Adults 22 to 65, any sex, with Muscle Weakness. 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.
Change in Body Satisfaction Questionnaire From Baseline to 1-Month Post-Treatment Follow-up VisitPrimary· Baseline, 1-month post-treatment follow-up visit
Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ) at the 1-month post-treatment follow-up visit. The scale measures body image using a set of dichotomous items used to describe aspects of shape and appearance. The questionnaire has total score range from 10 to 50. An increase in score (when compared to baseline) reflects the participant's perceived improvement in appearance in the treated region (abdomen). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 1-month
Group
Value
95% CI
Cohort 1
6.2
± 4.9
Cohort 2
4.7
± 6.1
Cohort 3
2.8
± 4.1
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)Primary· AE information will be collected from the time of enrollment to the final follow-up visit at 3-months following the final treatment.
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a c
Device and/ or Procedure Related AEs
Group
Value
95% CI
Cohort 1
1
Cohort 2
0
Cohort 3
0
SADEs
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected from the time of enrollment through the 8-week post-treatment follow-up visit, approximately 3 months..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zeltiq Aesthetics
Last refreshed: 2 July 2025
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/NCT04199312.