Actively Recruiting
AtraUmatic Laparoscopic Hernia Repair Clinical Investigation to Evaluate the Safety and Performance of the ECLIPSIUM System for Mesh Fixation
Led by Tissium · Updated on 2026-05-28
240
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair. It compares ECLIPSIUM, a bioresorbable polymer-based fixation device, to bioresorbable tacks to determine if it can reduce the risk of hernia recurrence. The study is a prospective, multi-center, randomized, single-blind trial designed to assess whether ECLIPSIUM offers clinical benefits in laparoscopic intraperitoneal onlay mesh ventral hernia repair procedures. Participants will receive one of two treatments: the ECLIPSIUM System, which applies a biodegradable polymer coating to the mesh and secures it with photoactivation using a special curing light, or resorbable tacks that fasten the mesh and are absorbed by the body over time. Each participant undergoes laparoscopic ventral hernia repair with mesh fixation using either method. The study will monitor outcomes over 12 months, including hernia recurrence and complications. During the study, participants will have assessments at 6 and 12 months to check for hernia recurrence and any complications. The trial includes follow-up visits and evaluations to monitor safety and effectiveness. Participants will be observed for the cumulative incidence of complications up to 12 months, and the primary outcome measurement is hernia recurrence at 6 months. The total duration of participation will vary depending on individual follow-up schedules.
CONDITIONS
Brief Title
AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 22 years old or older.
- Patient is willing and able to provide signed informed consent.
- Patient has a single midline primary ventral, umbilical, or incisional hernia with size 1-5 cm.
- Patient is scheduled for laparoscopic IPOM hernia repair.
- Hernia can be repaired with a single polyester or polypropylene composite mesh with biodegradable coating and at least 5 cm overlap.
- Female patients must have a negative pregnancy test before surgery and use effective contraception, or have reached menopause, or have had hysterectomy, bilateral oophorectomy, or tubal ligation.
- Patient is willing and able to follow study instructions and complete visits and assessments.
You will not qualify if you...
- Known or suspected hypersensitivity to device polymers, mesh, or surgical products.
- Taking systemic photosensitivity medications at consent.
- Body mass index over 40.
- Current smoker of more than 1 cigarette per day.
- Recurrent hernia or previous mesh hernia repair.
- Life expectancy less than 1 year.
- Unable or unwilling to follow postoperative instructions.
- Taking systemic immunosuppressants, steroids, or chemotherapy at consent.
- Pregnant, plans pregnancy, or breastfeeding.
- Diagnosis of Type 1 Diabetes Mellitus.
- Uncontrolled Type 2 Diabetes Mellitus (HbA1C ≥ 7.0 within 3 months).
- Participating in another investigational drug or device study interfering with this study.
- More than one hernia defect.
- Areas of weakness in mesh-covered tissues unrelated to hernia.
- Complex hernia not suitable for laparoscopic repair.
- Scheduled for additional surgery within 6 weeks after or had surgery within 90 days before hernia repair.
- Severe chronic obstructive pulmonary disease.
- Ongoing infection.
- Deemed unsuitable by the investigator for the study.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo laparoscopic intraperitoneal onlay mesh ventral hernia repair using either the ECLIPSIUM System or resorbable tacks to secure the mesh to the abdominal wall.
1 surgical procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and effectiveness outcomes including hernia recurrence and complications after surgery.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Tidewater Physicians Multi Specialty Group Hernia Center
Newport News, Virginia, United States, 23606
Actively Recruiting
Research Team
N
Nikia Trinward
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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