Regenn® Therapy System Safety Study
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
| Condition(s) | Surgical Wound |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 si |
| 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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Progenerative Medical, Inc |
| Locations | Kansas City, Kansas, United States |
| Start date | 2024-10-09 |
| NCT ID | NCT06259409 |
| Official listing | https://clinicaltrials.gov/study/NCT06259409 |