NCT04245930

Brief Summary

This study is the first randomized and controlled study assessing the efficacy and safety of bovine pericardial patch and TiLOOP® bra mesh in patients with immediate implant breast reconstruction

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

January 28, 2020

Last Update Submit

January 30, 2020

Conditions

Implant Breast ReconstructionTiLOOP® Bra MeshBovine Pericardial Patch

Outcome Measures

Primary Outcomes (1)

  • Complication Rates

    The rate of complications in the two groups

    up to 12 months after surgery

Secondary Outcomes (4)

  • Patient satisfaction-Breast-Q questionnaire

    up to 12 months after surgery

  • Cosmetic outcome of reconstructed breast

    Immediately, up to 3 months, 6 months and 12 months after surgery

  • The rate of surgical revision of reconstructed breasts

    up to 12 months after surgery

  • Health economics-inpatient cost

    up to 12 months after surgery, including the cost of surgical revision

Study Arms (2)

Bovine Pericardial Patch

ACTIVE COMPARATOR

Immediate implant breast reconstruction using bovine pericardial patch. n=88

Procedure: Bovine Pericardial Patch in Immediate Implant Breast Reconstruction

TiLOOP® Bra Mesh

EXPERIMENTAL

Immediate implant breast reconstruction using TiLOOP® Bra Mesh. n=88

Procedure: TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction

Interventions

Bovine Pericardial Patch in Immediate Implant Breast ReconstructionPROCEDURE

Patients will receive immediate breast implant reconstruction using Bovine Pericardial Patch

Bovine Pericardial Patch
TiLOOP® Bra Mesh in Immediate Implant Breast ReconstructionPROCEDURE

Patients will receive immediate breast implant reconstruction using TiLOOP® Bra Mesh

TiLOOP® Bra Mesh

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with I\~II stage breast cancer and Intent to receive NSM or SSM and implant based breast reconstruction
  • Do not smoking in the last 4 weeks or more
  • Mental health patients
  • Signed consent to participate

You may not qualify if:

  • Locally advanced stage patients or patients with distal metastasis
  • Patients received thoracic wall radiotherapy or will receive radiotherapy
  • Smoking in the last 4 weeks
  • Anticipated implant volume more than 600cc
  • Patients of pregnancy or lactation
  • Patients received neoadjuvant therapy

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

Study Officials

  • Jian Yin, MD.

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunyong Han, MD.

CONTACT

+86-22-23340123hancy_007@126.com

Jian Yin, MD.

CONTACT

+86-22-23340123yinjian@tjmuch.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

January 28, 2020

First Posted

January 29, 2020

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

CN(1)