RecruitingHernia

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

Eligible age

22+ yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

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.

Sponsor: Tissium

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.