Clinical trial NCT04222166: Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications
Official title: Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Disorder
Wound
Lead sponsor: MED Institute Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of related serious adverse events
timeFrame: 12 weeks
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 12 weeks
measure: Change in analgesic use
timeFrame: 12 weeks
measure: Change in wound size
timeFrame: 12 weeks
measure: Time to complete wound closure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Regenerative Medicine and Pain Management Physicians
state: Florida
city: Voorhees
country: United States
facility: Foot and Ankle Specialists of South Jersey
state: New Jersey
Study officials:
affiliation: MED Institute Inc.
name: Theodore Heise, PhD
role: STUDY_CHAIR
References: