Status:
RECRUITING
Regenerative Collagen Scaffold for Breast Volume Restoration in Breast-Conserving Surgery
Lead Sponsor:
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Conditions:
Breast-Conserving Surgery
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 breas...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07219316
Start Date
October 15 2025
End Date
March 1 2026
Last Update
October 21 2025
Active Locations (2)
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1
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, India, 571448
2
JSS Medical College Hospital
Mysore, Karnataka, India, 570004