Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM (TATUM)
Primary Purpose
Airway Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Custom-designed tracheobronchial prostheses
Sponsored by
About this trial
This is an interventional treatment trial for Airway Disease focused on measuring rigid bronchoscopy, 3D computer-assisted fabrication, silicon-dedicated stent
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- Informed consent
- Complex, proximal and symptomatic (dyspnea, cough, peak flow < 50%, FEV1 < 50% or post-stenotic infection) airway stenosis
Exclusion Criteria:
- Acute respiratory distress, mechanical ventilation
- Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders)
- Pregnancy
Sites / Locations
- University Hospital ToulouseRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3D customized airway stents
Arm Description
Outcomes
Primary Outcome Measures
Percentage of procedures with clinical improvement of the dyspnea
Percentage of procedures with clinical improvement of the dyspnea with questionnaires of Borg, modified Medical Research Council (mMRC), and Dyspnea 12
Percentage of procedures with clinical improvement of quality of life
Percentage of procedures with clinical improvement of quality of life with the VQ11 questionnaire
Secondary Outcome Measures
Percentage of procedures with functional improvement
Percentage of procedures with functional improvement ( forced expiratory volume in one second (FEV1))
Percentage of procedures with congruence of the stent
Percentage of procedures with congruence of the stent with tracheobronchial anatomy on CT-scan at 1 week
Percentage of procedures without complications
Percentage of procedures without complications at 1 week, 3 months, 6 months and 12 months (stent migration, obstructive granuloma, perforation, hemoptysis).
Percentage of procedures with clinical and functional improvement
Percentage of procedures with clinical (dyspnea, cough, quality of life (VQ11 questionnaire)), and functional improvement (peak flow, forced expiratory volume in one second (FEV1)) at 3 months, 6 months and 12 months
Full Information
NCT ID
NCT04848025
First Posted
April 12, 2021
Last Updated
July 21, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT04848025
Brief Title
Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM
Acronym
TATUM
Official Title
Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM (Three-dimensional Airway Tailored Stent Using Computer-aided Modeling)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Airway stenting is usually efficient to treat central airway obstruction but can lead to severe and potentially lethal complications (stent migration, obstructive granuloma, perforation, and hemoptysis).
3D customized airway stents (computer-aided conception using CT-scan data), perfectly suited to airway anatomy, should improve the tolerance and safety of airway stenting.
We demonstrated in a previous pilot study, dedicated to patients with anatomically complex stenoses the safety of 3D patient-specific stents. These appealing results in highly complex situations suggest the need to evaluate these devices in more common situations.
In this study we aim to test our new generation stents in all patients planned for airway stenting. After computer-assisted segmentation of airways (VGStudioMAX 3.0 software), the stenosis is virtually corrected, leading to the conception of a virtual stent (AnatomikModeling, Toulouse), allowing for the fabrication of a mold using a 3D printer. The stent is then built and sterilized (NOVATECH, Berlin) and inserted during rigid bronchoscopy.
Close follow up is then conducted, including clinical evaluation after one week, three, six and 12 months; spirometry at one week, 3 months, 6 months and 12 months and chest CT-scan at one week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Disease
Keywords
rigid bronchoscopy, 3D computer-assisted fabrication, silicon-dedicated stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D customized airway stents
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Custom-designed tracheobronchial prostheses
Intervention Description
Computer-assisted segmentation of airways and stent from CT data (AnatomikModeling) Fabrication of a mold and then a silicon stent by mold injection and sterilization (NOVATECH) Insertion of the stent under rigid bronchoscopy and general anesthesia
Primary Outcome Measure Information:
Title
Percentage of procedures with clinical improvement of the dyspnea
Description
Percentage of procedures with clinical improvement of the dyspnea with questionnaires of Borg, modified Medical Research Council (mMRC), and Dyspnea 12
Time Frame
12 months
Title
Percentage of procedures with clinical improvement of quality of life
Description
Percentage of procedures with clinical improvement of quality of life with the VQ11 questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of procedures with functional improvement
Description
Percentage of procedures with functional improvement ( forced expiratory volume in one second (FEV1))
Time Frame
1 seconde
Title
Percentage of procedures with congruence of the stent
Description
Percentage of procedures with congruence of the stent with tracheobronchial anatomy on CT-scan at 1 week
Time Frame
1 week
Title
Percentage of procedures without complications
Description
Percentage of procedures without complications at 1 week, 3 months, 6 months and 12 months (stent migration, obstructive granuloma, perforation, hemoptysis).
Time Frame
12 months
Title
Percentage of procedures with clinical and functional improvement
Description
Percentage of procedures with clinical (dyspnea, cough, quality of life (VQ11 questionnaire)), and functional improvement (peak flow, forced expiratory volume in one second (FEV1)) at 3 months, 6 months and 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years
Informed consent
Complex, proximal and symptomatic (dyspnea, cough, peak flow < 50%, FEV1 < 50% or post-stenotic infection) airway stenosis
Exclusion Criteria:
Acute respiratory distress, mechanical ventilation
Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders)
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas GUIBERT, MCU-PH
Phone
5 67 77 81 60
Ext
+33
Email
guibert.n@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas GUIBERT, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas GUIBERT, MCU-PH
Phone
5 67 77 81 60
Ext
+33
Email
guibert.n@chu-toulouse.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM
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