Breast CancerNCT04967976
Breast Mesh Used in Two-staged Breast Reconstruction
A study testing TiLoop Bra mesh in expander-implant breast reconstrution and sub-pectoral expander-implant breast reconstruction in people with Breast Cancer and Radiation, run by Tianjin Medical University Cancer Institute and Hospital at 6 sites in 3 countries.
Trial summary
This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Radiation, Breast Reconstruction
- What is being tested?
- TiLoop Bra mesh in expander-implant breast reconstrution and sub-pectoral expander-implant breast reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Aug 2021to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosed with breast cancer
- More than 18 years old
- Karnofsky Performance Status (KPS) larger than 80
- No clinical or imaging evidence of distant metastasis
- BMI < 35kg/m2
- Patients with no or mild breast ptosis
Show all 9Show fewer
- No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
- Mental Health Patient
- -
Who cannot join
- 1. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion
- -
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
China4 sites, 4 recruiting
- Recruiting
Jilin Cancer Hospital
Ch’ang-ch’un, Jilin
Guiying Xu
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Xuli Meng
- Recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu
Suisheng Yang
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Bowen Ding, 18822077799, ding_x87@126.com
Jian Yin
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Edward Chang
Germany1 site, 1 recruiting
- Recruiting
Technical University of Munich
Munich
Stefan Paepke
About this study
Official title: A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.
- Conditions
- Breast Cancer, Radiation, Breast Reconstruction, Synthetic Mesh
- Being tested
- TiLoop Bra mesh in expander-implant breast reconstrution, sub-pectoral expander-implant breast reconstruction
- Keywords
- breast cancer, breast reconstruction, radiation, synthetic mesh
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiLoop Bra mesh in expander-implant breast reconstrutionProcedure or surgery
The tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral.
sub-pectoral expander-implant breast reconstructionProcedure or surgery
The tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
| Study group | Role | What they receive |
|---|---|---|
| Breast Reconstruction with breast mesh | Experimental | The tissue expander-implant reconstruction with TiLoop Bra mesh. Receives: Procedure: TiLoop Bra mesh in expander-implant breast reconstrution |
| Breast Reconstruction without breast mesh | Active comparator | The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia. Receives: Procedure: sub-pectoral expander-implant breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rates
complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.
Measured: up to 24 months after surgery
Expansion Efficiency
percentage of average injected saline volume to total volume (E=average volume/ total volume）through study completion, an average of 1 year
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
number of revision surgery
To record the rate of surgical revision events on the breast including but not limited to fat tranplantation, reduction mammoplasty/mastompexy, contralateral augmentation,
Measured: from the completion of expander exchange up to 24 months after surgery
aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire
Harris evaluation score was used to evaluate the aesthetic outcome of patients' reconstructed breasts, which was scored as "excellent," "good," "fair," "poor".
Breast-Q questionaire was also used to evaluate the aesthetic outcome of patients' reconstructed breast.
Measured: from the completion of expander exchange up to 24 months after surgery
psychological evaluation by Breast-Q questionnaire
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
Measured: from the completion of expander exchange up to 24 months after surgery
total cost
total cost in RMB per captia
Measured: from expander implation up to the completion of expander exchange,through study completion, an average of 1 year
number of occurrence of deep venous thrombosis
post-operative occurrence of deep venous thrombosis
Measured: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
number of occurrence of non-surgical site infection
post-operative occurrence of non-surgical site infection including but not limited pneumonia, urinary tract infection, etc.
Measured: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967976
- Sponsor's protocol ID
- E20210210
- Status last verified
- Apr 2021
- First submitted
- 10 Jun 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
- ClinicalTrials.gov ID
- NCT04967976
- Acronym / sponsor ID
- E20210210
- Conditions
- Breast Cancer, Radiation, Breast Reconstruction, Synthetic Mesh
- Keywords
- breast cancer, breast reconstruction, radiation, synthetic mesh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 20 Jul 2021 (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.
This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Reconstruction with breast mesh | Experimental | Procedure: TiLoop Bra mesh in expander-implant breast reconstrutionThe tissue expander-implant reconstruction with TiLoop Bra mesh. |
| Breast Reconstruction without breast mesh | Active comparator | Procedure: sub-pectoral expander-implant breast reconstructionThe tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with breast cancer
- More than 18 years old
- Karnofsky Performance Status (KPS) larger than 80
- No clinical or imaging evidence of distant metastasis
- BMI < 35kg/m2
Key exclusion criteria (2 listed)
- 1. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion
- -
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 |
|---|---|---|
| TiLoop Bra mesh in expander-implant breast reconstrutionThe tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral. | Procedure or surgery | Breast Reconstruction with breast mesh |
| sub-pectoral expander-implant breast reconstructionThe tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle/fascia. | Procedure or surgery | Breast Reconstruction without breast mesh |
Primary outcome
Complication Rates
Time frame: up to 24 months after surgery
complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.
Expansion Efficiency
Time frame: through study completion, an average of 1 year
percentage of average injected saline volume to total volume (E=average volume/ total volume）through study completion, an average of 1 year
6 secondary outcomes
number of revision surgery
Time frame: from the completion of expander exchange up to 24 months after surgery
aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire
Time frame: from the completion of expander exchange up to 24 months after surgery
psychological evaluation by Breast-Q questionnaire
Time frame: from the completion of expander exchange up to 24 months after surgery
total cost
Time frame: from expander implation up to the completion of expander exchange,through study completion, an average of 1 year
number of occurrence of deep venous thrombosis
Time frame: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
number of occurrence of non-surgical site infection
Time frame: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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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. This study is not recruiting at the moment.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TiLoop Bra mesh in expander-implant breast reconstrution and sub-pectoral expander-implant breast reconstruction in people with Breast Cancer and Radiation, run by Tianjin Medical University Cancer Institute and Hospital at 6 sites in 3 countries.
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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China, United States, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Yin (+86-22-23340123 ext. 1174, yinjian@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Rates (time frame: up to 24 months after surgery). 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?
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 20 Jul 2021.