Capsular Contracture of Breast ImplantNCT07810231
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
An observational study of Capsular Contracture of Breast Implant, run by Research Inc at 1 site in Colombia.
Trial summary
This prospective breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Capsular Contracture of Breast Implant
- What is being tested?
- Breast Implant Exposure and Standardized Capsular Contracture Assessment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 3,000 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jan 2014to 15 Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult women with aesthetic breast implants and no clinically significant capsular contracture at cohort entry.
Who may be able to join
- Female sex and age 18 years or older.
- Aesthetic breast augmentation with permanent silicone or saline implants under the final protocol.
- Baker grade I or II in the analyzed breast at cohort entry, confirmed by standardized examination.
- Known implantation date or year and known pocket plane, incision route, surface texture, and volume.
- Ability to complete annual clinical assessment for up to five years.
- Written informed consent.
Who cannot join
- Baker grade III or IV contracture at cohort entry in the analyzed breast.
- Reconstructive implantation after mastectomy or major trauma.
- Tissue expander.
- Active breast infection or open wound at enrollment.
- Planned immediate implant exchange or explantation.
- Missing core implant or operative data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
IQ interquirofanos
Medellín
juan Velez, MD, Plastic surgeon, +573054511588, direccion.medica@iqinterquirofanos.com
About this study
This prospective breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture. Women with Baker grade I or II aesthetic implants at enrollment will undergo standardized annual assessments for up to five years. The primary outcome is time to incident Baker grade III or IV contracture. Progression, pain, imaging, treatment, and patient-reported outcomes will also be described.
Read the detailed description
Women with aesthetic breast implants and no clinically significant contracture at cohort entry will be enrolled into a dynamic surveillance cohort. Operative and device information will be verified from records. Trained assessors will apply a locked Baker grading protocol annually, supported by photographs, symptom assessment, and imaging. Suspected incident Baker III/IV contracture will undergo independent confirmation and operative verification when available. Delayed-entry survival models will estimate the independent effects of implant age, plane, incision, texture, and volume while accounting for bilateral implants and competing implant removal.
- Conditions
- Capsular Contracture of Breast Implant
- Being tested
- Breast Implant Exposure, Standardized Capsular Contracture Assessment
- Keywords
- Capsular Contracture, Baker Grade, Breast Implant, Pocket Plane, Incision, Surface Texture, Implant Volume, Time-to-Event
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Implant ExposureDevice
Implant-level data include age, laterality, material, surface texture, shape, volume, pocket plane, incision route, primary or revision placement, manufacturer/lot when available, and concomitant mastopexy or fat grafting. Linked arm/group(s): Breast Implant Capsule Surveillance Cohort.
Standardized Capsular Contracture AssessmentDiagnostic test
Two trained assessors will apply a standardized Baker grading protocol, with breast firmness, distortion, pain, and imaging recorded. Suspected grade III/IV events will undergo central review or operative confirmation when surgery occurs. Linked arm/group(s): Breast Implant Capsule Surveillance Cohort.
| Study group | Role | What they receive |
|---|---|---|
| Breast Implant Capsule Surveillance Cohort | Women with Baker grade I or II implants are followed prospectively. Implant and operative characteristics are modeled as exposures. Receives: Device: Breast Implant Exposure; Diagnostic Test: Standardized Capsular Contracture Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Incident Baker Grade III or IV Capsular Contracture
Implant-level time from cohort entry to the first confirmed clinically significant contracture. Grade III is visible distortion/firmness and grade IV includes pain under the locked examination manual. Bilateral implants will be clustered by participant.
Measured: From cohort entry through years of prospective follow-up. 10 years
Secondary outcomes (1)
Capsular Contracture-Free Survival by Implant Age
Probability of remaining free of Baker grade III/IV contracture at prespecified implant ages, estimated with delayed-entry survival methods when prevalent implants are included.
Measured: Prospective follow-up through 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start12 Jan 2014
- Primary completion1 Jan 2026
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Capsular Contracture of Breast ImplantStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- juan velez, MD, plastic surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810231
- Sponsor's protocol ID
- 021
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not contempled in the patient informed consent
Publications
Bachour Y, Bargon CA, de Blok CJM, Ket JCF, Ritt MJPF, Niessen FB. Risk factors for developing capsular contracture in women after breast implant surgery: A systematic review of the literature. J Plast Reconstr Aesthet Surg. 2018 Sep;71(9):e29-e48. doi: 10.1016/j.bjps.2018.05.022. Epub 2018 Jun 9.
PubMed 29980456Calobrace MB, Stevens WG, Capizzi PJ, Cohen R, Godinez T, Beckstrand M. Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):20S-28S. doi: 10.1097/PRS.0000000000004351.
PubMed 29595715Christodoulou N, Secanho M, Kokosis G, Malgor RD, Winocour J, Yu JW, Mathes DW, Kaoutzanis C. Capsular contracture in breast reconstruction: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2024 Nov;98:131-143. doi: 10.1016/j.bjps.2024.08.057. Epub 2024 Aug 17.
PubMed 39244792Stevens WG, Nahabedian MY, Calobrace MB, Harrington JL, Capizzi PJ, Cohen R, d'Incelli RC, Beckstrand M. Risk factor analysis for capsular contracture: a 5-year Sientra study analysis using round, smooth, and textured implants for breast augmentation. Plast Reconstr Surg. 2013 Nov;132(5):1115-1123. doi: 10.1097/01.prs.0000435317.76381.68.
PubMed 24056498Liu X, Zhou L, Pan F, Gao Y, Yuan X, Fan D. Comparison of the postoperative incidence rate of capsular contracture among different breast implants: a cumulative meta-analysis. PLoS One. 2015 Feb 13;10(2):e0116071. doi: 10.1371/journal.pone.0116071. eCollection 2015.
PubMed 25680100
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
- ClinicalTrials.gov ID
- NCT07810231
- Acronym / sponsor ID
- 021
- Conditions
- Capsular Contracture of Breast Implant
- Keywords
- Capsular Contracture, Baker Grade, Breast Implant, Pocket Plane, Incision, Surface Texture, Implant Volume, Time-to-Event
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2014 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Sep 2026 (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 prospective breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture. Women with Baker grade I or II aesthetic implants at enrollment will undergo standardized annual assessments for up to five years. The primary outcome is time to incident Baker grade III or IV contracture. Progression, pain, imaging, treatment, and patient-reported outcomes will also be described.
Detailed description
Women with aesthetic breast implants and no clinically significant contracture at cohort entry will be enrolled into a dynamic surveillance cohort. Operative and device information will be verified from records. Trained assessors will apply a locked Baker grading protocol annually, supported by photographs, symptom assessment, and imaging. Suspected incident Baker III/IV contracture will undergo independent confirmation and operative verification when available. Delayed-entry survival models will estimate the independent effects of implant age, plane, incision, texture, and volume while accounting for bilateral implants and competing implant removal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Implant Capsule Surveillance Cohort | – | Device: Breast Implant Exposure, Diagnostic Test: Standardized Capsular Contracture AssessmentWomen with Baker grade I or II implants are followed prospectively. Implant and operative characteristics are modeled as exposures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women with aesthetic breast implants and no clinically significant capsular contracture at cohort entry.
Key inclusion criteria (6 listed)
- Female sex and age 18 years or older.
- Aesthetic breast augmentation with permanent silicone or saline implants under the final protocol.
- Baker grade I or II in the analyzed breast at cohort entry, confirmed by standardized examination.
- Known implantation date or year and known pocket plane, incision route, surface texture, and volume.
- Ability to complete annual clinical assessment for up to five years.
Key exclusion criteria (6 listed)
- Baker grade III or IV contracture at cohort entry in the analyzed breast.
- Reconstructive implantation after mastectomy or major trauma.
- Tissue expander.
- Active breast infection or open wound at enrollment.
- Planned immediate implant exchange or explantation.
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 |
|---|---|---|
| Breast Implant ExposureImplant-level data include age, laterality, material, surface texture, shape, volume, pocket plane, incision route, primary or revision placement, manufacturer/lot when available, and concomitant mastopexy or fat grafting. Linked arm/group(s): Breast Implant Capsule Surveillance Cohort. | Device | Breast Implant Capsule Surveillance Cohort |
| Standardized Capsular Contracture AssessmentTwo trained assessors will apply a standardized Baker grading protocol, with breast firmness, distortion, pain, and imaging recorded. Suspected grade III/IV events will undergo central review or operative confirmation when surgery occurs. Linked arm/group(s): Breast Implant Capsule Surveillance Cohort. | Diagnostic test | Breast Implant Capsule Surveillance Cohort |
Primary outcome
Time to Incident Baker Grade III or IV Capsular Contracture
Time frame: From cohort entry through years of prospective follow-up. 10 years
Implant-level time from cohort entry to the first confirmed clinically significant contracture. Grade III is visible distortion/firmness and grade IV includes pain under the locked examination manual. Bilateral implants will be clustered by participant.
1 secondary outcome
Capsular Contracture-Free Survival by Implant Age
Time frame: Prospective follow-up through 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 9 Sep 2026.
- Background: PubMed 29980456Bachour Y, Bargon CA, de Blok CJM, Ket JCF, Ritt MJPF, Niessen FB. Risk factors for developing capsular contracture in women after breast implant surgery: A systematic review of the literature. J Plast Reconstr Aesthet Surg. 2018 Sep;71(9):e29-e48. doi: 10.1016/j.bjps.2018.05.022. Epub 2018 Jun 9.
- Background: PubMed 29595715Calobrace MB, Stevens WG, Capizzi PJ, Cohen R, Godinez T, Beckstrand M. Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):20S-28S. doi: 10.1097/PRS.0000000000004351.
- Background: PubMed 39244792Christodoulou N, Secanho M, Kokosis G, Malgor RD, Winocour J, Yu JW, Mathes DW, Kaoutzanis C. Capsular contracture in breast reconstruction: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2024 Nov;98:131-143. doi: 10.1016/j.bjps.2024.08.057. Epub 2024 Aug 17.
- Background: PubMed 24056498Stevens WG, Nahabedian MY, Calobrace MB, Harrington JL, Capizzi PJ, Cohen R, d'Incelli RC, Beckstrand M. Risk factor analysis for capsular contracture: a 5-year Sientra study analysis using round, smooth, and textured implants for breast augmentation. Plast Reconstr Surg. 2013 Nov;132(5):1115-1123. doi: 10.1097/01.prs.0000435317.76381.68.
- Background: PubMed 25680100Liu X, Zhou L, Pan F, Gao Y, Yuan X, Fan D. Comparison of the postoperative incidence rate of capsular contracture among different breast implants: a cumulative meta-analysis. PLoS One. 2015 Feb 13;10(2):e0116071. doi: 10.1371/journal.pone.0116071. eCollection 2015.
- Individual participant dataSharing planned: No. not contempled in the patient informed consent
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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.
juan velez, MD, plastic surgery principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Capsular Contracture of Breast Implant, run by Research Inc at 1 site in Colombia.
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 6 inclusion and 6 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. 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 Juan Velez, MD, Plastic surgeon (+57 3054511588, info@velezlara.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Incident Baker Grade III or IV Capsular Contracture (time frame: From cohort entry through years of prospective follow-up. 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 NCT07810231, which also lists 5 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 9 Sep 2026.