Regenn® Therapy System Safety Study

NCT06259409 | Recruiting Phase 1 FDA Device

• 1 other identifier: Doc-0353
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Surgical Wound

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Post-operative Pain Profile

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

• Adverse Events Related to the Investigational Device

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

Other Outcomes (1)

• Delayed Seroma Formation Rate

  Post-operative follow up at 2-8 weeks (at the surgeon's discretion) and at 3-6 months (required).

Study Arms (2)

Treatment Arm

EXPERIMENTAL

This 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.

Device: Regenn® Negative Pressure Therapy System

Control Arm

ACTIVE COMPARATOR

This 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.

Device: Prevena™ Incision Management System

Interventions

Regenn® Negative Pressure Therapy System DEVICE

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

Also known as: NPWT, Negative Pressure Wound Therapy

Treatment Arm

Prevena™ Incision Management System DEVICE

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

Also known as: NPWT, Negative Pressure Wound Therapy

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Progenerative Medical, Inc: lead

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Central Study Contacts

Neal K Vail, PhD

CONTACT

(844) 977-6436; clinical@progenerative.com

James W Poser, PhD

CONTACT

(844) 977-6436; clinical@progenerative.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled investigational study

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 14, 2024
• Study Start: October 9, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)