Bovine Pericardial Patch and TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction.

NCT ID: NCT04245930

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Implant Breast Reconstruction TiLOOP® Bra Mesh Bovine Pericardial Patch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bovine Pericardial Patch

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

Group Type ACTIVE_COMPARATOR

Bovine Pericardial Patch in Immediate Implant Breast Reconstruction

Intervention Type PROCEDURE

Patients will receive immediate breast implant reconstruction using Bovine Pericardial Patch

TiLOOP® Bra Mesh

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

Group Type EXPERIMENTAL

TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction

Intervention Type PROCEDURE

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

Interventions

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Bovine Pericardial Patch in Immediate Implant Breast Reconstruction

Patients will receive immediate breast implant reconstruction using Bovine Pericardial Patch

Intervention Type PROCEDURE

TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Locally advanced stage patients or patients with distal metastasis
2. Patients received thoracic wall radiotherapy or will receive radiotherapy
3. Smoking in the last 4 weeks
4. Anticipated implant volume more than 600cc
5. Patients of pregnancy or lactation
6. Patients received neoadjuvant therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Yin, MD.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunyong Han, MD.

Role: CONTACT

+86-22-23340123 ext. 1174

Jian Yin, MD.

Role: CONTACT

+86-22-23340123 ext. 1171

Facility Contacts

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Chunyong Han, MD.

Role: primary

+86-22-23340123 ext. 1174

Other Identifiers

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E2019453

Identifier Type: -

Identifier Source: org_study_id

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