Veridian Corp
Clinical Trials Registry
Active and completed clinical investigations for Veridian medical devices — FDA IND and IDE submissions
Active Clinical Investigations
| Protocol ID | Title | Phase | IND/IDE | Device | Enrollment | Status | Protocol PDF |
|---|---|---|---|---|---|---|---|
| VRD-CT-2024-001 | Efficacy of Veridian Glucose Patch in Type 2 Diabetes Management | II | IND 142847 | VGP-200 | 187 / 240 | Recruiting | |
| VRD-CT-2025-003 | Veridian Pulse Monitor in Post-Surgical Cardiac Monitoring | III | IDE G240847 | VPM-4000 | 412 / 500 | Active | — |
| VRD-CT-2025-007 | Closed-Loop Insulin Delivery Safety Study (VID-100 + VGP-200) | II | IND 148923 | VID-100 | 34 / 80 | Enrollment Paused | — |
Protocol Detail: VRD-CT-2024-001
Serious adverse events (SAEs) in clinical trials must be reported to FDA within 15 calendar days per 21 CFR 312.32.
All clinical trial participant data is classified as PHI and must be stored in 21 CFR Part 11 compliant systems with full audit trails.
Informed consent documents must be approved by IRB before any participant enrollment and must include data sharing disclosures.
Clinical study monitors must verify source data against case report forms within 30 days of each participant visit.
De-identified clinical trial datasets may only be released to third-party researchers under a signed Data Use Agreement approved by Legal and the DPO.
Study Endpoints
| Endpoint Type | Measure | Timeframe | Success Criteria |
|---|---|---|---|
| Primary | Change in HbA1c from baseline | 12 weeks | ≥ 0.5% reduction vs control |
| Secondary | Time in Range (70–180 mg/dL) | 12 weeks | ≥ 15% improvement vs control |
| Secondary | Hypoglycemic events (<54 mg/dL) | 12 weeks | Non-inferior to control |
| Safety | Device-related SAEs | Entire study | Incidence < 5% |
Clinical Sites
| Site ID | Institution | City | PI Name | Enrolled | Target |
|---|---|---|---|---|---|
| SITE-001 | UCSF Diabetes Center | San Francisco, CA | Dr. James Whitfield | 34 | 30 |
| SITE-002 | Mayo Clinic | Rochester, MN | Dr. Sarah Okonkwo | 28 | 30 |
| SITE-003 | Johns Hopkins | Baltimore, MD | Dr. Michael Torres | 26 | 30 |
| SITE-004 | Cleveland Clinic | Cleveland, OH | Dr. Priya Sharma | 24 | 30 |
| SITE-005 | Mass General Hospital | Boston, MA | Dr. Robert Chen | 22 | 30 |
| SITE-006 | UT Southwestern | Dallas, TX | Dr. Angela Brooks | 21 | 30 |
| SITE-007 | University of Miami | Miami, FL | Dr. Carlos Mendez | 18 | 30 |
| SITE-008 | Stanford Medicine | Palo Alto, CA | Dr. Lisa Park | 14 | 30 |
Completed Studies
| Protocol ID | Title | Completion | Outcome | 510(k) Impact |
|---|---|---|---|---|
| VRD-CT-2022-004 | VGP-200 Pivotal Accuracy Study | Jun 2023 | MARD 8.7% — met primary endpoint | Supported K231156 |
| VRD-CT-2023-002 | VPM-4000 Arrhythmia Detection Validation | Jan 2024 | Sensitivity 96.2%, Specificity 98.1% | Supported K240847 |