Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmen… (NCT05945329) | Clinical Trial Compass
RecruitingNot Applicable
Study of GalaFLEX LITEâ„¢ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
United States250 participantsStarted 2024-12-12
Plain-language summary
Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITEâ„¢ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery with no supportive matrix or acellular dermal matrix (ADM). Subjects will be randomized 2:1 to receive either GalaFLEX LITEâ„¢ Scaffold or standard care (no ADM or matrix placement). This study is designed using an adaptive approach. The number of the treated breasts will range between 250 and 530.
Who can participate
Age range22 Years – 66 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Genetically female ≥22 and ≤66 years of age;
✓. Breast augmentation subject with capsular contracture (Baker grade III or IV);
✓. Desired a new implant with no more than a 25% increase in implant size (not to exceed a volume increase greater than 150cc compared to the existing implant);
✓. Planned revision approach via inframammary fold (IMF) incision;
✓. Willing and able to comply with the study procedures including the 2-year follow-up visit;
✓. Lives within 3 hours driving distance from the investigator site; and,
✓. Provision of signed and dated informed consent form.
Exclusion criteria
✕. BMI \<18 or \>35
✕. Existing and/or replacement implant size \> 800 cc
✕. Had ≥2 capsular contracture revisions on the breast(s) intended for treatment
What they're measuring
1
Effectiveness of GalaFLEX LITEâ„¢ Scaffold for the stabilization of the implant pocket
✕. Has an extra-capsular rupture (breast implant silicone gel or saline has leaked outside of the capsule) in breast(s) intended for treatment
✕. Has prior use of a matrix (synthetic or biologic) in the breast(s) intended for treatment.
✕. Abnormal findings on diagnostic imaging within 1-year of study enrollment (mammogram for patients ≥35 years old; MRI for patients \<35 years old or breast ultrasound if MRI is contraindicated)
✕. Has symptoms consistent with Breast Implant Illness (BII)Systemic Symptoms Associated with Breast Implants (SSBI)
✕. Infection present in the breast (day of surgery exclusions are noted in Section 5.3)