Kansas City, KSNCT06259409Now EnrollingIRB Ready

Surgical Wound Clinical Trial in Kansas City, KS

Access cutting-edge surgical wound treatment through this clinical trial at a research site in Kansas City. Study-provided care at no cost to qualified participants.

Sponsored by Progenerative Medical, Inc

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Expert Care in Kansas City

Access surgical wound specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related surgical wound treatment provided free

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Check if you qualify for this surgical wound clinical trial in Kansas City, KS

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Kansas City

    Convenient for KS residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Kansas City site if eligible
  4. 4Begin participation

About This Surgical Wound Study in Kansas City

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.

Sponsor: Progenerative Medical, Inc

Who Can Participate

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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Kansas City?

Yes, this clinical trial (NCT06259409) has an active research site in Kansas City, KS that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Surgical Wound Treatment Options in Kansas City, KS

If you're searching for surgical wound treatment options in Kansas City, KS, this clinical trial (NCT06259409) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Kansas City research site is actively enrolling participants for this clinical trial. You'll receive care from experienced surgical wound specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all surgical wound clinical trials near you to find additional studies recruiting in your area.

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