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NCT05945329RECRUITINGanonymous

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

Sponsor

Source record

C. R. Bard

Phase

Source record

NA

Modality

AI-normalized

medical device

Target

AI-normalized

Capsular Contracture After Breast Implant Augmentation

Indication / condition

AI-normalized

Capsular Contracture Associated With Breast Implant

Intervention

Source record

GalaFLEX LITE™ Scaffold, Standard surgery

Source & freshness

Source record

NCT ID

NCT05945329

Original source

ClinicalTrials.gov

Source last updated

May 22, 2026

Ingested at

May 30, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT05945329

Title

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

Sponsor

C. R. Bard

Status

RECRUITING

Phase

NA

Condition raw

Capsular Contracture Associated With Breast Implant

Condition normalized

Capsular Contracture Associated With Breast Implant

Modality raw

Capsular Contracture Associated With Breast Implant

Modality normalized

medical device

Target raw

Capsular Contracture After Breast Implant Augmentation

Target normalized

Capsular Contracture After Breast Implant Augmentation

Interventions

GalaFLEX LITE™ Scaffold, Standard surgery

Public preview

Source record

C. R. Bard is conducting a multi-center, randomized controlled trial to evaluate the safety and effectiveness of the GalaFLEX LITE™ Scaffold in reducing capsular contracture recurrence in breast augmentation patients. The study aims to enroll between 250 and 530 subjects and compares the scaffold's performance against standard surgical procedures.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

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

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT05945329

Status

RECRUITING

Phase

NA

Sponsor

C. R. Bard

Executive brief

Investment-Ready Snapshot

C. R. Bard is conducting a multi-center, randomized controlled trial to evaluate the safety and effectiveness of the GalaFLEX LITE™ Scaffold in reducing capsular contracture recurrence in breast augmentation patients. The study aims to enroll between 250 and 530 subjects and compares the scaffold's performance against standard surgical procedures.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedMay 22, 2026
Internal syncJun 05, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT05945329

Indication

Capsular Contracture Associated With Breast Implant

Modality

medical device

Target

Capsular Contracture After Breast Implant Augmentation

Intervention

GalaFLEX LITE™ Scaffold, Standard surgery

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.