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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050052 S049/ PAS002 |
| Date Original Protocol Accepted |
11/23/2015
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| Date Current Protocol Accepted |
09/18/2017
|
| Study Name |
Radiesse New Enrollment Study
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| Device Name |
RADIESSE INJECTABLE IMPLANT
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a 2-year, prospective, open-label, new enrollment study in
250 subjects enrolled at up to 12 sites to evaluate the safety and effectiveness of Radiesse implantation for very severe volume loss in the dorsum of the hands in MHGS 4 subjects.
The primary objective is to compare the rate of device/injection- related severe adverse events (AEs) in the Merz Hand Grading Scale (MHGS) 4 group (Group A) versus the MHGS 2/3 group (Group B).
A secondary objective is to assess the effectiveness of Radiesse for very severe volume loss in the dorsum of the hands.
Another secondary objective is to assess the safety of multiple retreatments with Radiesse in the dorsum of the hand.
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| Study Population |
The study population will consist of subjects who are at least 22 years old with hands rated as MHGS 2, 3, or 4. Additional inclusion and exclusion criteria are specified in the protocol. All subjects will receive an initial treatment with Radiesse and have an opportunity to receive up to 3 additional treatments over the course of this study.
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| Sample Size |
A maximum of 250 subjects will be enrolled at a minimum of 5 sites and a maximum of 12 sites in the US.
At 6-months, 244 subjects are expected to provide approximately 80% power to test the hypothesis. With a 5% attrition rate per year, a minimum of 225 evaluable subjects are required to provide 2-year follow-up data.
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| Key Study Endpoints |
The primary safety endpoint is the 6-month rate of devices/injection-related severe AEs.
The secondary endpoints of the study are:
-The rate of device/injection-related severe adverse events at 24 months
-MHGS at 3-months after initial treatment
-MHGS at 3-months following retreatment for those receiving retreatment
-Global Aesthetic Improvement Scale (GAIS) at 3-months after initial treatment
-GAIS at 3-months following retreatment for those receiving
retreatment
-Hand function testing at baseline, study exit, and other collected time points
o Inter-rater correlation of hand function testing results for each
site
o Differences between sites in hand function testing results
Other endpoints of the study are:
-MHGS at 1-, 6-, 12-, 18-, and 24-months after initial treatment
-MHGS at 1-, 6-, 12- and 18-months follow retreatment for those receiving retreatment
-GAIS at 1-, 6-, 12-, 18-, and 24-months after initial treatment
-GAIS at 1-, 6-, 12- and 18-months follow retreatment for those receiving retreatment
-Michigan Hand Outcomes Questionnaire (MHQ) at baseline, study exit, and other collected time points
-Incidence of all adverse events over the course of the study
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| Follow-up Visits and Length of Follow-up |
Subjects will be followed for 24 months.
After screening/enrollment, subjects will be followed at 2 weeks, 1,
3, 6, 7, 12, 13, 18, 19, and 24 months. (The 7 and 19 month visits are only to document serious or medically concerning AEs).
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
256
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| Actual Number of Sites Enrolled |
9
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| Patient Follow-up Rate |
94%
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| Final Safety Findings |
Adverse events include swelling, pain, redness, bruising, difficulty performing activities, itching, loss of sensation, bumps/lumps, and hematoma. Two (2) device/injection-related severe treatment emergent adverse events (swelling) were reported during the study
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| Final Effect Findings |
Majority of subjects in both groups showed at least one point in the Global Aesthetic Improvement Scale (GAIS) when compared to baseline. Re-treatment showed less pronounced GAIS improvement.
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| Study Strengths & Weaknesses |
Strengths: The study findings provide information on long-term safety and effectiveness up to 24 months. The study had a 94% follow-up rate.
Weaknesses: There is no control group. Majority of the subjects (96%) were female. Majority of the subjects (92%) were white
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| Recommendations for Labeling Changes |
The labeling should be updated to reflect the 24-month long term results and detailed information on the duration of adverse events
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