Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02408458
Other study ID # 2015001
Secondary ID
Status Withdrawn
Phase N/A
First received March 26, 2015
Last updated October 2, 2017
Start date June 2015
Est. completion date April 2016

Study information

Verified date October 2017
Source Miromatrix Medical Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.


Description:

Miromatrix Medical Inc. has developed a new biologic mesh, called MIROMESH®. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. Miromatrix Biologic Mesh is a non cross-linked, acellular surgical mesh that is derived from the highly vascularized porcine liver. This study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting MIROMESH for ventral hernia repair.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- between 18 and 80 years old on the day of study enrollment

- ventral or incisional hernia greater than 9 cm2 for which the physician anticipates ability to achieve midline fascia closure following a retro-rectus repair/component separation

- hernia classified as CDC class 1 or 2 preoperatively

- able and willing to sign the consent form and comply with all study visits and procedures

- commit to non-smoking for at least 4 weeks prior to procedure

Exclusion Criteria:

- sensitivity to porcine material

- scheduled for a concomitant procedure of a wound classified as other than clean

- immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the Investigator

- BMI =40

- A1C level =10.0

- participating in another clinical study

- cirrhosis, and/or ascites

- diagnosed with a collagen vascular disorder

- American Society of Anesthesiology (ASA) Class 4 or 5

- allergic to tetracycline or kanacmycin

- life expectancy of less than 2 years at the time of enrollment

- any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MIROMESH®


Locations

Country Name City State
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States University of Kentucky Lexington Kentucky
United States University of Wisconsin Madison Wisconsin
United States Sarasota Memorial Hospital Sarasota Florida

Sponsors (1)

Lead Sponsor Collaborator
Miromatrix Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hernia recurrence requiring surgical intervention 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT06016426 - Mass Closure vs Layer by Layer Closure N/A
Recruiting NCT05572021 - A Comparison of the Outcomes in Fortiva and Strattice Mesh N/A
Completed NCT02263599 - Conservative Treatment For Ventral Hernia
Completed NCT02263625 - Regional Differences In Indication for Ventral Hernia Repair
Completed NCT02292264 - Risk Factors and Complications of Ventral Hernia Repair
Completed NCT01961687 - A Prospective, Multi-Center Study of Phasixâ„¢ Mesh for Ventral or Incisional Hernia Repair. N/A
Completed NCT01325246 - Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair N/A
Completed NCT03283982 - Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM N/A
Not yet recruiting NCT05526209 - Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia
Completed NCT04438369 - Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair. N/A
Recruiting NCT04173884 - Video-based Collaborative Learning to Improve Ventral Hernia Repair N/A
Recruiting NCT02703662 - Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction Phase 2/Phase 3
Completed NCT03938688 - Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation N/A
Completed NCT01719718 - The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair N/A
Completed NCT03342040 - Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair N/A
Completed NCT04150796 - Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernias N/A
Recruiting NCT03222102 - Ventral Hernia Prevention After Liver Transplantation N/A
Completed NCT05610267 - Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Terminated NCT01794338 - The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients N/A
Completed NCT01886963 - A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair N/A