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Regenn® Therapy System Safety Study

NCT06259409 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-15

No results posted yet for this study

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

Interventions

DEVICE

Regenn® Negative Pressure Therapy System

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

DEVICE

Prevena™ Incision Management System

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

Sponsors & Collaborators

  • Progenerative Medical, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-09
Primary Completion
2026-03-31
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06259409 on ClinicalTrials.gov