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Neodyne Device for Scar Improvement in Breast Reconstruction

N/A

Recruiting

Led By Arash Momeni, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18

Female Subjects who have undergone unilateral/bilateral microsurgical breast reconstruction with free abdominal flaps within approximately 1 week (4-8 days) prior to study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is investigating whether the Neodyne embrace device can improve the appearance of abdominal scars following microsurgical breast reconstruction.

Who is the study for?

This trial is for women over 18 who've had microsurgical breast reconstruction with abdominal flaps within the last week. They must have a similar scar appearance along the incision, be able to understand and consent to study requirements, and not currently smoke or have certain medical conditions like connective tissue diseases or significant recent weight loss.Check my eligibility

What is being tested?

The trial is testing the Neodyne embrace device's effectiveness on improving the appearance of abdominal scars after breast reconstruction surgery. It's a randomized controlled trial (RCT), which means participants are randomly assigned to receive either the embrace device treatment or no treatment for comparison.See study design

What are the potential side effects?

Potential side effects may include skin reactions related to sensitivity towards steri-strip tapes, medical tapes, or adhesives used in conjunction with the Neodyne embrace device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I had breast reconstruction with tissue from my abdomen about a week ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Scar Assessment

Trial Design

2Treatment groups

Experimental Treatment

Group I: Neodyne DeviceExperimental Treatment1 Intervention

After eligible patients have provided informed consent, the side of the abdomen to be treated with the Neodyne Device will be randomly selected by opening a sealed randomization envelope. The selected side will be treated with the Neodyne Device through the full study. The Neodyne Device will be applied to a portion of the abdominal incision by the health care provider at 1 week (4-8 days) after the procedure. The other portion of the abdominal incision (Arm Title: Control) will serve as the control and will be treated per the investigator's standard of care. Subjects will return to the Investigator's office for a total of 8 weeks for application and removal of the Neodyne Dressing.

Group II: ControlExperimental Treatment1 Intervention

See above

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,388 Previous Clinical Trials

17,334,316 Total Patients Enrolled

Arash Momeni, MDPrincipal InvestigatorStanford University

2 Previous Clinical Trials

136 Total Patients Enrolled

Media Library

Neodyne Device Clinical Trial Eligibility Overview. Trial Name: NCT05377723 — N/A

Scar Research Study Groups: Neodyne Device, Control

Scar Clinical Trial 2023: Neodyne Device Highlights & Side Effects. Trial Name: NCT05377723 — N/A

Neodyne Device 2023 Treatment Timeline for Medical Study. Trial Name: NCT05377723 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I join this clinical research program?

"In order to qualify for this clinical trial, applicants must possess cicatrix and be between the ages of 18-89. The team behind this study is looking to recruit about 100 participants."

Answered by AI

Are geriatric individuals eligible for enrollment in this trial?

"Participants must meet certain age requirements to be considered eligible for this clinical trial. The minimum accepted age is 18 while the upper limit caps at 89 years old."

Answered by AI

Is the research project currently open to new participants?

"Affirmative. The clinicaltrials.gov platform indicates that this medical trial is currently enrolling participants; the study was initially published on October 31st 2022 and recently modified on the same date. Approximately one hundred individuals are needed to be recruited from a single location."

Answered by AI

What is the participant capacity of this research endeavor?

"Yes, as per the data on clinicaltrials.gov, this medical trial is in need of recruits. This research project was first published on October 31st 2022 and has since been updated to reflect current needs; 100 participants are being sought from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Abdominal Scar Improvement in Microsurgical Breast Reconstruction

Arash Momeni 2022. "Abdominal Scar Improvement in Microsurgical Breast Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05377723.

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