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NCT04146584 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
A Phase 2 study, sponsored by Sofwave Medical.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
NCT04146584: Completed Phase 2 study, sponsored by Sofwave Medical.
NCT04146584 is a Phase 2 study that has completed, run by Sofwave Medical. The registered enrollment target is 93 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04146584, a Phase 2 study, has completed, sponsored by Sofwave Medical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
Study Summary
This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.
Primary Outcome
Evaluate the clinical efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by independent masked evaluators. The two independent masked evaluators would be delivered a presentation with images randomly ordered for 'before' and 'after'. Each investigator would have to guess the correct 'after' image. Both investigators must agree on more than 50% of the cases to match success criteria. Each treated zone (Eyebrows, Neck \& Submental)
Interventions
- DEVICE Sofwave Treatments
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2019-11-20 |
| Est. Completion | 2021-03-30 |
| Phase | Phase 2 |
What the finished NCT04146584 record still lists
NCT04146584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which Sofwave Treatments is the first listed.
NCT04146584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04146584 about?
NCT04146584 is a clinical study titled "Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow". This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.
What is the current status of trial NCT04146584?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2019-11-20. Estimated completion is 2021-03-30.
What interventions are being tested in trial NCT04146584?
The interventions under investigation include: Sofwave Treatments (DEVICE).
Who is sponsoring clinical trial NCT04146584?
This trial is sponsored by Sofwave Medical, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04146584's enrollment target sits among peer trials
93 766th of 2000 higher than 1,234 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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