CompletedNot Applicable

Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision

India40 participantsStarted 2025-10-15

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Volume Restoration

Timeframe: 2 months post-operative

Patient Satisfaction With Breast Volume Restoration

Timeframe: 4 weeks and 8 weeks post-operative

Trial details

NCT IDNCT07219316

SponsorAdichunchanagiri Institute of Medical Sciences, B G Nagara

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-15

Results submitted2026-03-05

View on ClinicalTrials.gov More Breast-Conserving Surgery trials