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Multi-Center Pilot Study of Cutera truSculpt Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03782545
Recruitment Status : Active, not recruiting
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Brief Summary:
Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.

Condition or disease Intervention/treatment Phase
Treatment for Cellulite on the Stomach and Flanks Device: Cutera truSculpt Device Not Applicable

Detailed Description:
This study will evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.
Masking: None (Open Label)
Masking Description: This is an open label study.
Primary Purpose: Treatment
Official Title: Multi-Center Pilot Study of Cutera truSculpt Device
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Intervention Details:
  • Device: Cutera truSculpt Device
    The Cutera truSculpt Device uses radio frequency (RF) energy to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as temporary reduction in the appearance of cellulite.


Primary Outcome Measures :
  1. Incidence and severity of adverse device effects. [ Time Frame: up to 12 week follow up ]
    Incidence and severity of adverse device effects.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Subject must be able to read, understand and sign the Informed Consent Form.

    2. Female or Male, 18 to 65 years of age (inclusive). 3. Subject has visible fat bulges in the area to be treated. 4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.

    5. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period.

    6. Subject must adhere to the follow-up schedule and study instructions. 7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study.

    8. Willing to have photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.

    9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control prior to enrollment and during the entire course of the study.

Exclusion Criteria:

  1. Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
  2. Any type of prior cosmetic treatment to the target area within 6 months of study participation.
  3. Any prior invasive cosmetic surgery to the target area, such as liposuction.
  4. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
  5. Has metal implant(s) within the body, such as artificial heart valves.
  6. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
  7. History of any disease or condition that could impair wound healing.
  8. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
  9. Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion.
  10. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
  11. Allergy or sensitivity to Tegaderm.
  12. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782545


Locations
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United States, California
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
United States, Illinois
Advanced Dermatology
Glencoe, Illinois, United States, 60022
United States, New York
Union Square Dermatology
New York, New York, United States, 10003
Sponsors and Collaborators
Cutera Inc.

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Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT03782545    
Other Study ID Numbers: C-18-TS-18
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Researchers involved in the study will have access to the final study data.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cellulite
Skin Manifestations
Signs and Symptoms