CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 256 enrolled
Drug / intervention
Radiesse injectable implant and 2% lidocaine HCLdevice
Likely dose
Radiesse injectable implant, 0.2–0.5 cc per bolus, maximum 3 cc (2 syringes) per handAI-extracted
Key inclusion· 3
  • ✓Hands rated 2, 3, or 4 on the validated Modified Hand Grading Scale (MHGS) as determined by a live, masked evaluator
  • ✓At least 22 years of age
  • ✓Willing to avoid other procedures to the dorsum of the hands through end of study
Key exclusion· 4
  • ✕Prior participation in Radiesse hands pre-market clinical study
  • ✕Prior treatment with fat injections or Radiesse in the hands
  • ✕Hand deformities or prior dorsal hand surgery
  • ✕Any medical condition with potential to interfere with study or increase risk of adverse events

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02904096
NCT02904096N/ACompleted
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Radiesse® Post Approval Safety Study For the Treatment of Hands With Moderate to Very Severe Dorsal Volume Loss

Merz North America, Inc.·interventional·Posted Sep 16, 2016·Updated Jan 13, 2020

In Brief

A clinical study evaluating Radiesse injectable implant and 2% lidocaine HCL for Volume Loss in the Dorsum of the Hand. Completed, enrolled 256 participants across 9 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVolume Loss in the Dorsum of the Hand
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 16, 2016
Enrollment StartJun 10, 2016
Primary CompletionJan 9, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.8 years ago

Interventions

Radiesse injectable implant and 2% lidocaine HCLdevice

Radiesse injectable implant injected in small boluses (0.2-0.5cc/bolus). No more than 0.5cc per bolus. No more than 3 cc (2 syringes) will be injected per hand.