Regenn® Therapy System Safety Study

Launched by PROGENERATIVE MEDICAL, INC · Feb 12, 2024

Keywords

ClinConnect Summary

The Regenn® Therapy System Safety Study is a clinical trial that aims to test the safety of a new device called the Regenn® Negative Pressure Therapy System. This device is designed to help with healing after surgery, specifically for patients undergoing lumbar spinal fusion surgery, which is a procedure to stabilize the lower back. The study will look at how safe the device is by monitoring any serious side effects, measuring post-operative pain, and checking for complications like fluid buildup in the surgical area.

To participate in this study, individuals must be between 18 and 80 years old and have specific back conditions, such as certain types of spinal instability or degenerative disc disease. Potential participants will need to go through a health screening process, including a physical exam and medical history review. If selected, they will be randomly assigned to different groups and will be asked to attend two follow-up visits after their surgery. It's important for participants to follow the study guidelines and keep their healthcare team informed about any questions or issues they might have during the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (must meet ALL):
• • Subject has provided written informed consent on a form reviewed and approved by the Institutional Review Board for the clinical site.
• • The subject is 18 - 80 years old.
• * The subject has Spondylolisthesis of Meyerding Grade II or less, or has Degenerative Disc Disease (DDD) accompanied by back pain with or without leg pain at a level between L1 and S1 confirmed by history and radiographic assessment. DDD is determined to be present if one or more of the following are noted:
• • Instability (defined as angulation ≥ 5 degrees and/or translation ≥ 3mm on flexion/extension radiographs;
• • Osteophyte formation of facet joints or vertebral endplates;
• • Decreased disc height, on average by \>2mm, but dependent upon the spinal level;
• • Scarring / thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;
• • Herniated nucleus pulposus;
• • Facet joint degeneration / changes; and/or
• • Vacuum phenomenon.
• • Female subjects of childbearing potential must not be pregnant or nursing and must agree to use of contraception for the study duration. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test and birth control.
• • The subject is willing and able to comply with the protocol mandated follow-up visits and testing regimen.
• Exclusion Criteria (candidates meeting ANY of the following at the time of the study procedure are NOT eligible):
• • Subject is unable or unwilling to provide informed consent or is unable to conform to the study protocol follow-up procedures and visits.
• • Subject has a contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, bone allograft, or blood transfusion that is not amenable to pretreatment with steroids or/and antihistamines.
• • Subject has a history of bleeding diatheses or coagulopathy.
• • Subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or any autoimmune diseases.
• • Subject is receiving dialysis or immunosuppressive therapy.
• • Subject suffered a hemorrhagic stroke \< 6 months prior to the study procedure.
• • Subject is undergoing spinal surgery for vertebral fracture, trauma, or scoliosis.
• • Subject has any form of active malignancy.
• • Subject is an intravenous drug user and/or alcoholic.
• • Subject is diagnosed with septicemia at the time of the study procedure.
• • Subject is a smoker.
• • Subject has Type I diabetes.
• • Subject has overt, uncontrolled Type II diabetes.
• • Subject has a condition requiring postoperative medications that would be expected to interfere with fusion (e.g., steroids), or has received drugs that interfere with bone metabolism within 2 weeks of the surgery.
• • Subject is suffering from gross obesity, defined as \> 40% IBW.
• • Subject exhibits Waddell signs of Inorganic Behavior ≥ 3.
• • Subject has had a previous, anterior spinal fusion, interbody spinal fusion, or posterior spinal instrumentation at the involved level.
• • Subject has another medical condition, which may cause them to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years.
• • Subject has a systemic disease of connective tissue such as Rheumatoid Arthritis, or Ankylosing Spondylitis.
• • Subject is a prisoner.
• • Subject is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).