Regenn® Therapy System Safety Study

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Surgical Wound

Clinical Trial Details

NCT number	NCT06259409
Study type	Interventional
Source	Progenerative Medical, Inc
Contact	Neal K Vail, PhD
Phone	(844) 977-6436
Email	clinical@progenerative.com
Status	Not yet recruiting
Phase	Phase 1
Start date	May 2024
Completion date	May 2025

View Details

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