Implant Based Breast ReconstructionTIGR-MatrixNCT06511167
Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
An observational study of Implant Based Breast Reconstruction, run by AWOgyn at 5 sites in Germany.
Trial summary
The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire. The study also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Implant Based Breast Reconstruction
- What is being tested?
- TIGR® Matrix
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 5 sitesGermany
- Study dates
- 8 Nov 2024to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who will undergo breast prepectoral implant-based breast reconstructive surgery
Who may be able to join
- Women with histologically confirmed breast cancer or precancerosis or genetic pre- existing conditions with increased risk of breast cancer or with a family history all with an indication for skin sparing or nipple sparing mastectomy (SSM or NSM); or women with indication of prophylactic operation
- The health of women must comply with ECOG performance status 0-2
- The decision for the implementation of the TIGR® Matrix was made before and independently from study enrollment
- Participant is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
- Patient information has been handed out and subject signed informed consent
- Participant has attained full age of 18 years
Who cannot join
- Pregnancy or breast-feeding patients
- Known intolerance to the material, mesh-implants under investigation
- Metastatic breast cancer (with a life expectancy < 5 years)
- Medicinal dis-regulated diabetes
- Inadequate bone marrow function with neutrophil granulocytes<1500 and blood plates < 100.000/µl
- Lack or withdrawn of written patients informed consent
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- Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol
- Participant is institutionalized by court or official order (MPDG §27)
- Participation in another surgical clinical investigation that influence the surgical technique or outcome.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Germany5 sites, 4 recruiting
- Recruiting
Agaplesion Markus Krankenhaus Frankfurt
Frankfurt am Main, Hesse, 60431
Katharina Kelling, Dr. med., +49 69 95 33 66 754, katharina.kelling@agaplesion.de
Katharina Kelling, Dr. med.
- Recruiting
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, 06110
Tilmann Lantzsch, Dr. med., +49 345 213 4341, t.lantzsch@krankenhaus-halle-saale.de
Tilmann Lantzsch, Dr. med.
- Recruiting
Klinik und Poliklinik für Frauenheilkunde Technische Universität München
München, Bavaria, 80337
Evelyn Klein, Dr. med., +49 89 41402433, evelyn.klein@tum.de
Evelyn Klein, Dr. med.
- Active, not recruiting
GRN-Klinik Weinheim
Weinheim, Baden-Wurttemberg, 69469
- Recruiting
Evangelisches Krankenhaus Wesel
Wesel, North Rhine-Westphalia, 46485
Daniela Rezek, Dr. med., +49 281 106 2324, daniela.rezek@evkwesel.de
Daniela Rezek, Dr. med.
About this study
Official title: National, Prospective, Multicentre Post Market Surveillance Study on "Patient Reported Outcome" of Implant Based Primary or Secondary Reconstructive Breast Surgery After Mastectomy Using the Complete Resorbable Synthetic TIGR® Matrix
The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire. The study also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective.
Read the detailed description
This national, multicentre, prospective, non-randomized post market surveillance clinical device investigation will be performed to obtain information on the resorbable surgical mesh TIGR® Matrix used during an implant-based breast surgery. Data will be collected on the participants' quality of life as well as on the rate of complications of the device under investigation.
- Conditions
- Implant Based Breast Reconstruction
- Being tested
- TIGR® Matrix
- Keywords
- TIGR® Matrix, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIGR® MatrixDevice
bioresorbable, synthetic, surgical mesh
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life 12 months after surgery (BREAST-Q)
Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities
Measured: 12 months after surgery
Secondary outcomes (7)
Quality of Life 6, 24, 36 months after surgery (BREAST-Q)
Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities
Measured: 6, 24, 36 months after surgery
Complication rate
The number and rate of occurrence of major complications, minor complications; Serious Adverse Events (SAEs) and Adverse Events (AEs)
Measured: minimum of 3 years and a maximum of 5 years after surgery
Complication rate of specific complications
Complication rate of:
- Seroma-Volume (Sum of fluid-volume during the drainage-time)
- Need for aspiration in symptomatic patients, number of aspirations in postoperative follow up
- Reconstructive failure (defined as unplanned implant loss)
Measured: minimum of 3 years and a maximum of 5 years after surgery
Days with drain(s)
The number of days between placement of drain system and removal of the drain
Measured: during hospital stay after surgery
Days of hospital stay
The number of days the participant spend in hospital after surgery
Measured: surgery to discharge from hospital
Cosmetic outcome
Domains of cosmesis of BREAST-Q as perceived by the participant as well as perceived by the physician
Measured: 6, 12, 24 ,36 month after surgery
Rate of unplanned conversion operations
Rate of unplanned conversion operations (to mastectomy without reconstruction; to mastectomy with reconstruction; to autologous reconstruction)
Measured: minimum of 3 years and a maximum of 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start8 Nov 2024
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Based Breast ReconstructionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AWOgyn
- Sponsor type
- University, hospital or other
- Collaborators
- Esculape GmbH
- Responsible party
- Sponsor
- Investigators
- Marc Thill, Prof., Study chair, AWOgyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511167
- Sponsor's protocol ID
- AWO-001
- Acronym
- TIGR-Matrix
- Status last verified
- May 2026
- First submitted
- 16 Jul 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Prospective, Multicentre Post Market Surveillance Study on "Patient Reported Outcome" of Implant Based Primary or Secondary Reconstructive Breast Surgery After Mastectomy Using the Complete Resorbable Synthetic TIGR® Matrix
- ClinicalTrials.gov ID
- NCT06511167
- Acronym / sponsor ID
- TIGR-Matrix / AWO-001
- Conditions
- Implant Based Breast Reconstruction
- Keywords
- TIGR® Matrix, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- AWOgynUniversity, hospital or other
- Collaborators
- Esculape GmbH
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire. The study also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective.
Detailed description
This national, multicentre, prospective, non-randomized post market surveillance clinical device investigation will be performed to obtain information on the resorbable surgical mesh TIGR® Matrix used during an implant-based breast surgery. Data will be collected on the participants' quality of life as well as on the rate of complications of the device under investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who will undergo breast prepectoral implant-based breast reconstructive surgery
Key inclusion criteria (6 listed)
- Women with histologically confirmed breast cancer or precancerosis or genetic pre- existing conditions with increased risk of breast cancer or with a family history all with an indication for skin sparing or nipple sparing mastectomy (SSM or NSM); or women with indication of prophylactic operation
- The health of women must comply with ECOG performance status 0-2
- The decision for the implementation of the TIGR® Matrix was made before and independently from study enrollment
- Participant is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
- Patient information has been handed out and subject signed informed consent
Key exclusion criteria (9 listed)
- Pregnancy or breast-feeding patients
- Known intolerance to the material, mesh-implants under investigation
- Metastatic breast cancer (with a life expectancy < 5 years)
- Medicinal dis-regulated diabetes
- Inadequate bone marrow function with neutrophil granulocytes<1500 and blood plates < 100.000/µl
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 |
|---|---|---|
| TIGR® Matrixbioresorbable, synthetic, surgical mesh | Device | – |
Primary outcome
Quality of Life 12 months after surgery (BREAST-Q)
Time frame: 12 months after surgery
Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities
7 secondary outcomes
Quality of Life 6, 24, 36 months after surgery (BREAST-Q)
Time frame: 6, 24, 36 months after surgery
Complication rate
Time frame: minimum of 3 years and a maximum of 5 years after surgery
Complication rate of specific complications
Time frame: minimum of 3 years and a maximum of 5 years after surgery
Days with drain(s)
Time frame: during hospital stay after surgery
Days of hospital stay
Time frame: surgery to discharge from hospital
Cosmetic outcome
Time frame: 6, 12, 24 ,36 month after surgery
Rate of unplanned conversion operations
Time frame: minimum of 3 years and a maximum of 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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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.
Marc Thill, Prof. study chair
AWOgyn
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implant Based Breast Reconstruction, run by AWOgyn at 5 sites in Germany.
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Thill, Prof. (+49 69 95 33 22 28, Marc.Thill@agaplesion.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life 12 months after surgery (BREAST-Q) (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.