Participant Satisfaction, Effectiveness, and Safety With a Novel Dual-Applicator Cryolipolysis System: A Prospective, Multicountry Study
Bibliographic record
Abstract
BACKGROUND: Cryolipolysis is an effective, well-tolerated noninvasive subcutaneous fat reduction treatment. OBJECTIVE: Assess participant satisfaction, effectiveness, and safety of a dual-applicator cryolipolysis system that can deliver simultaneous treatments. MATERIALS AND METHODS: Adult participants received treatment to the abdomen/flanks (midsection). Participants could also receive treatment to upper arms, thighs, and submental area. Primary end point was participant satisfaction with midsection results at 12 weeks after final treatment. Secondary end points included independent photography review, participant satisfaction with additional body areas, and overall satisfaction. Exploratory end points included 3D imaging of midsection volumetric changes and assessments at 4 weeks after initial treatment. Safety was monitored throughout. RESULTS: Of 110 treated participants, 75% were female. Mean age and body mass index were 43 years and 25.1 kg/m 2 , respectively. Of 96 evaluable participants, 83.3% (80/96) were "satisfied/very satisfied" with midsection results. Reviewers correctly identified 88.0% (81/92) of baseline versus 12 weeks after final treatment midsection images. Mean (SD) subcutaneous fat volume loss was 194.8 (492.3) mL at 12 weeks after final treatment ( p < .001). Visible improvements were noted at 4 weeks after initial treatment by a majority of physician reviewers and participants. Five (4.5%, 5/110) participants reported 7 treatment-emergent adverse device effects. CONCLUSION: The dual-applicator cryolipolysis system demonstrated high participant satisfaction, effectiveness, and safety.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".