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

Conditions

• Hernia

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ECLIPSIUM® System — DEVICE
  The ECLIPSIUM® System functions by applying a biodegradable, implantable polymer coating to the prosthetic material under guidance of a template to ensure appropriate application, followed by in situ photo-activation using the TISSIUM curing light to secure the mesh to the abdominal wall.
• Resorbable tacks (AbsorbaTack/SorbaFix) — DEVICE
  Resorbable tacks are surgical fasteners used to secure a hernia mesh in place. Resorbable tacks are designed to be absorbed by the body over time, gradually losing strength as the tissue ingrowth into the mesh occurs and takes over the support function.

Study Details

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.

Key Dates

Start date

May 14, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ECLIPSIUM System
  The ECLIPSIUM System is intended for non-penetrating connection and fastening of prosthetic materials, such as composite meshes, to internal soft tissue during minimally invasive hernia repair procedures by coating the prosthetic material with the biodegradable implantable polymer and photoactivating it in situ with a TISSIUM curing light.
• Active Comparator: Resorbable tacks (AbsorbaTack/SorbaFix)
  Resorbable tacks are surgical fasteners used to secure a hernia mesh in place. Resorbable tacks are designed to be absorbed by the body over time, gradually losing strength as the tissue ingrowth into the mesh occurs and takes over the support function.

Primary Outcome Measure

Hernia Recurrence at 6 months [ Time Frame: 6 months ]

Central Contacts

• Nikia Trinward
  1-857-408-0709
  [email protected]

Locations (12)

Find similar trials in Loma Linda, CA

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