Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Incidence of related serious adverse events
Study Overview
Brief Summary
This registry will assess clinical outcomes following the use of Cryopreserved Amniotic Membrane (CAM) for the treatment of orthopedic and various other conditions. This registry will collect outcomes data via a registry of up to 100 patients who have received treatment with CAM in the post-market setting. Patients will be enrolled from up to five healthcare centers.
Detailed Description
The objective of this registry is to collect outcomes data via a registry on the uses of CAM in the post-market setting, including:
- Adverse events related to the treatment, or the product, will be collected for up to 12 weeks following the treatment.
- Improvements in appropriate effectiveness markers for CAM use in patients treated for various conditions.
- Improvements in overall quality of life resulting from CAM treatment in patients.
An additional objective is to determine standard of care follow-up for the target treatments, including effectiveness metrics used and typical follow-up schedule.
This registry is intended to collect clinical data from patients for analysis purposes only and will not be used to treat patients. The plan does not allow for any deviation from standard of care practice. Therefore, there is no added risk to patients from participating in the registry.
The sponsor will use an electronic data capture (EDC) system for capturing all the data from the sites. The system will be built and validated prior to initiation of the sites. Each participating physician or appropriately trained designee shall enter data into the EDC system, providing all applicable data and documentation to the sponsor. Data will be reviewed for missing data, data consistency, and reasonableness of responses. Discrepancies will be resolved through a formal query process within the EDC system, and may involve direct contact with hospital staff.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A patient is suitable for inclusion in this registry if the patient has been treated with CAM for any indication as per the standard of care practice.
Exclusion Criteria
- •Patients are excluded from registry enrollment if they are under the age of 22 years.
Outcomes
Primary Outcomes
Incidence of related serious adverse events
Time Frame: 12 weeks
Number of related serious adverse events occurred
Secondary Outcomes
- Visual Analog Scale(12 weeks)
- Change in wound size(12 weeks)
- Change in analgesic use(12 weeks)
- Time to complete wound closure(12 weeks)