Motiva Implants® Post-Approval Study

NCT06938399 | Recruiting FDA Device

• 2 other identifiers: CIP-001005P230005
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 29

Brief Summary

This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.

Conditions

Breast Implant

Keywords

Breast Implants; Breast Surgery; Breast Augmentation; Breast Revision; Silicone Implants

Outcome Measures

Primary Outcomes (1)

• Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants

  Analysis of Patient-Reported incidence of Connective Tissue Diseases (CTDs) and related systemic symptoms, collected through a questionnaire that includes the PROMIS-29 Survey

  10 Years

Secondary Outcomes (2)

• Investigate the incidence of Reproductive Complications, Cancer Diagnoses, Local Complications in Motiva implanted participants compared to the incidence in control participants, where data collection allows; and investigate patient satisfaction

  10 Years

• Assess the impact of RFID on imaging

  10 Years

Study Arms (3)

Primary Augmentation

OTHER

Subjects age 22 and over, indicated to increase breast size

Device: Silicone gel-filled breast implants - Motiva Implants®

Revision Augmentation

OTHER

Revision surgery to correct or improve the results of a previous breast augmentation

Device: Silicone gel-filled breast implants - Motiva Implants®

Control Group

OTHER

Aesthetic procedure other than breast implant surgery

Other: Aesthetic Surgery

Interventions

Silicone gel-filled breast implants - Motiva Implants® DEVICE

Breast Surgery

Also known as: Breast Augmentation

Primary Augmentation; Revision Augmentation

Aesthetic Surgery OTHER

Aesthetic procedure other than breast implant surgery

Also known as: Aesthetic procedure

Control Group

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2
• 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

Sponsors & Collaborators

• Motiva USA LLC: lead

Study Sites (29)

The Practice Healthcare

Beverly Hills, California, 90210, United States

RECRUITING

J. Gerald Minniti, M.D., F.A.C.S.

Beverly Hills, California, 90212, United States

RECRUITING

AESTHETX Center

Camp Pendleton, California, 95008, United States

RECRUITING

Align Surgical Associates Inc

San Francisco, California, 94115, United States

RECRUITING

Schwartz Aesthetic Institute

Westlake Village, California, 91361, United States

RECRUITING

The Center for Cosmetic Surgery

Denver, Colorado, 80401, United States

RECRUITING

Advanced Plastic Surgery, LLC

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Careaga Plastic Surgery

Coral Gables, Florida, 33134, United States

RECRUITING

Renee Burke Plastic Surgery, Aesthetics, & Med Spa

South Barrington, Illinois, 60010, United States

RECRUITING

CaloAesthetics® Plastic Surgery Center

Louisville, Kentucky, 40222, United States

RECRUITING

The Wall Center for Plastic Surgery

Shreveport, Louisiana, 71105, United States

RECRUITING

Belcara Health

Baltimore, Maryland, 21209, United States

RECRUITING

Center for Plastic Surgery

Chevy Chase, Maryland, 20815, United States

RECRUITING

Parkcrest Plastic Surgery

St Louis, Missouri, 63141, United States

RECRUITING

Delaware Valley Plastic Surgery

Cherry Hill, New Jersey, 08003, United States

RECRUITING

Caroline A. Glicksman MD

Sea Girt, New Jersey, 08750, United States

RECRUITING

Mark D. Epstein, MD, FACS Center for Aesthetic Surgery

Hauppauge, New York, 11788, United States

RECRUITING

Neinstein Plastic Surgery

New York, New York, 10019, United States

RECRUITING

HKB Cosmetic Surgery

Charlotte, North Carolina, 28078, United States

RECRUITING

Capizzi, MD Cosmetic Surgery & Med Spa

Charlotte, North Carolina, 28203, United States

RECRUITING

Jones Plastic Surgery

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Landis Platic Surgery

Tulsa, Oklahoma, 74114, United States

RECRUITING

Restora Austin Plastic Surgery Center

Austin, Texas, 78705, United States

RECRUITING

Austin Plastic Surgeon

Austin, Texas, 78758, United States

RECRUITING

Dallas Day Surgery of Texas North

Dallas, Texas, 75231, United States

RECRUITING

Southwest Plastic Surgery

El Paso, Texas, 79936, United States

RECRUITING

Kristy Hamilton MD, FACS

Houston, Texas, 77027, United States

RECRUITING

North Texas Plastic Surgery

Southlake, Texas, 76092, United States

RECRUITING

The Plastics Clinic & SPA

South Jordan, Utah, 84095, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 37103773 BACKGROUND

• 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.

  PMID: 38127169 BACKGROUND

• 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.

  PMID: 25362656 BACKGROUND

• 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.

  PMID: 30790155 BACKGROUND

• 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.

  PMID: 33166066 BACKGROUND

• 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.

  PMID: 36862854 BACKGROUND

Central Study Contacts

Motiva USA LLC

CONTACT

+506 8761-4436; CIP-001005+enrollment@establishmentlabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, 3 arms

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 1, 2037
• Study Completion (Estimated): July 31, 2037
• Last Updated: March 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)