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Recruiting Not applicable Interventional

Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation

ClinicalTrials.gov ID: NCT05945329

Public ClinicalTrials.gov record NCT05945329. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Apr 22, 2026, 9:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Randomized, Controlled, Multi-Center Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation

Study identification

NCT ID
NCT05945329
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
C. R. Bard
Industry
Enrollment
250 participants

Conditions and interventions

Interventions

  • GalaFLEX LITE™ Scaffold Device
  • Standard surgery Other

Device · Other

Eligibility (public fields only)

Age range
22 Years to 66 Years
Sex
Female
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 11, 2024
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029
Last update posted
Mar 9, 2026

2024 – 2029

United States locations

U.S. sites
32
U.S. states
16
U.S. cities
29
Facility City State ZIP Site status
Defyne MD Scottsdale Arizona 82521 Recruiting
The Practice Plastic Surgery Beverly Hills California 90210 Recruiting
California Aesthetic Center Huntington Beach California 92647 Recruiting
Donald S Mowlds, MD A Professional Corporation Newport Beach California 92660 Recruiting
Newport Plastic and Reconstructive Surgery Associates Newport Beach California 92660 Recruiting
Stewart Wang MD Inc. Pasadena California 91101 Recruiting
Charlie Chen MD., Corp San Diego California 92107 Recruiting
Tim Sayed MD San Diego California 92121 Withdrawn
Beauty by Buford Lone Tree Colorado 80124 Recruiting
Sanctuary Plastic Surgery Boca Raton Florida 33431 Withdrawn
Careaga Plastic Surgery Miami Florida 33134 Recruiting
Aesthetic Enhancements Plastic Surgery Orlando Florida 32819 Recruiting
Billington Plastic Surgery St. Petersburg Florida 33710 Recruiting
VIVIFY Plastic Surgery Tampa Florida 33606 Recruiting
The Graivier Center Alpharetta Georgia 30005 Recruiting
Monarch Plastic Surgery and Skin Renewal Center Atlanta Georgia 30328 Recruiting
Meridian Plastic Surgery Center Indianapolis Indiana 46290 Recruiting
Reno Tahoe Plastic Surgery Reno Nevada 89511 Recruiting
VIP Plastic Surgery West Long Branch New Jersey 07764 Recruiting
Plastic Surgery Institute of New York New York New York 10036 Recruiting
H/K/B Surgery Huntersville North Carolina 28078 Recruiting
Essential Medical Research Tulsa Oklahoma 74137 Withdrawn
Pittsburgh Center for Plastic Surgery Pittsburgh Pennsylvania 15213 Recruiting
The Plastic Surgery Center of Nashville With HKB Nashville Tennessee 37203 Recruiting
Farah Naz Khan Dallas Texas 75219 Recruiting
Southwest Plastic Surgery El Paso Texas 79936 Recruiting
Aesthetic Center for Plastic Surgery Houston Texas 77024 Recruiting
Hill Country Plastic Surgery San Antonio Texas 78257 Recruiting
Next Stage Clinical Research San Antonio Texas 78258 Recruiting
The Plastics Clinic Draper Utah 84020 Recruiting
Athenix Advanced Plastic Surgery & Aesthetic Center Seattle Washington 98005 Recruiting
Allen Gabriel MD Vancouver Washington 98660 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05945329, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 9, 2026 · Synced Apr 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05945329 live on ClinicalTrials.gov.

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