Orthopedic DisorderNCT04222166
Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications
An observational study of Orthopedic Disorder and Wound, run by MED Institute Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Orthopedic Disorder, Wound
- What is being tested?
- CAM
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Dec 2019to 6 Aug 2021
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients are excluded from registry enrollment if they are under the age of 22 years.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Regenerative Medicine and Pain Management Physicians
Gulf Breeze, Florida, 32563
Foot and Ankle Specialists of South Jersey
Voorhees Township, New Jersey, 08043
About this study
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.
Read the 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
- Being tested
- CAM
- Medical subject headings
- Musculoskeletal Diseases, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMBiological
Cryopreserved Amniotic Membrane
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of related serious adverse events
Number of related serious adverse events occurred
Measured: 12 weeks
Secondary outcomes (4)
Visual Analog Scale
Change in pain score (0-10; higher scores mean worse outcome)
Measured: 12 weeks
Change in analgesic use
Change in analgesic use
Measured: 12 weeks
Change in wound size
Change in wound size
Measured: 12 weeks
Time to complete wound closure
Time to complete wound closure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start16 Dec 2019
- Primary completion30 Jun 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- MED Institute Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theodore Heise, PhD, Study chair, MED Institute Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222166
- Sponsor's protocol ID
- 19-003
- Status last verified
- Aug 2021
- First submitted
- 3 Jan 2020
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications
- ClinicalTrials.gov ID
- NCT04222166
- Acronym / sponsor ID
- 19-003
- Conditions
- Orthopedic Disorder, Wound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MED Institute Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients are excluded from registry enrollment if they are under the age of 22 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAMCryopreserved Amniotic Membrane | Biological | – |
Primary outcome
Incidence of related serious adverse events
Time frame: 12 weeks
Number of related serious adverse events occurred
4 secondary outcomes
Visual Analog Scale
Time frame: 12 weeks
Change in analgesic use
Time frame: 12 weeks
Change in wound size
Time frame: 12 weeks
Time to complete wound closure
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Heise, PhD study chair
MED Institute Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder and Wound, run by MED Institute Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of related serious adverse events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.