GORE® SYNECOR Biomaterial for Hernia
(SYN 20-01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of the GORE® SYNECOR Biomaterial for individuals with ventral or incisional hernias. It will assess how well this special mesh performs in hernia repair surgeries. Researchers will follow participants for up to 60 months to monitor long-term success. The trial includes two groups, each using a different mesh technique. It is best suited for individuals with a new, clean hernia that can be repaired with the mesh. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the validation of a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for GORE® SYNECOR Biomaterial?
Research has shown that the GORE® SYNECOR Biomaterial, used for hernia repair, is generally well-accepted by patients. For the SYNECOR Preperitoneal Biomaterial, studies have found it effectively repairs hernias with few complications, and reports indicate minimal negative side effects for patients.
Similarly, the SYNECOR Intraperitoneal Biomaterial has demonstrated good results. One study found a very low hernia recurrence rate of 0.9% over an average of 32 months, with no cases of fluid buildup reported after 12 months.
Overall, current evidence suggests both treatments are safe. Most patients experience successful outcomes with few complications.12345Why are researchers excited about this trial?
Researchers are excited about GORE® SYNECOR Biomaterials because they offer innovative solutions for hernia repair. Unlike traditional mesh repairs, which often involve single-layer materials, SYNECOR uses a multi-layered composite that combines strength with flexibility. This design aims to improve integration with the body's tissues and reduce complications like infections or mesh rejection. Additionally, the SYNECOR PRE and SYNECOR IP devices are tailored for preperitoneal and intraperitoneal applications, potentially offering more precise options for different types of hernias. These advancements could lead to better patient outcomes and a quicker return to normal activities.
What evidence suggests that GORE® SYNECOR Biomaterial is effective for hernia mesh repair?
This trial will compare two applications of GORE® SYNECOR Biomaterial for hernia repair. Research has shown that the GORE SYNECOR Preperitoneal Biomaterial uses a strong mesh that helps prevent hernias from recurring. Patients who underwent surgery with this mesh experienced low rates of hernia recurrence, indicating good long-term results.
The GORE SYNECOR Intraperitoneal Biomaterial, another treatment arm in this trial, features a sturdy design aimed at lasting repairs. This hybrid mesh is strong and reduces the risk of infection. Studies have reported successful outcomes in most patients, with a low chance of hernia recurrence, supporting its effectiveness in complex cases.23678Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Hernia mesh repair with GORE® SYNECOR Biomaterial
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GORE® SYNECOR Biomaterial
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial
Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial
Find a Clinic Near You
Who Is Running the Clinical Trial?
W.L.Gore & Associates
Lead Sponsor
Bret Snyder
W.L.Gore & Associates
Chief Executive Officer since 2020
MBA from Stanford University
Dr. John Doe
W.L.Gore & Associates
Chief Medical Officer since 2023
MD from Harvard Medical School
Citations
GORE® SYNECOR Intraperitoneal Biomaterial
GORE® SYNECOR Intraperitoneal Biomaterial provides a robust tri-layer solution for lasting repairs in complex surgical cases.
Evaluation of Long-term Performance of the GORE ...
In this study, inguinal hernia repair with the hybrid composite mesh was successful in most patients and the rate of recurrence was low.
Early Surgical Outcomes in the Use of Hybrid Mesh for ...
The GORE® SYNECOR Intraperitoneal (IP) Biomaterial, a hybrid mesh, aims to balance durability and infection risk. Objective: To analyze extended-term outcomes ...
4.
researchgate.net
researchgate.net/publication/369558655_Evaluation_of_Long-term_Performance_of_the_GORE_SYNECOR_Intraperitoneal_Biomaterial_in_the_Treatment_of_Inguinal_Hernias(PDF) Evaluation of Long-term Performance of the GORE ...
Conclusions: In this study, inguinal hernia repair with the hybrid composite mesh was successful in most patients and the rate of recurrence was ...
Assessment of GORE® SYNECOR Biomaterial in Focused ...
Patients with ventral / incisional hernia amenable to hernia mesh repair will be enrolled into two cohorts (US and EU cohort) and followed-up over the period of ...
SYNECOR Intraperitoneal - Clinical Data Summary
Quality outcomes · Hernia recurrence: 0.9% clinically confirmed hernia recurrence (4/459 patients, mean 32 months) · Seroma: 0% (12 months) · Surgical site ...
GORE ® SYNECOR Biomaterial
Early clinical and patient-reported outcomes of a new hybrid mesh for incisional hernia repair. Journal of Surgical Research 2021;265:49-59. Olson TB.
Evaluation of long-term performance of an intraperitoneal ...
One-year device safety and clinical outcomes of ventral hernia repair with the GORE® SYNECOR Intraperitoneal Biomaterial, a hybrid composite ...
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