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COMPLETED NA

Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8

NCT04103619 · View on ClinicalTrials.gov ↗

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)

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

FieldValue
Enrollment Target 12 participants
Start Date 2019-05-16
Est. Completion 2021-12-13
Phase NA

Sponsor

InMode MD

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04103619

The ClinicalTrials.gov registry entry for NCT04103619 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InMode MD, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04103619 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04103619?

The interventions under investigation include: AccuTite (DEVICE), AccuTite + Morpheus 8 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04103619?

This trial is sponsored by InMode MD, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial