Using shockwave therapy to treat breast reconstruction fibrosis
Official title: A Prospective Single-center Study for Evaluation of the Effectiveness of Pulsed Acoustic Cellular Expression Technology on Post-Operative Soft Tissue Fibrosis.
Run by Northwestern University · NCT06919042 · Data updated 2026-11-12
This study tests whether shockwave therapy can help women with breast reconstruction reduce scarring and improve their recovery after surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | May 2026 |
| Study ends | September 2026 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT06919042 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult females who have developed postoperative fibrosis following breast reconstruction surgery.
✕Probably not a fit
Patients with active infections, systemic illnesses, or those who are pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of extracorporeal shockwave therapy in reducing postoperative soft tissue fibrosis in women who have undergone breast reconstruction. It is a single-blind, randomized controlled trial where participants receive either active shockwave therapy or a sham treatment over eight sessions within four weeks. Follow-up evaluations are conducted three months post-treatment to assess outcomes. The study includes adult females with clinically diagnosed postoperative fibrosis and excludes those with certain medical conditions or prior treatments that may interfere with results.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life for patients suffering from postoperative breast reconstruction fibrosis.
How similar studies have gone: While this approach is relatively novel, similar studies using shockwave therapy for other types of fibrosis have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Lavin Pavilion Suite 2060
Chicago, Illinois, United States Recruiting
Study contacts
- Study coordinator: Antoinette Nguyen
- Email: antoinette.nguyen@northwestern.edu
- Phone: 312-695-6022
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.