Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications
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|ClinicalTrials.gov Identifier: NCT04222166|
Recruitment Status : Completed
First Posted : January 9, 2020
Last Update Posted : August 27, 2021
|Condition or disease||Intervention/treatment|
|Orthopedic Disorder Wound||Biological: CAM|
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.
The conduct of the registry will be supervised through a process of centralized and on-site monitoring. The sponsor may remotely monitor the registry for data completeness and for adverse events. On-site monitoring will be implemented as necessary throughout the course of the registry. The physician/clinic will provide direct access to source data/documents for registry-related monitoring, audits and IRB review.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||100 participants|
|Target Follow-Up Duration:||12 Weeks|
|Official Title:||Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications|
|Actual Study Start Date :||December 16, 2019|
|Actual Primary Completion Date :||June 30, 2021|
|Actual Study Completion Date :||August 6, 2021|
- Biological: CAM
Cryopreserved Amniotic Membrane
- Incidence of related serious adverse events [ Time Frame: 12 weeks ]Number of related serious adverse events occurred
- Visual Analog Scale [ Time Frame: 12 weeks ]Change in pain score (0-10; higher scores mean worse outcome)
- Change in analgesic use [ Time Frame: 12 weeks ]Change in analgesic use
- Change in wound size [ Time Frame: 12 weeks ]Change in wound size
- Time to complete wound closure [ Time Frame: 12 weeks ]Time to complete wound closure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04222166
|United States, Florida|
|Regenerative Medicine and Pain Management Physicians|
|Gulf Breeze, Florida, United States, 32563|
|United States, New Jersey|
|Foot and Ankle Specialists of South Jersey|
|Voorhees, New Jersey, United States, 08043|
|Study Chair:||Theodore Heise, PhD||MED Institute Inc.|