Airway Segmented Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Distal Bronchi

NCT ID: NCT03890575

Last Updated: 2020-02-11

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2022-12-31

Brief Summary

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In this study, we used the covered metallic segmented airway stent to treat malignant strictures involving carina and bronchi distal to carina and aimed to determine the feasibility, efficacy and safety of this technique.

Detailed Description

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Conditions

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Stricture; Trachea Malignant Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Airway Stent for Malignant Stricture

Patients with malignant stricture were implanted with covered metallic segmented stent modified with 3D printing.

Group Type EXPERIMENTAL

Airway stent implantation

Intervention Type PROCEDURE

The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.

Interventions

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Airway stent implantation

The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with malignant stricture involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy or CT.

Exclusion Criteria

* Severe infection
* Coagulation disorders
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role collaborator

Shanghai Tong Ren Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital Luwan Branch

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongmin Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhongmin Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Ruijin Hospital Luwan Branch

Shanghai, , China

Site Status RECRUITING

Shanghai Tongren Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhongmin Wang, MD

Role: CONTACT

0086-13901848333

Qungang Shan, MD

Role: CONTACT

0086-15989037568

Facility Contacts

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Ju Gong

Role: primary

Aiwu Mao

Role: primary

Other Identifiers

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malignantairwaystent

Identifier Type: -

Identifier Source: org_study_id

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