Trials / Enrolling By Invitation
Enrolling By InvitationNCT06384183
Kerecis Real-World Fish Skin Graft Registry
Kerecis Real-World Fish Skin Graft Registry - "ISACOD"
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (estimated)
- Sponsor
- Kerecis Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices
Detailed description
This observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. These clinical data will be used at Kerecis for many purposes, which include, but are not limited to, device safety and performance evaluation as part of routine patient care and post-market clinical follow-up data commitments to regulatory authorities around the world.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Kerecis Fish Skin Graft | Patients already treated with a Kerecis device |
Timeline
- Start date
- 2024-08-07
- Primary completion
- 2026-06-01
- Completion
- 2027-06-01
- First posted
- 2024-04-25
- Last updated
- 2024-12-30
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06384183. Inclusion in this directory is not an endorsement.