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Search / Trial NCT05975372

Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction

Launched by STANFORD UNIVERSITY · Jul 27, 2023

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

Implant Based Breast Reconstruction Tissue Expansion

ClinConnect Summary

This clinical trial is studying a new device called the Blossom Smart Expander, which is designed to make breast reconstruction easier and more comfortable for women. Traditionally, women who undergo breast reconstruction with tissue expanders need to visit the doctor's office regularly for saline injections to help stretch the skin, which can be uncomfortable. The Blossom Smart Expander aims to replace these frequent injections with a device that slowly and continuously adds a small amount of saline on its own, making the process less invasive and more tailored to each patient’s needs.

To be eligible for this study, participants need to be women aged 18 or older who are looking for breast reconstruction or enhancement, and they should be able to read and understand the consent forms in English. However, women with active breast cancer, certain medical conditions, or those who are pregnant or nursing will not be included in the study. If you participate, you can expect to help researchers understand how well this new device works compared to traditional methods. This trial is not yet recruiting participants, so there will be more information available once it begins.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Women ages 18 or older; pursuing non-oncologic breast reconstruction or augmentation; and ability to understand and the willingness to sign a written informed consent document (english language). Only patients desiring 2-staged tissue expander/ implant-based breast reconstruction will be approached for potential enrollment in the study.
  • Exclusion Criteria:
  • Patients with active breast cancer; recent steroid use; major medical comorbidities (defined as ASA III or greater); a connective tissue disorder; are pregnant or nursing; are unable to understand and sign the english language consent forms; or age over 65 years, will be excluded from the study.

About Stanford University

Stanford University is a prestigious academic institution renowned for its cutting-edge research and innovation in healthcare and medicine. As a clinical trial sponsor, Stanford leverages its extensive resources, including a collaborative network of world-class researchers and state-of-the-art facilities, to advance medical knowledge and improve patient care. The university is committed to conducting rigorous, ethical research that adheres to the highest standards of scientific integrity, fostering an environment where groundbreaking discoveries can translate into effective clinical applications. Through its clinical trials, Stanford aims to address critical health challenges and contribute to the development of novel therapies and treatment strategies.

Locations

Palo Alto, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported