NCT05888571

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jul 2023Dec 2026

First Submitted

Initial submission to the registry

May 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 31, 2024

Status Verified

May 1, 2023

Enrollment Period

2.9 years

First QC Date

May 25, 2023

Last Update Submit

January 29, 2024

Conditions

Prepectoral Breast ReconstructionTiLOOP 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

prepectoral breast reconstruction with 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;
  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Central Study Contacts

Jian Yin

CONTACT

+86-22-23340123yinjian@tjmuch.com

Chunyong Han

CONTACT

+86-22-23340123hancy_007@126.com

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

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 31, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)