Neodyne Device for Cicatrix

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford University Medical Center, Stanford, CA
Cicatrix+1 More
Neodyne Device - Device
Eligibility
18+
Female
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Study Summary

Microsurgical breast reconstruction is most commonly performed with free abdominal flaps, which leave a long transverse lower abdominal scar. Due to tension across the incision, these scars frequently widen and hypertrophy. Hence, modalities that can reduce this tendency, thus, improving scar appearance are desirable. Here, we wish to investigate the impact of the Neodyne embrace device on postoperative abdominal scar appearance. The proposed study is novel in that it is the first RCT investigating the effect of the embrace device on scar appearance in the context of microsurgical breast reconstruction.

Eligible Conditions

  • Cicatrix
  • Breast Reconstruction

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 6 months

6 months
Scar Assessment

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Neodyne Device
1 of 1
Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Neodyne Device · No Placebo Group · N/A

Neodyne Device
Device
Experimental Group · 1 Intervention: Neodyne Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Trial Background

Arash Momeni, Principal Investigator
Principal Investigator
Stanford University
Closest Location: Stanford University Medical Center · Stanford, CA
2004First Recorded Clinical Trial
1 TrialsResearching Cicatrix
346 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female and have undergone breast reconstruction with free abdominal flaps.
The incision is aesthetically similar across the length of the incision.
You are able to provide written informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.