Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction
NCT ID: NCT03428243
Last Updated: 2018-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
14 participants
OBSERVATIONAL
2017-07-12
2017-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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truSculpt
truSculpt effectiveness after 18 months
truSculpt
Device comparison of Circumference measurement at Baseline vs 18 months post treatment
Interventions
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truSculpt
Device comparison of Circumference measurement at Baseline vs 18 months post treatment
Eligibility Criteria
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Inclusion Criteria
2. Subject has maintained the same weight since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction", within 5% of baseline weight measurement.
Exclusion Criteria
2. Any type of cosmetic treatment to the target area to reduce circumference since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction" e.g., radiofrequency, cryolysis or light-based treatments.
3. Any invasive cosmetic surgery to the target area, such as liposuction, since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction".
4. Newly diagnosed (since enrolling in Protocol C-16-TS11) significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
5. Newly diagnosed or documented (since enrolling in Protocol C-16-TS11) immune system disorders.
6. Current infection, dermatitis, rash or other skin abnormality in the treatment area.
7. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or treatment in the target area since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction".
8. Pregnant or currently breastfeeding.
9. As per the Investigator's discretion, any physical or mental condition which might make unsafe for the subject to participate in this study.
24 Years
60 Years
ALL
Yes
Sponsors
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Cutera Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Ronan, MD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Cutera Research Center
Brisbane, California, United States
Countries
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Other Identifiers
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C-17-TS15
Identifier Type: -
Identifier Source: org_study_id
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