Regenn® Therapy System Safety Study

Phase 1RecruitingNCT06259409

Progenerative Medical, Inc30 enrolled

Overview

The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical wounds of patients undergoing lumbar spinal fusion surgeries. The main questions the study aims to answer are: * The device-related serious adverse event rate. * Patient post-operative pain as assessed using a validated pain measurement scoring system. * The number and type of adverse events. * The rate of delayed seroma formation. Participants will * Be screened for their suitability to participate in the investigational study using questions about their health, medical history, and current medications. * Undergo a physical exam, an assessment of patient vital signs and routine blood analyses. * Complete an Informed Consent Form if selected to participate in the investigational study. * Be randomly assigned to the different study arms. * Not change the operation of their respective device or to disturb components of their device. * Notify their surgeon or designated healthcare provider should they have any questions or encounter any issues with their device. * Attend two post-operative visits at approximately one month and three months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Surgical Wound

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Device-related Serious Adverse Event Rate

The device-related serious adverse event rate associated with the use of the investigational device and the comparator device. Wound complications requiring surgical intervention, such as wound dehiscence, will be the primary indicator of blood supply at the wound site, damage to the surrounding tissue, and progression of wound healing.

Time frame: Post-operative follow ups at 2-8 weeks and 3-6 months.

Secondary Outcomes

Post-operative Pain Profile

Post-operative pain will be assessed using the Numerical Rating Scale (NRS), a validated pain measurement scoring system with a pain rating scale of 0 - 10, where zero means "No pain" and 10 means "The worst pain imaginable"

Time frame: Post-operative up to the 3-6 month follow up visit.

Adverse Events Related to the Investigational Device

The number and type of adverse events associated with the use of the investigational device. Assessment will include wound complications not requiring surgical intervention, device complications, medical complications and infections complications.

Time frame: Post-operative follow ups at approximately one month and three months.