Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications

NCT ID: NCT04222166

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2021-08-06

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.

Conditions

Orthopedic Disorder; Wound

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

CAM

Cryopreserved Amniotic Membrane

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MED Institute Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore Heise, PhD

Role: STUDY_CHAIR

MED Institute Inc.

Locations

Regenerative Medicine and Pain Management Physicians

Gulf Breeze, Florida, United States

Foot and Ankle Specialists of South Jersey

Voorhees Township, New Jersey, United States

Countries

United States

Other Identifiers

19-003

Identifier Type: -

Identifier Source: org_study_id