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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.

Tracking Information
First Submitted Date January 3, 2020
First Posted Date January 9, 2020
Last Update Posted Date August 27, 2021
Actual Study Start Date December 16, 2019
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 6, 2020)
Incidence of related serious adverse events [ Time Frame: 12 weeks ]
Number of related serious adverse events occurred
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 8, 2020)
  • 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
Original Secondary Outcome Measures
 (submitted: January 6, 2020)
  • Change in pain score [ Time Frame: 12 weeks ]
    Change in pain score
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications
Official Title Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 12 Weeks
Biospecimen Not Provided
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.
Condition
  • Orthopedic Disorder
  • Wound
Intervention Biological: CAM
Cryopreserved Amniotic Membrane
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 6, 2020)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date August 6, 2021
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04222166
Other Study ID Numbers 19-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party MED Institute Inc.
Study Sponsor MED Institute Inc.
Collaborators Not Provided
Investigators
Study Chair: Theodore Heise, PhD MED Institute Inc.
PRS Account MED Institute Inc.
Verification Date August 2021