Trials Sponsors Conditions Drugs Pricing

Conditions

Prepectoral Breast Reconstruction TiLOOP Mesh

Outcome Measures

Primary Outcomes (2)

Major Complication Rates
The rate of major complications in the two groups
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.
up to 12 months after surgery

Secondary Outcomes (4)

Minor Complication Rates
up to 12 months after surgery
Rates of capsule contracture
up to 24 months after surgery
The rate of surgical revision of reconstructed breasts
up to 12 months after surgery
The rate of implant or tissue expander removal
up to 12 months after surgery

Study Arms (2)

prepectoral breast reconstruction with Mesh

ACTIVE COMPARATOR

Immediate prepectoral breast reconstruction with Mesh

Procedure: prepectoral breast reconstructionProcedure: Tiloop Mesh implantation

prepectoral breast reconstruction without Mesh

EXPERIMENTAL

Immediate prepectoral breast reconstruction without Mesh

Procedure: prepectoral breast reconstruction

Interventions

prepectoral breast reconstructionProcedure

Patients receive immediate prepectoral breast reconstruction

prepectoral breast reconstruction with Meshprepectoral breast reconstruction without Mesh

Tiloop Mesh implantationProcedure

Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh

Eligibility Criteria

Age18 Years - 65 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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;

Sponsors & Collaborators

Tianjin Medical University Cancer Institute and Hospital
Otherlead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Chunyong Han, MD.CONTACT+86-22-23340123 ext. 1174 hancy_007@126.com

Jian Yin, MD.PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Yin

CONTACT

+86-22-23340123 yinjian@tjmuch.com

Chunyong Han

CONTACT

+86-22-23340123

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 5, 2023

Study Start

July 1, 2023

Actual (reported)

Primary Completion

June 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Pre-pectoral Breast Reconstruction With or Without Mesh

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

prepectoral breast reconstruction with Mesh

prepectoral breast reconstruction without Mesh

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

prepectoral breast reconstruction with Mesh

prepectoral breast reconstruction without Mesh

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations