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Procedure
Sensory Restoration Surgery for Breast Reconstruction
N/A
Recruiting
Led By Gedge D Rosson, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after diep flap breast reconstruction
Awards & highlights
Study Summary
This trial will help to determine if using the Avance® Nerve Graft during breast reconstruction surgery helps to improve the chances of restoring sensation in the skin overlying the reconstructed breast(s).
Who is the study for?
This trial is for women over 18 who are undergoing unilateral mastectomy and breast reconstruction using their own abdominal tissue (DIEP flap). They must understand the study and consent to participate. Excluded are pregnant or lactating women, those with previous reconstructions or lumpectomy with radiation, recurrent breast cancer, and conditions like diabetic neuropathy or severe peripheral neuropathy.Check my eligibility
What is being tested?
The trial tests sensory restoration in reconstructed breasts. Participants will be randomly assigned to receive DIEP flap reconstruction with neurotization using Avance® Nerve Graft (to connect nerves from abdomen to chest) or without neurotization. The goal is to see if sensation can be restored more effectively with the nerve graft.See study design
What are the potential side effects?
Potential side effects may include loss of sensation at the donor site, infection, neuroma formation (painful nerve growth), tingling, numbness, or burning sensations due to nerve repair procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after diep flap breast reconstruction
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after diep flap breast reconstruction
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12-month Breast sensation as assessed by the AcroValTM device
Secondary outcome measures
Breast sensation at 18 months as assessed by the AcroValTM device
Breast sensation at 24 months as assessed by the AcroValTM device
Breast sensation at 6 months as assessed by the AcroValTM device
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Neurotized PatientsExperimental Treatment1 Intervention
Neurotization will be performed at the time of reconstruction.
Group II: Non-Neurotized PatientsActive Control1 Intervention
No Neurotization will be performed at the time of reconstruction.
Find a Location
Who is running the clinical trial?
Axogen CorporationIndustry Sponsor
10 Previous Clinical Trials
5,432 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,262 Previous Clinical Trials
14,823,008 Total Patients Enrolled
1 Trials studying Breast Reconstruction
722 Patients Enrolled for Breast Reconstruction
Gedge D Rosson, MDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
58 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have conditions like diabetic neuropathy, thyroid disorders, or severe nerve damage from other causes.I am 18 years old or older.I am planning to have a mastectomy and DIEP flap reconstruction at Johns Hopkins.I will be assigned to one of two breast reconstruction methods, with or without nerve connection.I have not had breast reconstruction or lumpectomy with radiation before.My reconstruction uses my tissue, and the flap is not exposed.My breast cancer has not come back after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Neurotized Patients
- Group 2: Non-Neurotized Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor currently accepting participants?
"This clinical investigation is currently looking for volunteers, according to the data hosted on clinicaltrials.gov. This research endeavor was first posted online in December 2020 and recently updated at the conclusion of 2021."
Answered by AI
How many individuals are actively participating in this therapeutic research?
"Yes, the details made available on clinicaltrials.gov confirm that this medical study, first posted on December 1st 2020, is actively recruiting participants. The researchers are looking to enroll 156 patients across one site."
Answered by AI
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