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

Study acronym: UNITE
StatusRecruiting
PhaseNot applicable
SponsorTissium
Started
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Record History

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  1. Interventions: ECLIPSIUM® System (Device), Resorbable tacks (AbsorbaTack/SorbaFix) (Device) to ECLIPSIUM® System (Device), Resorbable tacks (AbsorbaTack/SorbaFix) (Device)
    • Eligibility criteria expanded, about 29 words
    • Site details revised at 5 of 12 sites
  2. Trial sites expanded: 1 → 12 locationsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2025 to May 14, 2026
    • Study sites: 0 to 1
    • Primary and study completion dates: Jul 2026 to Dec 2026
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Tissium
3 trials monitored
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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.
Trial Details
NCT Number NCT07277946
Lead Sponsor Tissium
Conditions
(from sponsor)		 Hernia
Related terms Hernia
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov