Clinical trial NCT06981481: Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction
Official title: Post-marketing Clinical Monitoring of Safety and Performance of the Silimed® Brand Breast Tissue Expander for Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Safety and Performance
Breast Tissue Expander
Keywords: post-market
safety
performance
Breast tissue expander
breast reconstruction
Lead sponsor: Silimed Industria de Implantes Ltda
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Born females with indication of breast reconstruction using Silimed brand breast tissue expander.

Brief summary: The study investigates the safety and performance of Silimed® brand breast tissue expander in women born with indication for breast reconstruction. The safety of the breast tissue expander will be evaluated by estimating known and unexpected adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand breast tissue expander will be evaluated by evaluating the assessment of tissue quality and satisfaction by the evaluating physician after implantation.


Eligibility criteria: Inclusion Criteria:

1. provide written informed consent
2. female sex at birth;
3. be 18 years of age or older;
4. have an indication for reconstruction with breast expander + breast implant(s);
5. have a plan to receive an expander with a textured surface from the Silimed® brand + implant breast with textured surface from the Silimed® brand;
6. ability to comply with the protocol throughout the follow-up period.

Exclusion Criteria:

1. breast augmentation without reconstruction in at least one breast;
2. neoplasia of any type (except breast neoplasia), not yet treated or under treatment, or requiring surgical removal at the time of implantation;
3. pregnancy or breastfeeding at the time of implantation;
4. smoking, uncontrolled diabetes, obesity (from grade 2) and ASA III/IV;
5. active infection not yet treated or being treated at any site at the time of implantation;
6. report or record of adverse reactions or intolerance to silicone prior to implantation;
7. immune diseases that affect connective tissue in activity or under treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation;
8. record or report of use of illicit drugs or medications that increase the risk of immediate post-surgical complications (eg, medications that interfere with coagulation);
9. high surgical risk or complications in the immediate post-surgery period, estimated before the implantation;
10. evidence or report of tissue characteristics that are clinically inconsistent with a successful implantation (eg tissues with excessive fibrosis or compromised vascularization);
11. may not have participated in another clinical study up to 6 months before placement of the expander, unless the researcher deems it to be good for the participant and not impact the study;
12. previous treatment with radiotherapy;
13. any other condition that, based on the opinion of the researcher or designee, may prevent the provision of informed consent, make study participation unsafe, compromise adherence to the protocol, complicate the interpretation of study outcome data or otherwise interfere with the achievement of the study objectives.

Primary outcomes:
measure: Adverse events
timeFrame: Through study completion, an average of 1 year
measure: Evaluator's Satisfaction in Relation to expansion
timeFrame: Through study completion, an average of 1 year
measure: Evaluator's Assessment of tissue quality
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Fundação do ABC - Centro universitário FMABC
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital de câncer HCIII (INCA)
Study officials:
affiliation: Hospital de câncer - HCIII (INCA)
name: Marcelo A Bello
role: PRINCIPAL_INVESTIGATOR
References: