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NCT05388617

Study To Assess Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat

Terminated NA Results posted Last updated 29 November 2023
What this trial tests

NA trial testing Brera in Muscle Stimulation in 16 participants. Terminated before completion.

Timeline
10 May 2022
Primary endpoint
24 August 2022
24 August 2022

Quick facts

Lead sponsorCynosure, Inc.
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment16
Start date10 May 2022
Primary completion24 August 2022
Estimated completion24 August 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Cynosure, Inc. — full company profile →

Who can join

18 and older, any sex, with Muscle Stimulation or Abdominal 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.

Number of Subjects Satisfied Primary · 30 days follow up.

The number of subjects satisfied with their treatment will be reported.

GroupValue95% CI
Group A10

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were captured throughout subject participation in the study, approximately 30 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group A
Serious: 0/16 (0%)
Deaths: 0/16
Group B
Serious: 0
Deaths: 0
Other adverse events (4 terms — click to expand)

ReactionSystemGroup AGroup B
Pain/TendernessSkin and subcutaneous tissue disorders
CrampingSkin and subcutaneous tissue disorders
ErythemaSkin and subcutaneous tissue disorders
Muscle TwitchingSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT05388617 adverse events section.

Sponsor's own description

The intended use of the device in this study to assess the safety and efficacy of the adhesive electrodes for muscle stimulation and the treatment of abdominal fat on the abdomen and/or flanks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Cynosure, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT05388617.

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