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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.