Herniorrhaphy Safety and Efficacy Pilot

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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 po

Первичные конечные точки

• Safety of the Image-Guided Herniorrhaphy Procedure [Срок оценки: Through 8 months after the procedure]
• Change in Hernia-Related Quality of Life (Short Form-36 Health Survey) [Срок оценки: Through 8 months after the procedure]
• Change in Hernia-Specific Quality of Life (Hernia-Related Quality-of-Life Survey) [Срок оценки: Through 8 months after the procedure]
• Change in Reflux-Related Quality of Life (GERD-Health-Related Quality of Life Questionnaire) [Срок оценки: Through 8 months after the procedure]

Вторичные конечные точки (1)

• Incidence of Delayed Adhesion-Related Symptoms [Срок оценки: Up to 8 months after procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UC Davis Health — Sacramento

Идентификаторы

NCT: NCT07267494 · 2345685

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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