Shockwave in Postoperative Breast Reconstruction Fibrosis

Conditions

• Fibrosis Breast

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pulsed Acoustic Cellular Expression therapy — DEVICE
  The therapy involves the delivery of targeted acoustic energy that initiates cellular mechanotransduction pathways, inducing beneficial biological responses such as enhanced angiogenesis, modulation of fibroblast proliferation and differentiation, and reorganization of aberrant extracellular matrix components.

Study Details

This study evaluates the potential for extracorporeal shockwave therapy to reduce post-operative soft tissue fibrosis.

Key Dates

Start date

Oct 1, 2024

Status verified

Apr 2026

Primary completion

May 31, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Control
  The control arm receives eight sessions of a sham (placebo) version of the therapy.
• Experimental: Intervention
  The intervention arm receives eight sessions of Pulsed Acoustic Cellular Expression (PACE) therapy delivered twice weekly for four weeks at level E2

Primary Outcome Measure

Subcutaneous Fibrosis Mass [ Time Frame: One month ]

Central Contacts

• Antoinette Nguyen
  312-695-6022
  [email protected]

Locations (1)

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