Mesh fixation for ventral hernia repair using ECLIPSIUM device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center, randomized study that compares the ECLIPSIUM fixation system to bioresorbable tacks for mesh fixation during laparoscopic IPOM ventral hernia repair. It uses an active control and a single-blind, non-inferiority design to evaluate safety and effectiveness. Participants are adults with a single midline ventral, umbilical, or incisional hernia suitable for mesh repair. The study will assess whether ECLIPSIUM provides non-inferior or improved performance in preventing recurrence and in handling during surgery. Lead sponsor is Tissium, with sites in California, Florida, and Illinois.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

   a.Hernia Size is 1 -5 cm in diameter (to be confirmed intraoperatively).
4. Patient is scheduled for a laparoscopic IPOM hernia repair.
5. 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).
6. Female patients must:

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

Exclusion Criteria:

1. 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).
2. Patient is taking systemic photosensitivity pharmaceutical products at time of informed consent.
3. Patient has a BMI \> 40.
4. Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day.
5. Patient's hernia is recurrent and/or the patient has a previous midline primary ventral, umbilical, or incisional hernia repair with mesh implantation.
6. Patient has a life expectancy less than 1 year, in the opinion of the Investigator.
7. Patient is unwilling or unable to follow postoperative instructions.
8. Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent.
9. Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding.
10. Patient has a diagnosis of Type 1 Diabetes Mellitus.
11. Patient has uncontrolled Type 2 Diabetes Mellitus (HbA1C ≥ 7.0 within 3 months preceding study enrolment).
12. 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).
13. 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).
14. 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).
15. Patient with a complex hernia, likely not eligible for laparoscopic repair, as determined by the Investigator (ex. small bowel resection; to be confirmed intraoperatively).
16. 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.
17. Patient has severe chronic obstructive pulmonary disease.
18. Patient has an ongoing infection (e.g. elevated temperature, elevated white blood count).
19. In the opinion of the Investigator, the patient is not a suitable candidate for the clinical investigation.

Where it's running

• Northwestern University - Feinberg School of Medicine
  Chicago, Illinois, United States Recruiting
• University of Kentucky
  Lexington, Kentucky, United States Recruiting
• University of Michigan Medical Center
  Ann Arbor, Michigan, United States Recruiting
• Creighton University
  Omaha, Nebraska, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting
• Novant Health New Hanover Regional Medical Center
  Wilmington, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Michael Rosen — Northwestern University
• Study coordinator: Nikia Trinward
• Email: ntrinward@tissium.com
• Phone: 1-857-408-0709

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.