Skip to content

The clinical research of software for quantitative analysis of airway morphology assisting in airway stent design

The clinical research of software for quantitative analysis of airway morphology assisting in airway stent design

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041774
Enrollment
Unknown
Registered
2021-01-05
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cental airway stenosis

Interventions

experimental group:analyze airway with an intelligent software and bronchoscopy to assist in airway stent design
control group:analyze airway with CT post-processing technology and bronchoscpy to assist in airway stent design

Sponsors

the First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age between 16-65 years old; 2. Patients who meet any of the following items(1)(2)(3)and(4), and after doctor's evaluation, it is clear that an airway stent is needed. (1) The narrowing of trachea and main bronchus exceeds 2/3 of the diameter; (2) The narrowing of trachea and main bronchus exceeds 1/2 of the diameter, and the patient has obvious chest tightness, shortness of breath and repeated infections at the distal end of the stenosis; (3) Patient who was confirmed to be a tracheal fistula/bronchial fistula patient after oral contrast agent X-ray, gastroscope, bronchoscopy and other related examinations; (4) The curative effect of general interventional therapy (balloon expansion, freezing, etc.) is difficult to maintain. 3. Patients have clear mind, clear speech, and cooperative behavior; 4. Patients taking study voluntarily and signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are contraindications to bronchoscopy that cannot be corrected in a short time; 2. Patients with a positive pregnancy test or lactating women; 3. Patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system, mentally ill; 4. Subjects who are participating in other drug clinical trials or intervention studies; 5. Patients refusing to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Complication rate and severity;

Secondary

MeasureTime frame
effective rate;success rate of stent placement;

Countries

China

Contacts

Public Contactli Yishi

The First Affiliated Hospital of Chongqing Medical University

KEVIN2003LEE@163.COMNot stated

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026