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NCT02736825 · ClinicalTrials.gov registry record · NA
Simulines Non-Inferiority Pivotal Study
A NA study, sponsored by Ulthera.
- Terminated
- Registry status
- NA
- Development phase
- 262
- Enrollment target
NCT02736825: Clinical Trial NA study, sponsored by Ulthera.
NCT02736825 is a NA study that was terminated before completion, run by Ulthera. The registered enrollment target is 262 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02736825, a NA study, was terminated before completion, sponsored by Ulthera.
- TERMINATED
- Registry status
- NA
- Development phase
- 262 participants
- Enrollment target
Study Summary
Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.
Primary Outcome
Participant response was defined as \>=20 mm\^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 90-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between
Interventions
- DEVICE Ulthera System with standard transducer
- DEVICE Ulthera System with prototype 2 simulines transducer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2016-04-11 |
| Est. Completion | 2017-04-25 |
| Phase | NA |
Why NCT02736825 stopped before completion
NCT02736825 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Ulthera System with standard transducer is the first listed.
NCT02736825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02736825 about?
NCT02736825 is a clinical study titled "Simulines Non-Inferiority Pivotal Study". Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatmen...
What is the current status of trial NCT02736825?
This trial is currently terminated. It is a NA study. The enrollment target is 262 participants. The study started on 2016-04-11. Estimated completion is 2017-04-25.
What interventions are being tested in trial NCT02736825?
The interventions under investigation include: Ulthera System with standard transducer (DEVICE), Ulthera System with prototype 2 simulines transducer (DEVICE).
Who is sponsoring clinical trial NCT02736825?
This trial is sponsored by Ulthera, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02736825's enrollment target sits among peer trials
262 397th of 2000 higher than 1,604 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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