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CoolSculpting of the Flank With Alternate Treatment Parameters

9. februar 2021 opdateret af: Zeltiq Aesthetics

Non-Invasive Reduction of Subcutaneous Fat Layer With an Alternative Treatment Parameter

The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

45

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6JIZ6
        • Arbutus Laser Centre
  • Forenede Stater
    • California
      • Sacramento, California, Forenede Stater, 95816
        • Laser & Skin Surgery Center of Northern California
    • Texas
      • Dallas, Texas, Forenede Stater, 75231
        • Dallas Plastic Surgery Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  1. Male or female subjects > 18 years of age and < 65 years of age.
  2. Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
  3. Subject has not had weight change exceeding 10 pounds in the preceding month.
  4. Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
  5. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
  6. Subject has read and signed a written informed consent form.

Exclusion Criteria

  1. Subject has had a surgical procedure(s) in the area of intended treatment.
  2. Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
  3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
  4. Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
  5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
  6. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
  7. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
  8. Subject is taking or has taken diet pills or supplements within the past month.
  9. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
  10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
  11. Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
  12. Subject is lactating or has been lactating in the past 6 months.
  13. Subject has a history of hernia in the areas to be treated.
  14. Subject is unable or unwilling to comply with the study requirements.
  15. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
  16. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CoolSculpting of the Flank With Alternate Treatment Parameters
Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.
Enhed: Zeltiq CoolSculpting System
Ikke-invasiv køling påføres behandlingsområdet med en defineret afkølingshastighed og varighed.
Andre navne:
  • Kryolipolyse
  • Lipolyse

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Number of Device and/or Procedure-Related Adverse Events
Tidsramme: Enrollment through 16 weeks post-treatment visit, which is approximately 5 months
The number of device- or procedure-related adverse events will be tabulated. Adverse event reports are collected throughout the study from enrollment through the 16 week follow-up visit. The investigator determines if there is a relationship between the event and the study device or procedure.
Enrollment through 16 weeks post-treatment visit, which is approximately 5 months
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Tidsramme: Pre-treatment and 16 weeks post-treatment
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the untreated contralateral flank control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated flank as compared to the untreated control flank. Results indicate the fat layer reduction in millimeters.
Pre-treatment and 16 weeks post-treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Pre-treatment Images Correctly Identified.
Tidsramme: 16 weeks post-treatment
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images. Images show both treated and untreated flanks. Reviewers will be practicing dermatologists or plastic surgeons. Reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Criteria for evaluable photos for the purposes of the independent review: subject completed treatments; subject has complete set of baseline photos and post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80% correct identification.
16 weeks post-treatment
Subject Satisfaction
Tidsramme: 16 weeks post-treatment
Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses.
16 weeks post-treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zeltiq Aesthetics

Efterforskere

  • Ledende efterforsker: Suzanne Kilmer, MD, Laser and Skin Surgery Center of Northern California

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. februar 2014

Primær færdiggørelse (Faktiske)

27. juni 2014

Studieafslutning (Faktiske)

27. juni 2014

Datoer for studieregistrering

Først indsendt

4. marts 2014

Først indsendt, der opfyldte QC-kriterier

4. marts 2014

Først opslået (Skøn)

7. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. februar 2021

Sidst verificeret

1. september 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ZA13-005

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kropsfedtforstyrrelse

Kliniske forsøg med Zeltiq CoolSculpting System

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kuwait

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner