Prepectoral Breast ReconstructionNCT05888571
Pre-pectoral Breast Reconstruction With or Without Mesh
A study testing prepectoral breast reconstruction and Tiloop Mesh implantation in people with Prepectoral Breast Reconstruction and TiLOOP Mesh, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Prepectoral Breast Reconstruction, TiLOOP Mesh
- What is being tested?
- prepectoral breast reconstruction and Tiloop Mesh implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to Dec 2026
- Phase
- Interventional
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
- SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
- Tissue expander size =<800cc, implant size =<600cc;
- The blood perfusion of breast skin flap was well;
- Do not smoking in the last 4 weeks or more
- Patients with normal expectations and mental health for breast reconstruction;
- Signed consent to participate
Who cannot join
- Poor perfusion of breast mastectomy flap;
- II stage breast reconstruction patients;
- History of chest radiotherapy;
- BMI greater than 35;
- Patients who have not quit smoking within the last 4 weeks;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Chunyong Han, MD., +86-22-23340123 ext. 1174, hancy_007@126.com
Jian Yin, MD.
About this study
Official title: A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh
To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.
Read the detailed description
The clinical study aims to explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that not using TiLOOP Mesh.
- Conditions
- Prepectoral Breast Reconstruction, TiLOOP Mesh
- Being tested
- prepectoral breast reconstruction, Tiloop Mesh implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prepectoral breast reconstructionProcedure or surgery
Patients receive immediate prepectoral breast reconstruction
Tiloop Mesh implantationProcedure or surgery
Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh
| Study group | Role | What they receive |
|---|---|---|
| prepectoral breast reconstruction with Mesh | Active comparator | Immediate prepectoral breast reconstruction with Mesh Receives: Procedure: prepectoral breast reconstruction; Procedure: Tiloop Mesh implantation |
| prepectoral breast reconstruction without Mesh | Experimental | Immediate prepectoral breast reconstruction without Mesh Receives: Procedure: prepectoral breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Complication Rates
The rate of major complications in the two groups
Measured: up to 12 months after surgery
Patient Breast-Q questionnaire
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
Measured: up to 12 months after surgery
Secondary outcomes (4)
Minor Complication Rates
The rate of minor complications in the two groups
Measured: up to 12 months after surgery
Rates of capsule contracture
The rates of capsule contracture in the two groups
Measured: up to 24 months after surgery
The rate of surgical revision of reconstructed breasts
To record the rate of surgical revision events of the reconstructed breasts
Measured: up to 12 months after surgery
The rate of implant or tissue expander removal
The rate of implant or tissue expander removal in the two groups
Measured: up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jul 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prepectoral 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 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
- NCT05888571
- Sponsor's protocol ID
- E20230013
- Status last verified
- May 2023
- First submitted
- 25 May 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh
- ClinicalTrials.gov ID
- NCT05888571
- Acronym / sponsor ID
- E20230013
- Conditions
- Prepectoral Breast Reconstruction, TiLOOP Mesh
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jun 2023 (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.
To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.
Detailed description
The clinical study aims to explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that not using TiLOOP Mesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prepectoral breast reconstruction with Mesh | Active comparator | Procedure: prepectoral breast reconstruction, Procedure: Tiloop Mesh implantationImmediate prepectoral breast reconstruction with Mesh |
| prepectoral breast reconstruction without Mesh | Experimental | Procedure: prepectoral breast reconstructionImmediate prepectoral breast reconstruction without Mesh |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
- SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
- Tissue expander size =<800cc, implant size =<600cc;
- The blood perfusion of breast skin flap was well;
- Do not smoking in the last 4 weeks or more
Key exclusion criteria (5 listed)
- Poor perfusion of breast mastectomy flap;
- II stage breast reconstruction patients;
- History of chest radiotherapy;
- BMI greater than 35;
- Patients who have not quit smoking within the last 4 weeks;
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 |
|---|---|---|
| prepectoral breast reconstructionPatients receive immediate prepectoral breast reconstruction | Procedure or surgery | prepectoral breast reconstruction with Mesh, prepectoral breast reconstruction without Mesh |
| Tiloop Mesh implantationPatients receive immediate prepectoral breast reconstruction with Tiloop Mesh | Procedure or surgery | prepectoral breast reconstruction with Mesh |
Primary outcome
Major Complication Rates
Time frame: up to 12 months after surgery
The rate of major complications in the two groups
Patient Breast-Q questionnaire
Time frame: up to 12 months after surgery
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
4 secondary outcomes
Minor Complication Rates
Time frame: up to 12 months after surgery
Rates of capsule contracture
Time frame: up to 24 months after surgery
The rate of surgical revision of reconstructed breasts
Time frame: up to 12 months after surgery
The rate of implant or tissue expander removal
Time frame: up to 12 months 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 31 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prepectoral breast reconstruction and Tiloop Mesh implantation in people with Prepectoral Breast Reconstruction and TiLOOP Mesh, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 7 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: looking for participants now, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Jian Yin (+86-22-23340123 ext. 1171, yinjian@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Complication Rates (time frame: up to 12 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 31 Jan 2024.