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