RecruitingNot ApplicableNCT06919042

Shockwave in Postoperative Breast Reconstruction Fibrosis

A Prospective Single-center Study for Evaluation of the Effectiveness of Pulsed Acoustic Cellular Expression Technology on Post-Operative Soft Tissue Fibrosis.


Sponsor

Northwestern University

Enrollment

100 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • 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 Criteria5

  • 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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Interventions

DEVICEPulsed 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.


Locations(1)

Lavin Pavilion Suite 2060

Chicago, Illinois, United States

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NCT06919042


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