Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Surgical Wound, sponsored by Progenerative Medical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT06259409 shows while recruiting
NCT06259409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 94-participant average among 17 other Surgical Wound trials with a reported enrollment target (68% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Surgical Wound
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06259409's enrollment target sits among peer trials
30 15th of 17 higher than 2 of 17 other Surgical Wound trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgical Wound trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Zinc Oxide Versus Petrolatum Following Skin Surgery
RECRUITING · Early Phase 1
-
Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction
RECRUITING · Phase 2
-
Early Versus Delayed Bathing of Orthopaedic Surgical Wounds
RECRUITING · NA
-
A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
RECRUITING
-
fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
RECRUITING
-
Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI