Back to results

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

Primary Purpose

Stricture; Trachea, Malignant Neoplasm

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Airway stent implantation

About this trial

This is an interventional treatment trial for Stricture; Trachea focused on measuring 3D printed, airway stent, carina, distal bronchi

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ruijin Hospital Luwan BranchRecruiting
Shanghai Tongren HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Airway Stent for Malignant Stricture

Arm Description

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

Outcomes

Primary Outcome Measures

Improvement in Dyspnea using Hugh-Jones classication as criteria

Hugh-Jones classication: dyspnea scale that includes 5 categories.

Stent patency time

Stent patency time is defined as the time from the stent implantation to stent restenosis or death due to any cause, or censored at date last known alive.

Overall survival

OS is defined as the time from the stent implantation to death due to any cause, or censored at date last known alive.

Secondary Outcome Measures

Number of participants with adverse events that are related to stent implantation

Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion

Full Information

NCT ID

NCT03890575

First Posted

March 19, 2019

Last Updated

February 7, 2020

Sponsor

Ruijin Hospital

Collaborators

Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Tong Ren Hospital, Ruijin Hospital Luwan Branch

1. Study Identification

Unique Protocol Identification Number

NCT03890575

Brief Title

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

Official Title

Covered Metallic Segmented Airway Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

November 1, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

Collaborators

Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Tong Ren Hospital, Ruijin Hospital Luwan Branch

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stricture; Trachea, Malignant Neoplasm

Keywords

3D printed, airway stent, carina, distal bronchi

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Airway Stent for Malignant Stricture

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Airway stent implantation

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement in Dyspnea using Hugh-Jones classication as criteria

Description

Hugh-Jones classication: dyspnea scale that includes 5 categories.

Time Frame

3 days

Title

Stent patency time

Description

Stent patency time is defined as the time from the stent implantation to stent restenosis or death due to any cause, or censored at date last known alive.

Time Frame

2 months

Title

Overall survival

Description

OS is defined as the time from the stent implantation to death due to any cause, or censored at date last known alive.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Number of participants with adverse events that are related to stent implantation

Description

Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion

Time Frame

2 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhongmin Wang, MD

Phone

0086-13901848333

wzm0722@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Qungang Shan, MD

Phone

0086-15989037568

qungangshan@sjtu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhongmin Wang, MD

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ruijin Hospital Luwan Branch

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ju Gong

Facility Name

Shanghai Tongren Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aiwu Mao

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs