Recruiting

Shockwave Therapy

Sponsor:

Northwestern University

Code:

NCT06919042

Conditions

Fibrosis Breast

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pulsed Acoustic Cellular Expression therapy

Study Details

Brief summary:

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

Conditions

Fibrosis Breast

Study ID

NCT06919042

Start date

Oct 1, 2024

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects greater than 18 years of age.
  • Subjects who have undergone plastic surgery procedures and present in the post-operative period with soft tissue firmness suggestive of subcutaneous/parenchymal fibrosis.

Exclusion Criteria:

  • Subjects with cardiac pacemakers
  • Other medical or psychiatric condition that may increase the risk associated with study participation, may complicate subject compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
  • Proximity of fibrotic tissue directly adjacent to bone
  • Face/neck areas are excluded
  • Patients who, in the opinion of the investigator, would not be compliant with the schedule of study visits

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Pulsed Acoustic Cellular Expression therapy

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.

Primary outcome measure

  • Subcutaneous Fibrosis Mass [ Time Frame: One month ]

Central Contacts and Locations

Central contacts

Antoinette Nguyen

312-695-6022antoinette.nguyen@northwestern.edu

Locations

Lavin Pavilion Suite 2060

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Antoinette Nguyen

312-695-6022antoinette.nguyen@northwestern.edu

Principal Investigator:

Robert D. Galiano, MD, FACS

More Information

Sponsor

Northwestern University

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • breast fibrosis
  • postoperative fibrosis
  • shockwave therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-04-16.