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Surgical WoundPhase 1NCT06259409

Regenn® Therapy System Safety Study

A Phase 1 study testing Regenn® Negative Pressure Therapy System and Prevena™ Incision Management System in people with Surgical Wound, run by Progenerative Medical, Inc at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Surgical Wound
What is being tested?
Regenn® Negative Pressure Therapy System and Prevena™ Incision Management System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
9 Oct 2024to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: A Randomized Clinical Study Evaluating the Safety of Regenn® Negative Pressure Therapy System in Orthopaedic Surgical Wound Management

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.
Read more

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.
Conditions
Surgical Wound
Being tested
Regenn® Negative Pressure Therapy System, Prevena™ Incision Management System
Medical subject headings
Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regenn® Negative Pressure Therapy SystemDevice

    Also called NPWT, Negative Pressure Wound Therapy

    Controlled application of negative pressure (i.e., reduced atmospheric pressure or mild vacuum) to manage the wound environment.

  • Prevena™ Incision Management SystemDevice

    Also called NPWT, Negative Pressure Wound Therapy

    Controlled application of negative pressure (i.e., reduced atmospheric pressure or mild vacuum) to manage the wound environment.

Study groups in NCT06259409
Study groupRoleWhat they receive
Treatment ArmExperimentalThis group will receive the study device, Regenn® Negative Pressure Therapy System, a form of Negative Pressure Wound Therapy (NPWT). Regenn® Therapy manages the surgical wound by the application of reduced pressure therapy (i.e., mild vacuum). Reduced pressure therapy is controlled by a hand-sized, battery-operated pump and is delivered by an attached small, dressing that the surgeon places in the surgical wound at the end of the surgery. Reduced pressure therapy is applied while the patient recovers from surgery.
Receives: Device: Regenn® Negative Pressure Therapy System
Control ArmActive comparatorThis group will receive the control device, also a form of Negative Pressure Wound Therapy (NPWT), which manages the surgical wound by the application of reduced pressure therapy (i.e., mild vacuum). Reduced pressure therapy is controlled by a hand-sized, battery-operated pump and is delivered by a small tube connected to a wound dressing placed over the closed surgical wound at the end of the surgery. Reduced pressure therapy is applied while the patient recovers from surgery.
Receives: Device: Prevena™ Incision Management System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (2)

  1. 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"

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start9 Oct 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, controlled investigational study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06259409
Sponsor's protocol ID
Doc-0353
Status last verified
Aug 2026
First submitted
26 Jan 2024
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Regenn® Negative Pressure Therapy System and Prevena™ Incision Management System in people with Surgical Wound, run by Progenerative Medical, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device-related Serious Adverse Event Rate (time frame: Post-operative follow ups at 2-8 weeks and 3-6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06259409.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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