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NCT06259409 · ClinicalTrials.gov registry record · Phase 1
Regenn® Therapy System Safety Study
A Phase 1 study of Surgical Wound, sponsored by Progenerative Medical.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06259409 is a Phase 1 study of Surgical Wound that is actively recruiting participants, run by Progenerative Medical. The registered enrollment target is 30 participants, below the 94-participant average among 17 other Surgical Wound trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06259409, a Phase 1 study of Surgical Wound, is actively recruiting participants, sponsored by Progenerative Medical.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DEVICE Regenn® Negative Pressure Therapy System
- DEVICE Prevena™ Incision Management System
Study Locations (1)
Kansas
- The University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-10-09 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06259409
The ClinicalTrials.gov registry entry for NCT06259409 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 94-participant average among 17 other Surgical Wound trials with a reported enrollment target (68% lower). The listed sponsor is Progenerative Medical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Surgical Wound appearing as the primary indexed condition, and to 2 interventions - of which Regenn® Negative Pressure Therapy System is the first listed.
NCT06259409 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
Frequently Asked Questions
What is clinical trial NCT06259409 about?
NCT06259409 is a clinical study titled "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...
What is the current status of trial NCT06259409?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-10-09. Estimated completion is 2026-06.
What conditions does trial NCT06259409 study?
This clinical trial studies the following conditions: Surgical Wound.
What interventions are being tested in trial NCT06259409?
The interventions under investigation include: Regenn® Negative Pressure Therapy System (DEVICE), Prevena™ Incision Management System (DEVICE).
Who is sponsoring clinical trial NCT06259409?
This trial is sponsored by Progenerative Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06259409 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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