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Electrical Stimulation for Post-Mastectomy Sensation Improvement

N/A
Waitlist Available
Research Sponsored by Ming Chan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Woman aged 18-60 undergoing bilateral, prophylactic nipple/skin-sparing mastectomy with immediate implant reconstruction
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will study whether electrical stimulation can help improve sensation in the reconstructed breast for women who have undergone prophylactic mastectomy.

Who is the study for?
This trial is for women aged 18-60 planning to have preventive mastectomy with immediate breast reconstruction due to a high risk of breast cancer. They must not have had previous breast surgeries, be current smokers, or suffer from preexisting nerve damage in the periphery of their body.Check my eligibility
What is being tested?
The study tests if electrical stimulation (ES) can improve sensation in breasts after reconstructive surgery. Half the participants will receive ES on one breast during surgery and sensation will be compared between both breasts at several intervals up to two years post-surgery.See study design
What are the potential side effects?
While specific side effects are not listed, electrical stimulation is generally considered safe but may include temporary discomfort at the site of application or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 18-60 planning a preventive double mastectomy with immediate implant reconstruction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Sensation
Secondary outcome measures
Patient Satisfaction

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Electrical Stimulation BreastExperimental Treatment1 Intervention
Breast that will receive 1 hour of intraoperative electrical stimulation
Group II: No Electrical Stimulation BreastPlacebo Group1 Intervention
The contralateral breast of the patient will receive no electrical stimulation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electrical Stimulation
2013
Completed Phase 2
~400

Find a Location

Who is running the clinical trial?

Ming ChanLead Sponsor
1 Previous Clinical Trials
66 Total Patients Enrolled
University of AlbertaLead Sponsor
883 Previous Clinical Trials
393,179 Total Patients Enrolled

Media Library

Electrical Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT03240900 — N/A
Breast Reduction Surgery Research Study Groups: No Electrical Stimulation Breast, Electrical Stimulation Breast
Breast Reduction Surgery Clinical Trial 2023: Electrical Stimulation Highlights & Side Effects. Trial Name: NCT03240900 — N/A
Electrical Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03240900 — N/A

Frequently Asked Questions

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

Are there any opportunities for eligible participants to join the trial?

"It appears that, according to clinicaltrials.gov's records, this medical trial is not presently recruiting patients; its initial posting was on July 1st 2023 and the most recent update occurred on May 27th 2022. However, there are 5 other trials in need of participants at present."

Answered by AI

Am I eligible to enroll in this research project?

"The qualifications for this medical trial are straightforward: candidates must have undergone mammaplasty and be aged between 18 to 60. Participants required total a modest 30 people."

Answered by AI

Does the experimental protocol include individuals in their eighties?

"As per the outlined requirements for participation, adults who are between 18 and 60 years old can join this clinical trial."

Answered by AI

Who else is applying?

What site did they apply to?
University of Alberta Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Please i want try be in this trial i have breast cancer her 2 positive, Estrogen negativeplease help me , lett me know thank you.
PatientReceived 1 prior treatment
Recent research and studies
~20 spots leftby Nov 2025