Autologous Nerve Graft Breast Reconstruction Neurotization

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 20 years and older
• Women only
• No healthy volunteers
• Adult, Older adult

Study population: Patients undergoing nipple-sparing mastectomy and immediate breast reconstruction

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Breast Neurotization During Breast Reconstruction Enhances Quality of Life

Conditions

Breast Reconstruction, Breast Cancer Patients, Nipple-sparing Mastectomy

Being tested

Breast reconstruction with neurotization, Breast reconstruction without neurotization

Keywords

breast reconstruction, nipple-sparing mastectomy, breast neurotization, quality of life, autologous nerve graft, nipple sensation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Breast reconstruction with neurotizationProcedure or surgery

  Patients received breast reconstruction with neurotization procedure

• Breast reconstruction without neurotizationProcedure or surgery

  Patients received breast reconstruction without neurotization

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Pre-operative Quality of life

   Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms

   Measured: Before breast reconstructive surgery

2. Post-operative-two-year Quality of life

   Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms

   Measured: Two-year after breast reconstructive surgery

3. Post-operative-one-year Quality of life

   Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms

   Measured: One-year after breast reconstructive surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted8 Oct 2024
2. Study start29 Nov 2021
3. Primary completion31 Dec 2026 (estimated)
4. Study completion31 Dec 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Breast ReconstructionStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.