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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
Sponsor:
Information provided by (Responsible Party):
MED Institute Inc.

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.

Condition or disease Intervention/treatment
Orthopedic Disorder Wound Biological: CAM

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
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

Intervention Details:
  • Biological: CAM
    Cryopreserved Amniotic Membrane


Primary Outcome Measures :
  1. Incidence of related serious adverse events [ Time Frame: 12 weeks ]
    Number of related serious adverse events occurred


Secondary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 12 weeks ]
    Change in pain score (0-10; higher scores mean worse outcome)

  2. Change in analgesic use [ Time Frame: 12 weeks ]
    Change in analgesic use

  3. Change in wound size [ Time Frame: 12 weeks ]
    Change in wound size

  4. Time to complete wound closure [ Time Frame: 12 weeks ]
    Time to complete wound closure



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
MED Institute Inc.
Investigators
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Study Chair: Theodore Heise, PhD MED Institute Inc.
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Responsible Party: MED Institute Inc.
ClinicalTrials.gov Identifier: NCT04222166    
Other Study ID Numbers: 19-003
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Diseases