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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RECRUITING
NA
2400 participants
INTERVENTIONAL
2025-05-01
2037-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Primary Augmentation
Subjects age 22 and over, indicated to increase breast size
Silicone gel-filled breast implants - Motiva Implants®
Breast Surgery
Revision Augmentation
Revision surgery to correct or improve the results of a previous breast augmentation
Silicone gel-filled breast implants - Motiva Implants®
Breast Surgery
Control Group
Aesthetic procedure other than breast implant surgery
Aesthetic Surgery
Aesthetic procedure other than breast implant surgery
Interventions
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Silicone gel-filled breast implants - Motiva Implants®
Breast Surgery
Aesthetic Surgery
Aesthetic procedure other than breast implant surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is seeking one of the following procedures: -Primary Breast Augmentation: age 22 and over, indicated to increase breast size -Revision Breast Augmentation: removal and replacement of breast implants (revision) to correct or improve the results of a previous breast augmentation
* Patient has adequate tissue available to cover implant(s)
* Willingness to follow all study requirements
* Signs an Informed Consent
* Agrees to have device returned to the Sponsor, if explanted
* Willing to undergo Computed Tomography Scan (CT), ultrasound, or MRI evaluation, if medically advised
* Is 22 years of age or older
* Female
* Is a candidate for aesthetic surgery (such as liposuction, rhinoplasty, face-lift)
* Signs an Informed Consent
* Willingness to follow all study requirements
Exclusion Criteria
* Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration, compromised vascularity, history of compromised wound healing)
* Has an active infection anywhere in their body
* Is pregnant or nursing, or has had a full-term pregnancy or lactated within 6 months of enrollment
* Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and/or significant postoperative complications
* Has any medical condition such as obesity (BMI \>40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and/or significant postoperative complications
* Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others
* Has a history of psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure
* Has been implanted with any non-FDA approved breast implant
* Has been implanted with any silicone implant other than breast implants
* HIV positive (based on medical history)
* Has been diagnosed with Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)
* Has a history of silicone implants (anywhere in the body)
* Plans to undergo silicone breast implant surgery during the course of the study
* Has an active infection anywhere in their body
* Has a history of cancer (except skin cancer)
* Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and/or significant postoperative complications
* Has any medical condition such as obesity (BMI \>40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and/or significant postoperative complications
* Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others
22 Years
FEMALE
Yes
Sponsors
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Motiva USA LLC
INDUSTRY
Responsible Party
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Locations
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J. Gerald Minniti, M.D., F.A.C.S.
Beverly Hills, California, United States
AESTHETX Center
Camp Pendleton, California, United States
Align Surgical Associates Inc
San Francisco, California, United States
Schwartz Aesthetic Institute
Westlake Village, California, United States
The Center for Cosmetic Surgery
Denver, Colorado, United States
Advanced Plastic Surgery, LLC
Washington D.C., District of Columbia, United States
Careaga Plastic Surgery
Coral Gables, Florida, United States
Renee Burke Plastic Surgery, Aesthetics, & Med Spa
South Barrington, Illinois, United States
CaloAesthetics® Plastic Surgery Center
Louisville, Kentucky, United States
The Wall Center for Plastic Surgery
Shreveport, Louisiana, United States
Center for Plastic Surgery
Chevy Chase, Maryland, United States
Parkcrest Plastic Surgery
St Louis, Missouri, United States
Delaware Valley Plastic Surgery
Cherry Hill, New Jersey, United States
Caroline A. Glicksman MD
Sea Girt, New Jersey, United States
Mark D. Epstein, MD, FACS Center for Aesthetic Surgery
Hauppauge, New York, United States
Neinstein Plastic Surgery
New York, New York, United States
HKB Cosmetic Surgery
Charlotte, North Carolina, United States
Capizzi, MD Cosmetic Surgery & Med Spa
Charlotte, North Carolina, United States
Restora Austin Plastic Surgery Center
Austin, Texas, United States
Austin Plastic Surgeon
Austin, Texas, United States
Kristy Hamilton MD, FACS
Houston, Texas, United States
North Texas Plastic Surgery
Southlake, Texas, United States
The Plastics Clinic & SPA
South Jordan, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Samantha Miles
Role: primary
Kamakshi Zeidler, MD, FACS
Role: primary
Thomas Satterwhite, MD
Role: primary
Stephanie Cohen, RN
Role: primary
Jen Atkinson
Role: primary
Troy Pittman, MD, FACS
Role: primary
Barbara Garcia
Role: primary
Luiza Ramanoska
Role: primary
Michael Bradley Calobrace, MD, FACS
Role: primary
Terry Brantley
Role: primary
Jodi Marvin
Role: backup
Diana Altman, RN
Role: primary
Patricia McGuire, MD, FACS
Role: primary
Evan Sorokin, MD
Role: primary
Caroline Glicksman, MD, FACS
Role: primary
Kimberly Wagner
Role: primary
Anne Steve, MD
Role: primary
Devin B. White
Role: primary
Peter Capizzi, MD, FACS
Role: primary
Ashley Gordon, MD, FACS
Role: primary
Johnny Franco, MD
Role: primary
Liliana Hernandez
Role: primary
Sacha Obaid, MD
Role: primary
Jerry Chidester, MD, FACS
Role: primary
References
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Teuwen MMH, Knaapen IRE, Vliet Vlieland TPM, Schoones JW, van den Ende CHM, van Weely SFE, Gademan MGJ. The use of PROMIS measures in clinical studies in patients with inflammatory arthritis: a systematic review. Qual Life Res. 2023 Oct;32(10):2731-2749. doi: 10.1007/s11136-023-03422-0. Epub 2023 Apr 27.
Sun K, Eudy AM, Harris N, Pisetsky DS, Criscione-Schreiber LG, Sadun RE, Doss J, Clowse MEB, Rogers JL. Using PROMIS-29 to determine symptom burdens in the context of the Type 1 and 2 systemic lupus erythematosus (SLE) model: a cross sectional study. J Patient Rep Outcomes. 2023 Dec 21;7(1):136. doi: 10.1186/s41687-023-00678-5.
Hinchcliff ME, Beaumont JL, Carns MA, Podlusky S, Thavarajah K, Varga J, Cella D, Chang RW. Longitudinal evaluation of PROMIS-29 and FACIT-dyspnea short forms in systemic sclerosis. J Rheumatol. 2015 Jan;42(1):64-72. doi: 10.3899/jrheum.140143. Epub 2014 Nov 1.
Bingham Iii CO, Gutierrez AK, Butanis A, Bykerk VP, Curtis JR, Leong A, Lyddiatt A, Nowell WB, Orbai AM, Bartlett SJ. PROMIS Fatigue short forms are reliable and valid in adults with rheumatoid arthritis. J Patient Rep Outcomes. 2019 Feb 21;3(1):14. doi: 10.1186/s41687-019-0105-6.
Bartlett SJ, Gutierrez AK, Andersen KM, Bykerk VP, Curtis JR, Haque UJ, Orbai AM, Jones MR, Bingham CO 3rd. Identifying Minimal and Meaningful Change in a Patient-Reported Outcomes Measurement Information System for Rheumatoid Arthritis: Use of Multiple Methods and Perspectives. Arthritis Care Res (Hoboken). 2022 Apr;74(4):588-597. doi: 10.1002/acr.24501. Epub 2022 Mar 3.
Almalag HM, Almaghlouth I, Dabbagh R, Alsalem AR, Alrajban FN, Algarni SA, Alosaimi FN, Alassaf MI, Alshamrani MA, Alzomia S, Alanazi B, Alalwan T, Alkhalaf A, Bedaiwi M, Omair MA. Prevalence of fatigue functional and social impairment among patients with rheumatic diseases compared to patients without: A cross-sectional comparison. Medicine (Baltimore). 2023 Mar 3;102(9):e33151. doi: 10.1097/MD.0000000000033151.
Other Identifiers
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P230005
Identifier Type: OTHER
Identifier Source: secondary_id
CIP-001005
Identifier Type: -
Identifier Source: org_study_id