Clinical study

What the Slimiser clinical study shows

This page details the methodology, quantitative results and limitations of the clinical study behind the results shown on this site, along with the preclinical studies that preceded it. We publish this summary for transparency: figures used elsewhere on the site (e.g. "up to −5 cm waist reduction") come from this study, and no other.

Title: Safety and efficacy evaluation of the Slimiser convergent-ultrasound body-remodeling device
Investigator: Dr Michel Cadot, dermatologist, with Magalie Daniel and Elian Lati
Site: Longjumeau Hospital (Essonne, France); histological and biochemical analyses: BIO-EC Laboratory, France
Sponsor: Laboratoire Synthebio (which also lent the device used for the study — conflict of interest disclosed below)
Period: 19 October 2015 to 3 February 2016
Regulatory framework: favorable opinion from the Comité de Protection des Personnes (CPP) Île-de-France II dated 16 October 2015, ID-RCB/EUDRACT 2014-A00474-43. Conducted under Good Clinical Practice, EN ISO 14155, and directive 93/42/EEC (Annex VIII, section 2-2).

Clinical study methodology

Nineteen women, aged 35 to 55 (mean 45 ± 10), with a BMI between 23.7 and 35.8, were treated on the abdominal area. One group received a single session (followed up at day 28), a second group received two sessions two weeks apart (followed up at day 42). All patients were treated at a "medium" setting (50% of the device's maximum parameters), identical for everyone, delivering the same ultrasound energy dose to all patients rather than individualising settings.

Efficacy was measured via constant-tension tape waist measurements, standardised photographs, and a self-assessment questionnaire. Safety was monitored with blood tests at five time points (triglycerides, glycerol, total cholesterol, LDL, HDL, β-HCG, lipase, creatinine, urea — 180 analyses in total) and a dermatological exam before/after each session.

Safety results

2 / 870adverse events (transient superficial erythema) out of 870 bell applications

0significant change in circulating lipids or pancreatic enzymes

0notable weight variation over the study period

Both erythema cases were superficial and transient: one resolved the same evening, the other within a week. No other adverse event was reported.

Efficacy results

Waist-circumference reduction varied between patients: some had little or no measurable reduction, others had a reduction of up to 4 to 5 cm after one to two sessions. A second treatment, performed two weeks after the first, improved results by around 20% on average compared to a single session. Body weight remained stable throughout the follow-up period.

90%of patients felt no discomfort during treatment

100%felt no pain in the days following treatment

70–80%reported a flatter, firmer abdomen and reduced dimpling

100% of patients said they would want further sessions (excluding the extra blood draw).

Before the clinic: preclinical studies

Ahead of the clinical study, five preclinical protocols (BIO-EC, France) were run on full-thickness human skin explants (epidermis, dermis, subcutaneous fat) from abdominoplasty procedures, to determine the ultrasound parameters to use. Histological analysis showed targeted alterations of adipocytes and fat-tissue septa in treated tissue, with preserved epidermal and dermal structures. In the key study (13E2738, 38-year-old donor), the selected condition increased triglycerides by +27%, free fatty acids by +46% and glycerol by +18% released into the culture medium after 2 days compared to the untreated control — three concordant biochemical markers of measurable adipolytic activity. A second, independent study (11E2300) confirmed increased triglyceride release (roughly +16%).

Study limitations

Small sample size: 19 patients, single center.
Open-label, no placebo arm: there was no sham-treatment control group, and neither patients nor evaluators were blinded.
Variable results between patients: some observed only a small or no reduction in waist circumference.
Not yet published in a peer-reviewed journal; it did, however, receive a favorable opinion from a Comité de Protection des Personnes and was conducted under EN ISO 14155.
Conflict of interest: the study was funded by Laboratoire Synthebio, which markets the Slimiser device and lent the unit used to conduct it.

Individual results may vary depending on the patient, treated area, and tissue characteristics. This information is provided for informational purposes and does not replace a personalised consultation with a qualified healthcare professional.