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

ConditionHernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorTissium

About this trial

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.

Eligibility criteria

Qualifiers

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;

Patient is scheduled for a laparoscopic IPOM hernia repair.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ECLIPSIUM® System
  • Resorbable tacks (AbsorbaTack/SorbaFix)

Treatment groups

240 Participants
are divided into 2 treatment groups

Sponsors and collaborators