Regenerative High Purity Type I Collagen Scaffold for Breast Volume Restoration Following Breast-Conserving Surgery: A Multicentre Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Volume restoration
研究概览
简要总结
This clinical trial evaluates the safety and efficacy of High Purity Type I Collagen scaffold for breast volume restoration following breast-conserving surgery (BCS). The regenerative collagen matrix serves as a biocompatible scaffold promoting tissue ingrowth, neovascularization, and gradual remodeling, thereby improving cosmetic outcomes and patient quality of life after partial mastectomy.
详细描述
Breast-conserving surgery (BCS) is the standard treatment for early-stage breast cancer, balancing oncological safety with aesthetic preservation. However, postoperative volume defects may cause breast asymmetry and psychological distress. Traditional options such as flaps or implants are limited by donor-site morbidity and complications.
This prospective, single-arm, bi-centre study investigates the clinical performance of a high-purity, cross-linked bovine Type I collagen scaffold for immediate breast volume restoration. The study will assess safety, volume maintenance, cosmetic appearance, and patient-reported outcomes through standardized 3D imaging, MRI analysis, and validated quality-of-life instruments.
The study will enroll 40 women undergoing BCS with expected volume defects ≥20%, with 2-month postoperative follow-up for primary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18-70 years
- •Histologically confirmed breast carcinoma (Stage 0-II) or high-risk lesions requiring excision
- •Expected postoperative defect ≥20% of total breast volume
- •ECOG 0-1, adequate organ function
- •Informed consent provided, compliant with follow-up schedule
排除标准
- •Prior breast surgery or radiotherapy to affected breast
- •Locally advanced or inflammatory carcinoma
- •Collagen hypersensitivity or autoimmune disease
- •Active infection, pregnancy, lactation, or smoking within 6 weeks
- •Concurrent participation in other clinical studies
研究组 & 干预措施
High Purity Type I Collagen Scaffold
Patients undergoing breast conservative surgery will receive immediate placement of high purity Type I collagen scaffold to fill tissue defect. The scaffold is a sterile, cross-linked bovine Type I collagen matrix with degradation time of 2 months, sterilized by ethylene oxide
干预措施: High Purity Type I Collagen Scaffold (Regenerative Matrix) (Device)
结局指标
主要结局
Volume restoration
时间窗: 2 months post-operative
Proportion of patients achieving ≥80% breast volume retention at 2 months assessed by imaging/MRI
Patient satisfaction with breast volume restoration
时间窗: 2 months post-operative
Patient satisfaction ≥7/10 on standardized satisfaction scale (BREAST-Q). The BREAST-Q is a validated patient-reported outcome measure (PROM) used to assess the quality of life and satisfaction of patients undergoing breast surgery. It consists of specific modules for different procedures, like reconstruction, and measures aspects such as psychological well-being, physical well-being (chest and sexual), and satisfaction with the breasts and care. The scale, which results in scores from 0 to 100, helps evaluate the impact of surgery from the patient's perspective. Scores range from 0 to 100, with higher scores indicating a greater degree of health-related quality of life or satisfaction.
次要结局
- Breast Volume symmetry index(2 months post-operative)
- Objective Volume Assessment(2 months post-operative)
- Complications(2 months)
- Cosmetic Assessment(2 months post-operative)
- Radiological Outcomes(2 months)
- Pain Assessment(2 months)