Status:
RECRUITING
Shockwave in Postoperative Breast Reconstruction Fibrosis
Lead Sponsor:
Northwestern University
Conditions:
Fibrosis Breast
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study evaluates the potential for extracorporeal shockwave therapy to reduce post-operative soft tissue fibrosis.
Detailed Description
This study was conducted as a single-blind, randomized controlled trial (RCT) to evaluate the efficacy of acoustic shockwave therapy in treating post-surgical fibrosis following breast reconstruction....
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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06919042
Start Date
October 1 2024
End Date
September 1 2026
Last Update
April 9 2025
Active Locations (1)
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1
Lavin Pavilion Suite 2060
Chicago, Illinois, United States, 60611