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Safety Study of Regenn® Therapy System for Surgical Wounds

This study is looking at the safety of the Regenn® Negative Pressure Therapy System (Regenn® Therapy) for people who have had lumbar spinal fusion surgery. This system uses a mild vacuum to help manage surgical wounds. Researchers want to see how often serious problems related to the device occur, how much pain patients have after surgery, and the overall number and types of side effects. You might be able to join if you are between 18 and 80 years old and have certain back conditions like spondylolisthesis or degenerative disc disease. The study is currently unclear on its status and plans to enroll 30 participants.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is designed to evaluate the safety of the Regenn® Negative Pressure Therapy System.
What's involved
You will be screened with questions about your health, medical history, and current medications. The record does not specify further procedures or visit schedules.
Compensation
Not stated in the trial record.
Follow-up
You will be followed up post-operatively at 2-8 weeks and 3-6 months to assess for device-related serious adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06259409

Regenn® Therapy System Safety Study

Active, Not Recruiting
PHASE1Ages 18–80InterventionalTreatment
Progenerative Medical, Inc
~30 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Regenn® Negative Pressure Therapy SystemPrevena™ Incision Management System

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device-related Serious Adverse Event Rate
Measured over Post-operative follow ups at 2-8 weeks and 3-6 months.

Conditions

Surgical Wound

Explore related trials

Surgical wound

Where it's being run

1 sites across 1 states
Kansas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Device-related Serious Adverse Event RatePost-operative follow ups at 2-8 weeks and 3-6 months.

    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.