AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
Recruiting
N/A
Interventional Study
Hernia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 240 (estimated)
- Sponsor
- Tissium · Industry
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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 po…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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…
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