N/A
N=40
Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision
Breast-Conserving Surgery
Bottom Line
View on ClinicalTrials.gov: NCT07219316 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Volume Restoration — 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Purity Type I Collagen Scaffold (Regenerative Matrix) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
- Primary completion
- Feb 2026
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume Restoration |
33 | — |
| PRIMARY Patient Satisfaction With Breast Volume Restoration |
72.5; 78.9 | — |
| SECONDARY Objective Volume Assessment |
92.4; 90.1; 88.6 | — |
| SECONDARY Cosmetic Assessment |
22; 14; 4; 0 | — |
| SECONDARY Radiological Outcomes |
3.2; 6.8; 9.1 | — |
| SECONDARY Number of Participants With Postoperative Complications |
4; 2; 6; 3 | — |
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 serves as a biocompatible scaffold promoting tissue ingrowth, neovascularization, and gradual remodeling, thereby improving cosmetic outcomes and patient quality of life after partial mastectomy.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT07219316). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.