Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision (NCT07219316) | Clinical Trial Compass
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 range
18 Years – 70 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Volume Restoration
Timeframe: 2 months post-operative
2
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