What is the ECLIPSIUM device studying for hernia repair?

The ECLIPSIUM device is being studied to see how well it secures mesh during laparoscopic ventral hernia repair compared to resorbable tacks. Researchers want to understand if it reduces the risk of hernia recurrence and improves safety. This study is sponsored by Tissium and focuses on evaluating this new fixation method.

Who may be eligible for this hernia clinical trial?

Adults aged 22 years or older with a single midline primary ventral, umbilical, or incisional hernia scheduled for laparoscopic IPOM repair may be eligible. Participants must be able to consent and follow study instructions. People who smoke more than one cigarette per day or have a BMI over 40 are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this hernia clinical trial?

Study-related care, including the device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase Not Applicable

Age: 22Years +

All Genders

ID07277946

Evaluating Safety and Effectiveness of the ECLIPSIUM Device Compared to Resorbable Tacks for Laparoscopic Ventral Hernia Repair

Led by Tissium · Updated on 2026-06-09

240

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and performance of the ECLIPSIUM device in securing mesh during laparoscopic ventral hernia repair. This study compares the ECLIPSIUM System, a bioresorbable polymer-based fixation device, with bioresorbable tacks, to see if it can reduce the risk of hernia recurrence. The trial is designed as a prospective, multi-center, randomized, active control, single-blind non-inferiority study to assess these devices in patients undergoing this surgical procedure. The ECLIPSIUM System works by applying a biodegradable polymer coating to the mesh and activating it in place with a special light to secure the mesh to the abdominal wall. The comparator group uses resorbable tacks, which are surgical fasteners that dissolve over time as the tissue grows into the mesh. Both devices are used during laparoscopic intraperitoneal onlay mesh ventral hernia repair. Participants receive one of these fixation methods during their surgery. Participants will be evaluated for hernia recurrence at 6 and 12 months after surgery as the primary outcome. The study will also monitor complications for up to 12 months. Throughout the trial, participants will follow study instructions, attend scheduled visits, and complete assessments. The total participation duration extends to at least 12 months post-surgery to measure safety and effectiveness outcomes fully.

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

Age: 22Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient is 22 years old or older.
Patient can provide signed informed consent.
Patient has a single midline primary ventral, umbilical, or incisional hernia.
Hernia size is between 1 and 5 cm in diameter (confirmed during surgery).
Patient is scheduled for laparoscopic intraperitoneal onlay mesh (IPOM) hernia repair.
Hernia is repairable with a single polyester or polypropylene composite mesh with biodegradable coating and at least 5 cm overlap on all sides (confirmed during surgery).
Female patients must have a negative urine pregnancy test within 3 days before surgery and use effective contraception, or have reached menopause, or have had hysterectomy, bilateral oophorectomy, or tubal ligation.
Patient can follow study instructions and complete all procedures and visits.

You will not qualify if you...

Known or suspected allergy to the polymers in the device, mesh, or surgical products.
Taking systemic photosensitivity medications at consent.
Body mass index (BMI) over 40.
Current smoker smoking more than one cigarette per day.
Recurrent hernia or previous mesh repair for the same hernia type.
Life expectancy less than one year as judged by the investigator.
Unable or unwilling to follow postoperative instructions.
Taking systemic immunosuppressive medications, steroids, or chemotherapy at consent.
Pregnant, breastfeeding, or planning pregnancy during the study.
Diagnosed with Type 1 Diabetes Mellitus.
Uncontrolled Type 2 Diabetes Mellitus with HbA1C ≥ 7.0 within 3 months before enrollment.
Participating in another investigational drug or device study interfering with this trial.
More than one hernia defect.
Areas of weakness near the hernia or adjacent tissues (confirmed during surgery).
Complex hernia not suitable for laparoscopic repair.
Scheduled for additional surgery within 6 weeks after or had surgery within 90 days before the procedure.
Severe chronic obstructive pulmonary disease.
Ongoing infection such as elevated temperature or white blood count.
Investigator considers patient unsuitable for the study.

Research Team

Nikia Trinward

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