Shockwave in Postoperative Breast Reconstruction Fibrosis

NCT06919042 | Recruiting FDA Device

• 1 other identifier: STU00221726
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibrosis Breast

Keywords

breast fibrosis; postoperative fibrosis; shockwave therapy

Outcome Measures

Primary Outcomes (1)

• Subcutaneous Fibrosis Mass

  Change in size of subcutaneous fibrosis mass assess clinically by PI, point-of-care ultrasound, caliper measurements, and objective/subjective measures by an observer and the patient. Score values range from 1 to 10 with a higher score indicating a worse outcome.

  One month

Secondary Outcomes (2)

• Pain Score

  One month

• Adverse Events

  Three months

Study Arms (2)

Control

NO INTERVENTION

The control arm receives eight sessions of a sham (placebo) version of the therapy.

Intervention

EXPERIMENTAL

The intervention arm receives eight sessions of Pulsed Acoustic Cellular Expression (PACE) therapy delivered twice weekly for four weeks at level E2

Device: Pulsed Acoustic Cellular Expression therapy

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Lavin Pavilion Suite 2060

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (1)

• Nguyen AT, Chon J, Li RA, Melnick BA, Abu-Romman A, Laiwalla R, Adam TH, Galiano RD. Extracorporeal shockwave therapy improves post-breast reconstruction fibrosis: A randomized controlled blinded clinical trial. J Plast Reconstr Aesthet Surg. 2025 Nov;110:7-17. doi: 10.1016/j.bjps.2025.08.045. Epub 2025 Sep 9.

  PMID: 41038043 DERIVED

Central Study Contacts

Antoinette Nguyen

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: October 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)