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NCT04103619 · ClinicalTrials.gov registry record · NA
Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8
A NA study of Periorbital Edema, sponsored by InMode MD.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT04103619: Completed NA study of Periorbital Edema, sponsored by InMode MD.
NCT04103619 is a NA study of Periorbital Edema that has completed, run by InMode MD. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04103619, a NA study of Periorbital Edema, has completed, sponsored by InMode MD.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
1. To establish clinical efficacy, safety and patient satisfaction of reducing lower eyelid convexities or "bags" and/or malar crescents (festoons) with catheter-based injectable RF (InMode AccuTite) and variable depth Fractional RF Microneedle skin rejuvenation (InMode Morpheus8). 2. To determine the relative effectiveness of dual-modality treatment (AccuTite + Morphues8 initial treatment followed by two consecutive Morpheus8 treatments 1 month apart) versus single modality treatment (AccuTite only)
Primary Outcome
Correct identification of the 3 and 6 Months post last treatment photographs from the baseline by at least two of the three blinded reviewers in 75% of the subjects.
Conditions Studied
Interventions
- DEVICE AccuTite
- DEVICE AccuTite + Morpheus 8
Study Locations (2)
Florida
- David Holcomb - Sarasota
Ohio
- Gentile Facial Plastic and Aesthetic Laser Center - Youngstown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-05-16 |
| Est. Completion | 2021-12-13 |
| Phase | NA |
What the finished NCT04103619 record still lists
NCT04103619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Periorbital Edema appearing as the primary indexed condition, and to 2 interventions - of which AccuTite is the first listed.
NCT04103619 reports a single indexed study location in Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT04103619 about?
NCT04103619 is a clinical study titled "Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8". 1. To establish clinical efficacy, safety and patient satisfaction of reducing lower eyelid convexities or "bags" and/or malar crescents (festoons) with catheter-based injectable RF (InMode AccuTite) and variable depth Fractional RF Microneedle skin rejuvenation (InMode Morpheus8). 2. To determine t...
What is the current status of trial NCT04103619?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2019-05-16. Estimated completion is 2021-12-13.
What conditions does trial NCT04103619 study?
This clinical trial studies the following conditions: Periorbital Edema.
What interventions are being tested in trial NCT04103619?
The interventions under investigation include: AccuTite (DEVICE), AccuTite + Morpheus 8 (DEVICE).
Who is sponsoring clinical trial NCT04103619?
This trial is sponsored by InMode MD, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04103619 being conducted?
This trial has 2 study locations across Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04103619's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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