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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.
A prospective, multi-center, randomized, active control, single-blind non- inferiority study designed to evaluate the safety and effectiveness of the ECLIPSIUM® System versus bioresorbable tacks in mesh fixation in patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECLIPSIUM System | Experimental | 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. |
|
| Resorbable tacks (AbsorbaTack/SorbaFix) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hernia Recurrence at 6 months | Rate of hernia recurrence of the ECLIPSIUM System compared to resorbable tacks at 6 months post-surgery. | 6 months |
| Cumulative Incidence of Complications | Safety of the ECLIPSIUM System will be assessed by collecting and analyzing the cumulative incidence of complications (CIC) related to the ECLIPSIUM System including the following complications:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hernia Recurrence at 12 months | The secondary efficacy outcome of this study is to demonstrate the rate of hernia recurrence of the ECLIPSIUM System is non-inferior compared to resorbable tacks at 12 months post-surgery. | 12 months |
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Inclusion Criteria:
Patient is 22 years old or older.
Patient is willing and able to provide a signed Patient Informed Consent Form.
Patient has a single midline primary ventral, umbilical, or incisional hernia;
a.Hernia Size is 1 -5 cm in diameter (to be confirmed intraoperatively).
Patient is scheduled for a laparoscopic IPOM hernia repair.
Hernia can be successfully repaired with a single polyester or polypropylene composite mesh with biodegradable coating with at least a 5 cm overlap of the mesh on all sides of the defect (to be confirmed intraoperatively).
Female patients must:
Have a negative urine pregnancy test within 3 days before surgery and agree to consistently use an effective method of contraception through completion of study participation.
OR
Have reached menopause (no menses for 1 year). OR
Have undergone hysterectomy, bilateral oophorectomy, or tubal ligation.
Patient is willing and able to follow the study instructions including completion of study procedures, assessments, and visits.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikia Trinward | Contact | 1-857-408-0709 | ntrinward@tissium.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Rosen | Northwestern University | Principal Investigator |
| William Hope | New Hanover Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Loma Linda | Not yet recruiting | Loma Linda | California | 92357 | United States |
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1:1 randomization, single-blinded
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|
| 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. |
|
| University of Florida Health | Not yet recruiting | Gainesville | Florida | 32610 | United States |
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| Northwestern University - Feinberg School of Medicine | Recruiting | Chicago | Illinois | 60611 | United States |
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| University of Kentucky | Not yet recruiting | Lexington | Kentucky | 40536 | United States |
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| University of Michigan Medical Center | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Creighton University | Not yet recruiting | Omaha | Nebraska | 68178 | United States |
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| Duke University | Not yet recruiting | Durham | North Carolina | 27704 | United States |
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| Novant Health New Hanover Regional Medical Center | Recruiting | Wilmington | North Carolina | 28403 | United States |
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| Cleveland Clinic Foundation | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
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| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| University of Tennessee Medical Center | Recruiting | Knoxville | Tennessee | 37920 | United States |
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| Tidewater Physicians Multi Specialty Group Hernia Center | Recruiting | Newport News | Virginia | 23606 | United States |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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