A Prospective, Multicenter, Controlled Clinical Study of 3D-printed Biodegradable Breast Implants for Breast Restoration

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction and the quality of life of patients, with traditional breast-conserving surgery and traditional breast reconstruction as controls. It will also explore the safety of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction. The main question it aims to answer is: Can breast cancer patients who are not suitable for breast-conserving surgery use 3D-printed biodegradable material breast implants for breast reconstruction? Do patients who undergo breast reconstruction based on 3D-printed biodegradable material breast implants have advantages over those who receive breast-conserving surgery or traditional silicone prosthesis breast reconstruction surgery in terms of cosmetic effects, quality of life and safety? What medical problems may occur when participants use 3D-printed biodegradable material-based breast implants for breast reconstruction? Participants will: Non-random enrollment. In the experimental group, breast reduction surgery based on 3D-printed degradable biological implants was received; In control group 1, traditional breast-conserving surgery was received; Traditional silicone prosthesis breast reconstruction was received in control Group 2.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Female patients with newly diagnosed primary breast cancer, aged 18 to 70 years, confirmed by histopathology.

• Willing to undergo breast-conserving surgery, concurrent silicone prosthesis breast reconstruction, or breast reconstruction with 3D-printed biodegradable material breast implants.

• Having indications for subcutaneous glandectomy that preserves the nipples and areolas.

• ECOG performance status score: 0-1.

• If receiving neoadjuvant chemotherapy, the interval between chemotherapy completion and surgery is less than 8 weeks.

• Good compliance with the planned treatment, ability to understand the study procedures, and willingness to sign the written informed consent form.

Locations
Other Locations
China
Xijing hospital
RECRUITING
Xi'an
Contact Information
Primary
Ju liang J L Zhang
vascularzhang@163.com
029-84775271
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Breast restoration surgery based on 3D printed degradable biological implants
The patient will undergo breast reduction surgery based on 3D-printed degradable biological implants
Active_comparator: Traditional breast-conserving surgery
The patient will undergo traditional breast-conserving surgery
Active_comparator: Traditional silicone prosthesis breast reconstruction
The patient will undergo traditional silicone prosthesis breast reconstruction
Related Therapeutic Areas
Sponsors
Leads: Xijing Hospital

This content was sourced from clinicaltrials.gov

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