Shockwaves aim to soften Post-Surgery breast scars
NCT ID NCT06919042
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a device that delivers targeted sound waves (shockwave therapy) can reduce hard scar tissue that sometimes forms after breast surgery. Researchers will enroll 100 adults who have firmness in their breast tissue after plastic surgery. They will measure changes in scar size and pain over time. The goal is to find a non-invasive way to improve recovery and comfort.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pulsed Acoustic Cellular Expression therapy (shockwave device)
- What this could lead to
- If it works, this could offer a non-invasive way to reduce scar tissue and pain after breast surgery.
- What could go wrong
- This is an early, single-center study with no control group, so results may not be conclusive. The therapy might not reduce fibrosis or could cause discomfort.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lavin Pavilion Suite 2060
RECRUITINGChicago, Illinois, 60611, United States