Breast ImplantMotiva PASNCT06938399
Motiva Implants® Post-Approval Study
A study testing Silicone gel-filled breast implants - Motiva Implants® and Aesthetic Surgery in people with Breast Implant, run by Motiva USA LLC at 33 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Implant
- What is being tested?
- Silicone gel-filled breast implants - Motiva Implants® and Aesthetic Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 33 sitesUnited States
- Study dates
- 1 May 2025to 31 Jul 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
33 sites in 1 country. Contact the study team or a site near you to ask about taking part.
33 sites in 1 country
United States33 sites, 33 recruiting
- Recruiting
Restora Austin Plastic Surgery Center
Austin, Texas, 78705
Ashley Gordon, MD, FACS, 512-371-8817, ashleygordonmd@gmail.com
Ashley Gordon, MD, FACS
- Recruiting
Austin Plastic Surgeon
Austin, Texas, 78758
Johnny Franco, MD, 512-334-9917, Jchervanik@morebeautifulyou.com
Johnny Franco, MD
- Recruiting
Belcara Health
Baltimore, Maryland, 21209
Sarah McMillan, MD, (410) 296-0414, drmcmillan@belcarahealth.com
Sarah McMillan, MD
- Recruiting
The Practice Healthcare
Beverly Hills, California, 90210
Holly Contreras, hollyc@thepracticehealthcare.com
Kelly Killeen, MD, FACS
- Recruiting
J. Gerald Minniti, M.D., F.A.C.S.
Beverly Hills, California, 90212
Samantha Miles, 310-275-004, samantha@drminniti.com
J. Gerald Minniti, MD, FACS
- Recruiting
AESTHETX Center
Camp Pendleton, California, 95008
Kamakshi Zeidler, MD, FACS, 408-559-7177, drz@aesthetx.com
Kamakshi Zeidler, MD, FACS
- Recruiting
HKB Cosmetic Surgery
Charlotte, North Carolina, 28078
Devin B. White, 704-659-9000, devin@hkbsurgery.com
Gaurav Bharti, MD, FACS
- Recruiting
Capizzi, MD Cosmetic Surgery & Med Spa
Charlotte, North Carolina, 28203
Peter Capizzi, MD, FACS, 704-655-8988, patientcare@capizzimd.com
Peter Capizzi, MD, FACS
- Recruiting
Delaware Valley Plastic Surgery
Cherry Hill, New Jersey, 08003
Evan Sorokin, MD, 856-797-0202, esorokin@delawarevalleyplasticsurgery.com
Evan Sorokin, MD
- Recruiting
Center for Plastic Surgery
Chevy Chase, Maryland, 20815
Diana Altman, RN, 301-888-7264, Diana@cpsdocs.com
Samir. S Rao, MD, FACS
- Recruiting
Iteld Plastic Surgery
Chicago, Illinois, 60642
Lawrence Iteld MD, 312-757-4505, Info@driteld.com
- Recruiting
Careaga Plastic Surgery
Coral Gables, Florida, 33134
Barbara Garcia, 305-960-7511, bgarcia@absolutemedicalcenter.com
Daniel Carega, MD, FACS
- Recruiting
Dallas Day Surgery of Texas North
Dallas, Texas, 75231
Barbie Reed, RN, barbie.reed@dpsi.org
Sam Jejurikar, MD, MBA
- Recruiting
The Center for Cosmetic Surgery
Denver, Colorado, 80401
Jen Atkinson, 303-907-0077, leads@denverccs.com
Andrew Wolfe, MD, FACS
- Recruiting
Southwest Plastic Surgery
El Paso, Texas, 79936
Marcela Aguilar, 915-590-7900, marcy@swplasticsurgery.com
Francisco Agullo, MD
- Recruiting
Mark D. Epstein, MD, FACS Center for Aesthetic Surgery
Hauppauge, New York, 11788
Kimberly Wagner, 631-689-1100, kwagner@epsteinplasticsurgery.com
Mark Epstein, MD, FACS
- Recruiting
Aesthetic Center for Plastic Surgery
Houston, Texas, 77024
Kirk Zihlman Clinical Research Director, 832-647-3417, kzihlman@kalonaesthetics.com
Kristi Hustak, MD
- Recruiting
Kristy Hamilton MD, FACS
Houston, Texas, 77027
Liliana Hernandez, 713-770-6257, info@drkristyhamilton.com
Kristy Hamilton, MD FACS
- Recruiting
Los Gatos Plastic Surgery
Los Gatos, California, 95032
Emily McMaster, 408-559-7177, emily@sviaplasticsurgery.com
Jerome Liu, MD
- Recruiting
CaloAesthetics® Plastic Surgery Center
Louisville, Kentucky, 40222
Michael Bradley Calobrace, MD, FACS, 502-814-3016, SurgeryCoordinators@calobrace.com
Michael Bradley Calobrace, MD, FACS
- Recruiting
Neinstein Plastic Surgery
New York, New York, 10019
Anne Steve, MD, 212-249-0949, mimi@neinsteinplasticsurgery.com
Anna Steve, MD, FRCSC
- Recruiting
Jones Plastic Surgery
Oklahoma City, Oklahoma, 73120
Lori Podany, RN, (405) 848-3459, nurse@drjustinjones.com
Justin Jones, MD, FACS
- Recruiting
Align Surgical Associates Inc
San Francisco, California, 94115
Thomas Satterwhite, MD, Office@AlignSurgical.com
Thomas Satterwhite, MD
- Recruiting
Caroline A. Glicksman MD
Sea Girt, New Jersey, 08750
Caroline Glicksman, MD, FACS, drglicksman.office@gmail.com
Caroline Glicksman, MD, FACS
- Recruiting
The Wall Center for Plastic Surgery
Shreveport, Louisiana, 71105
Terry Brantley, 318-795-0801, info@wallcenter.com
Jodi Marvin, info@wallcenter.com
- Recruiting
Renee Burke Plastic Surgery, Aesthetics, & Med Spa
South Barrington, Illinois, 60010
Luiza Ramanoska, 847-382-4400, luiza@reneeburkemd.com
Renee Burke, MD
- Recruiting
The Plastics Clinic & SPA
South Jordan, Utah, 84095
KinCaid Fajardo, 801-839-5557, kincaid@theplasticsclinic.com
Bryan Pyfer, MD, FACS
- Recruiting
North Texas Plastic Surgery
Southlake, Texas, 76092
Sandy Roos, MD, 817-587-0884, sandy@northtexasps.com
Sacha Obaid, MD
- Recruiting
Parkcrest Plastic Surgery
St Louis, Missouri, 63141
Patricia McGuire, MD, FACS, 314-569-0130, jodig@parkcrestplasticsurgery.com
Patricia McGuire, MD, FACS
- Recruiting
Alicia Billington Plastic Surgery LLC
St. Petersburg, Florida, 33712
Alicia Billington MD, 727 341 0337, Alicia@billingtonmd.com
- Recruiting
Landis Platic Surgery
Tulsa, Oklahoma, 74114
Dana Mulvey, dana@landisplasticsurgery.com
Lesley V. Landis, MD, FACS
- Recruiting
Advanced Plastic Surgery, LLC
Washington D.C., District of Columbia, 20037
Troy Pittman, MD, FACS, 202-915-2362, drpittman@spmeddc.com
Troy Pittman, MD, FACS
- Recruiting
Schwartz Aesthetic Institute
Westlake Village, California, 91361
Stephanie Cohen, RN, 805-706-0742, rn@drschwartz.com
Michael Schwartz, MD, FACS
About this study
Official title: Motiva Implants® Post-Approval Study (PAS) Protocol for Motiva SmoothSilk® Round Ergonomix® ('Ergonomix®') and SmoothSilk® Round ('Round') Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Revision Augmentation and Other Aesthetic Procedures
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.
Read the detailed description
Prospective, non-randomized, multicenter study including baseline (preoperative), operative, and postoperative data collection annually Years 1-10.
- Conditions
- Breast Implant
- Being tested
- Silicone gel-filled breast implants - Motiva Implants®, Aesthetic Surgery
- Keywords
- Breast Implants, Breast Surgery, Breast Augmentation, Breast Revision, Silicone Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone gel-filled breast implants - Motiva Implants®Device
Also called Breast Augmentation
Breast Surgery
Aesthetic SurgeryOther
Also called Aesthetic procedure
Aesthetic procedure other than breast implant surgery
| Study group | Role | What they receive |
|---|---|---|
| Primary Augmentation | Other | Subjects age 22 and over, indicated to increase breast size Receives: Device: Silicone gel-filled breast implants - Motiva Implants® |
| Revision Augmentation | Other | Revision surgery to correct or improve the results of a previous breast augmentation Receives: Device: Silicone gel-filled breast implants - Motiva Implants® |
| Control Group | Other | Aesthetic procedure other than breast implant surgery Receives: Other: Aesthetic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Analysis of Patient-Reported safety and satisfaction collected through a Follow-Up Questionnaire and 5-point Likert scale
Measured: 10 Years
Assess the impact of RFID on imaging
Frequency of imaging impact among participants implanted with devices containing RFID
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 May 2025
- Primary completion1 Apr 2037 (estimated)
- Study completion31 Jul 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, 3 arms
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Motiva USA LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938399
- Sponsor's protocol ID
- CIP-001005
- Other IDs
- P230005
- Acronym
- Motiva PAS
- Status last verified
- Oct 2025
- First submitted
- 14 Apr 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37103773Sun 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.
PubMed 38127169Hinchcliff 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.
PubMed 25362656Bingham 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.
PubMed 30790155Bartlett 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.
PubMed 33166066Almalag 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.
PubMed 36862854
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motiva Implants® Post-Approval Study (PAS) Protocol for Motiva SmoothSilk® Round Ergonomix® ('Ergonomix®') and SmoothSilk® Round ('Round') Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Revision Augmentation and Other Aesthetic Procedures
- ClinicalTrials.gov ID
- NCT06938399
- Acronym / sponsor ID
- Motiva PAS / CIP-001005
- Conditions
- Breast Implant
- Keywords
- Breast Implants, Breast Surgery, Breast Augmentation, Breast Revision, Silicone Implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Motiva USA LLCIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Apr 2037 (estimated)
- Study completion
- 31 Jul 2037 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective, non-randomized, multicenter study including baseline (preoperative), operative, and postoperative data collection annually Years 1-10.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multicenter, 3 arms
| Arm | Type | Receives |
|---|---|---|
| Primary Augmentation | Other | Device: Silicone gel-filled breast implants - Motiva Implants®Subjects age 22 and over, indicated to increase breast size |
| Revision Augmentation | Other | Device: Silicone gel-filled breast implants - Motiva Implants®Revision surgery to correct or improve the results of a previous breast augmentation |
| Control Group | Other | Other: Aesthetic SurgeryAesthetic procedure other than breast implant surgery |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silicone gel-filled breast implants - Motiva Implants®Also: Breast AugmentationBreast Surgery | Device | Primary Augmentation, Revision Augmentation |
| Aesthetic SurgeryAlso: Aesthetic procedureAesthetic procedure other than breast implant surgery | Other | Control Group |
Primary outcome
Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants
Time frame: 10 Years
Analysis of Patient-Reported incidence of Connective Tissue Diseases (CTDs) and related systemic symptoms, collected through a questionnaire that includes the PROMIS-29 Survey
2 secondary outcomes
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
Time frame: 10 Years
Assess the impact of RFID on imaging
Time frame: 10 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 37103773Teuwen 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.
- Background: PubMed 38127169Sun 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.
- Background: PubMed 25362656Hinchcliff 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.
- Background: PubMed 30790155Bingham 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.
- Background: PubMed 33166066Bartlett 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.
- Background: PubMed 36862854Almalag 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone gel-filled breast implants - Motiva Implants® and Aesthetic Surgery in people with Breast Implant, run by Motiva USA LLC at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Motiva USA LLC (+506 86263002, CIP-001005+enrollment@establishmentlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06938399, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.