Radiesse® Safety Study For the Treatment of Hands
This trial is active, not recruiting.
|Condition||volume loss in the dorsum of the hand|
|Treatment||radiesse injectable implant and 2% lidocaine hcl|
|Sponsor||Merz Pharmaceuticals, LLC|
|Start date||June 2016|
|End date||September 2018|
|Trial size||250 participants|
|Trial identifier||NCT02904096, P151009, M900311002|
The primary objective of this study is to evaluate the safety of Radiesse implantation for very severe volume loss in the dorsum of the hand at 6 months after treatment.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Los Angeles, CA||Merz Investigative Site||no longer recruiting|
|Sacramento, CA||Merz Investigative Site||no longer recruiting|
|San Diego, CA||Merz Investigative Site||no longer recruiting|
|Vista, CA||Merz Investigative Site||no longer recruiting|
|New York, NY||Merz Investigative Site||no longer recruiting|
|Austin, TX||Merz Investigative Site||no longer recruiting|
|Plano, TX||Merz Investigative Site||no longer recruiting|
|Spokane, WA||Merz Investigative Site||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Comparison of the proportion of device/injection-related severe AEs in the MHGS Grade 4 (Group A) subjects versus the MHGS Grade 2-3 (Group B) subjects
time frame: 6 months
Male or female participants at least 22 years old.
Inclusion Criteria: 1. Has hands rating 2, 3, or 4 on the validated MHGS as determined by a live, masked evaluator. 2. Is at least 22 years of age. 3. Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study. 4. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits and meet all study requirements. Exclusion Criteria: 1. Was a participant in the Radiesse hands pre-market clinical study 2. Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands. 3. Has any medical condition with the potential to interfere with the study or increase the risk of AEs.
|Official title||Radiesse® Post Approval Safety Study For the Treatment of Hands With Moderate to Very Severe Dorsal Volume Loss|
|Description||This is a 2-year post approval safety (PAS) study evaluating the Adverse Event (AE) rate of Merz Hand Grading Scale (MHGS) baseline grade 4 hands (Group A) compared to the AE rate of MHGS baseline grade 2-3 hands (Group B). Subjects will be recruited at each site with the intention to have an equal number of subjects in Group A and Group B. All subjects will receive an initial Radiesse hand treatment in both hands, and up to 3 retreatments in the study. Hands will be assessed by evaluators on the MHGS who will be blinded to group, treatment details, time since last treatment, and number of retreatments.|
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