AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE

Обзор

The primary purpose of this clinical trial is to assess the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair. The study will evaluate whether ECLIPSIUM, a bioresorbable polymer-based fixation device, is effective in reducing the risk of hernia recurrence when compared with bioresorbable tacks. This information will support understanding of ECLIPSIUM's potential clinical benefits in ventral hernia repair.

Подробное описание

A prospective, multi-center, randomized, active control, single-blind non- inferiority study designed to evaluate the safety and effectiveness of the ECLIPSIUM® System versus bioresorbable tacks in mesh fixation in patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair procedures.

Вмешательства

• Устройство ECLIPSIUM® System
  The ECLIPSIUM® System functions by applying a biodegradable, implantable polymer coating to the prosthetic material under guidance of a template to ensure appropriate application, followed by in situ photo-activation using the TISSIUM curing light to secure the mesh to the abdominal wall.
• Устройство Resorbable tacks (AbsorbaTack/SorbaFix)
  Resorbable tacks are surgical fasteners used to secure a hernia mesh in place. Resorbable tacks are designed to be absorbed by the body over time, gradually losing strength as the tissue ingrowth into the mesh occurs and takes over the support function.

Первичные конечные точки

• Hernia Recurrence at 6 months [Срок оценки: 6 months]
• Cumulative Incidence of Complications [Срок оценки: 12 months]

Вторичные конечные точки (1)

• Hernia Recurrence at 12 months [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Patient is 22 years old or older.
• Patient is willing and able to provide a signed Patient Informed Consent Form.
• Patient has a single midline primary ventral, umbilical, or incisional hernia;

a.Hernia Size is 1 -5 cm in diameter (to be confirmed intraoperatively).

• Patient is scheduled for a laparoscopic IPOM hernia repair.
• Hernia can be successfully repaired with a single polyester or polypropylene composite mesh with biodegradable coating with at least a 5 cm overlap of the mesh on all sides of the defect (to be confirmed intraoperatively).
• Female patients must:

• Have a negative urine pregnancy test within 3 days before surgery and agree to consistently use an effective method of contraception through completion of study participation.

OR

• Have reached menopause (no menses for 1 year). OR
• Have undergone hysterectomy, bilateral oophorectomy, or tubal ligation.
• Patient is willing and able to follow the study instructions including completion of study procedures, assessments, and visits.

Критерии исключения

• Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, comparator device, mesh, or other surgical products (e.g., sutures).
• Patient is taking systemic photosensitivity pharmaceutical products at time of informed consent.
• Patient has a BMI > 40.
• Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day.
• Patient's hernia is recurrent and/or the patient has a previous midline primary ventral, umbilical, or incisional hernia repair with mesh implantation.
• Patient has a life expectancy less than 1 year, in the opinion of the Investigator.
• Patient is unwilling or unable to follow postoperative instructions.
• Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent.
• Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding.
• Patient has a diagnosis of Type 1 Diabetes Mellitus.
• Patient has uncontrolled Type 2 Diabetes Mellitus (HbA1C ≥ 7.0 within 3 months preceding study enrolment).
• Patient is currently participating in an investigational drug or device study that has not completed the primary outcome or that clinically interferes with this clinical study's outcome (Note: Studies requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational studies).
• Patient has more than one hernia defect (single hernia defect between 1-5 cm in diameter from outer edged to outer edge to be confirmed intraoperatively).
• Patient has areas of weakness, independent from the hernia to be treated, in the area covered by mesh or mesh-adjacent tissues (to be confirmed intraoperatively).
• Patient with a complex hernia, likely not eligible for laparoscopic repair, as determined by the Investigator (ex. small bowel resection; to be confirmed intraoperatively).
• Patient is scheduled for an additional surgery within 6 weeks after the index-procedure or has undergone surgery within 90 days before the index-procedure.
• Patient has severe chronic obstructive pulmonary disease.
• Patient has an ongoing infection (e.g. elevated temperature, elevated white blood count).
• In the opinion of the Investigator, the patient is not a suitable candidate for the clinical investigation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 12 центров

• VA Loma Linda — Loma Linda
• University of Florida Health — Gainesville
• Northwestern University - Feinberg School of Medicine — Chicago
• University of Kentucky — Lexington
• University of Michigan Medical Center — Ann Arbor
• Creighton University — Omaha
• Duke University — Durham
• Novant Health New Hanover Regional Medical Center — Wilmington
• … и ещё 4 центра

Идентификаторы

NCT: NCT07277946 · PF00006-CLPR-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗