NCT03433430 is a NA clinical trial of truSculpt in Bulging, sponsored by Cutera Inc..

Who is sponsoring NCT03433430?

NCT03433430 is sponsored by Cutera Inc..

What drugs are being tested in NCT03433430?

Interventions in NCT03433430: truSculpt.

What condition does NCT03433430 study?

NCT03433430 studies Bulging, Body Fat.

Is NCT03433430 still recruiting?

NCT03433430 is currently completed. Last updated 18 September 2023.

Are results published for NCT03433430?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-09-18 · How we verify

NCT03433430

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Multi-Center Pilot Study of truSculpt Device

Completed NA Results posted Last updated 18 September 2023

What this trial tests

NA trial testing truSculpt in Bulging in 9 participants. Completed in 7 March 2018.

Timeline

17 August 2017

Primary endpoint
7 March 2018

7 March 2018

Quick facts

Lead sponsor	Cutera Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	17 August 2017
Primary completion	7 March 2018
Estimated completion	7 March 2018
Sites	3 locations across United States

Drugs / interventions tested

truSculpt

Conditions studied

Bulging — all drugs for Bulging →
Body Fat — all drugs for Body Fat →

Sponsor

Cutera Inc.

Who can join

Adults 18 to 65, any sex, with Bulging or Body Fat. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Body Fat Assessment by Investigator Primary · 12 weeks post final treatment

Degree of Improvement in body fat as assessed by Investigator using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, and 0=No Change Higher scores indicate better outcomes

Group	Value	95% CI
truSculpt	1.88	± 1.13

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks post-final treatment, up to 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

truSculpt

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (3 terms — click to expand)

Reaction	System	truSculpt
Erythema	Skin and subcutaneous tissue disorders	—
Pain	Skin and subcutaneous tissue disorders	—
Tenderness	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03433430 adverse events section.

Sponsor's own description

An exploratory pilot study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of truSculpt

Trials testing the same drug.

NCT03428243 — Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction · completed

Other Cutera Inc. trials

Trials by the same sponsor.

NCT06469398 — A Post Market Device Study for the Treatment of Acne · NA · active not recruiting
NCT04695691 — A Device Study for the Treatment of Acne · NA · completed
NCT03782545 — Multi-Center Pilot Study of Cutera truSculpt Device · NA · completed
NCT03424148 — Open-label, Prospective, Multicenter Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment · NA · completed
NCT03424161 — Multi-Center, Clinical Evaluation of the Cutera Secret RF Device · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03433430 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cutera Inc.
Last refreshed: 18 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03433430.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing