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Shockwave Therapy for Post-Breast Reconstruction Fibrosis

This study is looking at whether a treatment called Pulsed Acoustic Cellular Expression therapy (a device that uses targeted sound waves) can help reduce fibrosis (scar tissue) after breast reconstruction surgery. The therapy works by encouraging beneficial changes in your cells, like improving blood vessel growth and reorganizing scar tissue. You might be able to join if you are an adult woman over 18 who has developed soft tissue firmness after plastic surgery, including breast reconstruction. The main goal is to see if this therapy can reduce the size of subcutaneous fibrosis (scar tissue under the skin) after one month. The study status is currently unclear, and it plans to enroll 100 participants.

Study design
This is a single-blind, randomized controlled trial. You would be randomly assigned to receive either the active shockwave therapy or a sham (placebo) version, and you wouldn't know which one you're getting.
What's involved
You would receive eight treatment sessions over four weeks, with two sessions per week. You would also have a follow-up evaluation at three months.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for evaluation at three months after the intervention period.

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NCT06919042

Shockwave in Postoperative Breast Reconstruction Fibrosis

Recruiting
NAAges 18+InterventionalTreatment
Northwestern University
~100 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:Pulsed Acoustic Cellular Expression therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Subcutaneous Fibrosis Mass
Measured over One month

Conditions

Fibrosis Breast

Explore related trials

Fibrosis

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Antoinette Nguyen
[email protected]
312-695-6022
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Subcutaneous Fibrosis MassOne month

    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.