Breast-Conserving SurgeryNCT07219316

Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision

A study testing High Purity Type I Collagen Scaffold (Regenerative Matrix) in people with Breast-Conserving Surgery, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 2 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Breast-Conserving Surgery
What is being tested?: High Purity Type I Collagen Scaffold (Regenerative Matrix)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesIndia
Study dates: 15 Oct 2025to 25 Feb 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

India2 sites

Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448
JSS Medical College Hospital
Mysore, Karnataka, 570004

Other trials in India

About this study

Official title: Regenerative High Purity Type I Collagen Scaffold for Breast Cancer Excision Repair and Reconstruction: A Prospective Multicenter Clinical Trial

Read the 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 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.

Conditions: Breast-Conserving Surgery
Being tested: High Purity Type I Collagen Scaffold (Regenerative Matrix)
Keywords: Breast-Conserving Surgery, Volume Restoration, Collagen Matrix, Breast Reconstruction, Regenerative Scaffold, High Purity Type I Collagen, Oncoplastic Surgery, Surgicoll-Mesh

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Purity Type I Collagen Scaffold (Regenerative Matrix)Device
Standard breast-conserving surgery followed by immediate scaffold placement into the excision cavity. The scaffold is sutured using absorbable sutures and covered with standard wound closure. Postoperative care follows institutional protocols. Adjuvant radiotherapy and chemotherapy as indicated per oncological protocols; standard antibiotics and analgesics.

Study groups in NCT07219316
Study group	Role	What they receive
High Purity Type I Collagen Scaffold	Experimental	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 Receives: Device: High Purity Type I Collagen Scaffold (Regenerative Matrix)

What is being measured

The primary outcome is the main question the study is designed to answer.

Volume Restoration
Proportion of patients achieving ≥80% breast volume retention at 2 months assessed by imaging/MRI
Measured: 2 months post-operative
Patient Satisfaction With Breast Volume Restoration
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.
Measured: 4 weeks and 8 weeks post-operative

Secondary outcomes (4)

Objective Volume Assessment
Percentage change in breast volume at 2, 4, and 8 weeks post-surgery
Measured: 2 weeks, 4 weeks, and 8 weeks post-operative
Cosmetic Assessment
Physician-rated 4-point cosmetic score. This is a standardized visual assessment tool used to evaluate the aesthetic outcome of the operated breast compared to the contralateral breast. The assessment is based on parameters such as breast shape, volume, symmetry, contour, nipple-areolar complex position, and scar appearance. The 4-point grading system is typically defined as:
Grade 4 - Excellent - Described as operated breast almost identical to contralateral side - Criteria is minimal asymmetry, natural contour Grade 3 - Good - Described as slight difference in shape or volume - Acceptable symmetry and cosmetic result Grade 2 - Fair - Described as noticeable asymmetry or distortion - Moderate contour irregularity or scar visibility Grade 1 - Poor - Described as significant deformity or volume loss - Unacceptable cosmetic result
Measured: 2 months post-operative
Radiological Outcomes
MRI Scoring System - Scaffold Integration, Vascularization \& Resorption:
Standardized MRI assessment of scaffold performance (integration, neovascularization, resorption) at baseline, Week 4, and Week 8.
MRI protocol:
T1 (axial/sagittal), T2/STIR (axial), DCE T1 (pre-contrast, early 30-60 s, intermediate 90-120 s, delayed 4-6 min),
Scores (0-3 each):
1. Integration: 0 = none; 1 = minimal; 2 = moderate; 3 = complete tissue continuity.
2. Vascularization: 0 = none; 1 = mild/delayed; 2 = moderate (neovascular); 3 = marked (early enhancement).
3. Resorption: 0 > 75% residual; 1 = 50-75%; 2 = 25-50%; 3 < 25% residual. D. Tissue Quality: 0 = fluid-filled; 1 = mostly fluid; 2 = mixed; 3 = tissue-like.
Composite MRI Integration Score (MIS 0-12): Higher = better integration/remodeling.
Interpretation:
0-3 Poor, 4-7 Moderate, 8-10 Good, 11-12 Excellent.
Measured: Immediate postoperative, 4 weeks, and 8 weeks
Number of Participants With Postoperative Complications
Number of participants experiencing postoperative complications within the 2-month follow-up period after breast cancer excision and collagen scaffold implantation. Complications assessed include seroma, hematoma, surgical site infection, abscess, wound dehiscence, scaffold exposure or extrusion, prolonged postoperative pain, and ecchymosis.
Each participant is counted once per complication category. Higher values indicate greater frequency of complications.
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202525 Feb 2026

First posted21 Oct 2025
Study start15 Oct 2025
Primary completion15 Feb 2026
Study completion25 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Breast-Conserving SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07219316
Sponsor's protocol ID: AIMS/IEC/240/2025
Status last verified: Mar 2026
First submitted: 17 Oct 2025
Last updated: 27 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: De-identified datasets will be available upon reasonable request following publication of primary results.

Publications

Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.
PubMed 40747200
Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.
PubMed 39649230
van Loevezijn AA, Geluk CS, van den Berg MJ, van Werkhoven ED, Vrancken Peeters MTFD, van Duijnhoven FH, Hoornweg MJ. Immediate or delayed oncoplastic surgery after breast conserving surgery at the Netherlands Cancer Institute: a cohort study of 251 cases. Breast Cancer Res Treat. 2023 Apr;198(2):295-307. doi: 10.1007/s10549-022-06841-8. Epub 2023 Jan 24.
PubMed 36690822
Slavin SA, Halperin T. Reconstruction of the breast conservation deformity. Semin Plast Surg. 2004 May;18(2):89-96. doi: 10.1055/s-2004-829043.
PubMed 20574487
Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug.
PubMed 40862036

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery
Breast Cancer
RecruitingObservational study
Scarless Advanced Breast Extended Oncoplasty: The ScarABEO Study
Breast Cancer, Oncoplastic Breast Surgery
Active, not recruitingPhase 3
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer
Breast Cancer
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
Not yet recruitingPhase 2
Adding Preoperative Radiotherapy Based on Early Treatment Response in Breast Cancer
Invasive Breast Cancer

All Breast-Conserving Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Regenerative High Purity Type I Collagen Scaffold for Breast Cancer Excision Repair and Reconstruction: A Prospective Multicenter Clinical Trial
ClinicalTrials.gov ID: NCT07219316
Acronym / sponsor ID: AIMS/IEC/240/2025
Conditions: Breast-Conserving Surgery
Keywords: Breast-Conserving Surgery, Volume Restoration, Collagen Matrix, Breast Reconstruction, Regenerative Scaffold, High Purity Type I Collagen, Oncoplastic Surgery, Surgicoll-Mesh
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Adichunchanagiri Institute of Medical Sciences, B G NagaraUniversity, hospital or other
Study start: 15 Oct 2025 (actual)
Primary completion: 15 Feb 2026 (actual)
Study completion: 25 Feb 2026 (actual)
First posted: 21 Oct 2025 (actual)
Results: Posted 27 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will enroll 40 women undergoing BCS with expected volume defects ≥20%, with 2-month postoperative follow-up for primary endpoints.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
High Purity Type I Collagen Scaffold	Experimental	Device: High Purity Type I Collagen Scaffold (Regenerative Matrix)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

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High Purity Type I Collagen Scaffold (Regenerative Matrix)Standard breast-conserving surgery followed by immediate scaffold placement into the excision cavity. The scaffold is sutured using absorbable sutures and covered with standard wound closure. Postoperative care follows institutional protocols. Adjuvant radiotherapy and chemotherapy as indicated per oncological protocols; standard antibiotics and analgesics.	Device	High Purity Type I Collagen Scaffold

Primary outcome

Volume Restoration
Time frame: 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
Time frame: 4 weeks and 8 weeks 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.

4 secondary outcomes

Objective Volume Assessment
Time frame: 2 weeks, 4 weeks, and 8 weeks post-operative
Cosmetic Assessment
Time frame: 2 months post-operative
Radiological Outcomes
Time frame: Immediate postoperative, 4 weeks, and 8 weeks
Number of Participants With Postoperative Complications
Time frame: 2 months

Results and safety

Results posted to the registry on 27 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Purity Type I Collagen Scaffold	40	40

Primary outcome: Volume Restoration

Time frame: 2 months post-operative. Count of participants. Unit: Participants

Measure	High Purity Type I Collagen Scaffold n = 40
Value	33

Primary outcome: Patient Satisfaction With Breast Volume Restoration

Time frame: 4 weeks and 8 weeks post-operative. Mean (Standard Deviation). Unit: score on a scale

Measure	High Purity Type I Collagen Scaffold n = 40
4 weeks	72.5 (7.9)
8 weeks	78.9 (7.4)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Purity Type I Collagen Scaffold	0 of 40 (0%)	6 of 40 (15%)	0 of 40

Limitations and caveats (from the sponsor): Single-arm design without a concurrent control group limits causal inference and prevents direct statistical comparison with alternative reconstruction techniques Short follow-up duration Study population was relatively homogeneous, consisting of women with early-stage disease (stage 0-II)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 40747200Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.
Background: PubMed 39649230Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.
Background: PubMed 36690822van Loevezijn AA, Geluk CS, van den Berg MJ, van Werkhoven ED, Vrancken Peeters MTFD, van Duijnhoven FH, Hoornweg MJ. Immediate or delayed oncoplastic surgery after breast conserving surgery at the Netherlands Cancer Institute: a cohort study of 251 cases. Breast Cancer Res Treat. 2023 Apr;198(2):295-307. doi: 10.1007/s10549-022-06841-8. Epub 2023 Jan 24.
Background: PubMed 20574487Slavin SA, Halperin T. Reconstruction of the breast conservation deformity. Semin Plast Surg. 2004 May;18(2):89-96. doi: 10.1055/s-2004-829043.
Background: PubMed 40862036Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug.
Individual participant dataSharing planned: Yes. De-identified datasets will be available upon reasonable request following publication of primary results.

Related trials for Breast-Conserving Surgery

Recruiting
Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery
Breast Cancer
RecruitingObservational study
Scarless Advanced Breast Extended Oncoplasty: The ScarABEO Study
Breast Cancer, Oncoplastic Breast Surgery
Active, not recruitingPhase 3
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer
Breast Cancer
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
Not yet recruitingPhase 2
Adding Preoperative Radiotherapy Based on Early Treatment Response in Breast Cancer
Invasive Breast Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prema Dhanraj, MS, MCh study chair

Rajarajeswari Medical College and Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volume Restoration (time frame: 2 months post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07219316, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.