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A novel drug-coated airway stent to explore the treatment of malignant airway stenosis

A novel drug-coated airway stent to explore the treatment of malignant airway stenosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035790
Enrollment
Unknown
Registered
2020-08-16
Start date
2021-01-09
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

Lung cancer

Interventions

experimental group 1:novel airway stent implantation (plan 1)
control group:Ultraflex stent implantation
experimental group 2:novel airway stent implantation (plan 1)
experimental group 3:novel airway stent implantation (plan 3)
experimental group 4:novel airway stent implantation (plan 4)
experimental group 5:novel airway stent implantation (plan 5)

Sponsors

Shanghai Pulmonary Hospital Affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The subjects should be Chinese citizens aged 18 to 60 years old; 2) At screening and baseline follow-up, the subjects must be cby pathologically-onfirmed as lung cancer with malignant airway stenosis; 3) The subjects were in good health and had no clinically significant diseases that may interfere with the trial schedule or operation or affecte the safety of the subjects; 4) The patients should be able to comply with the medication and follow-up schedule.

Exclusion criteria

Exclusion criteria: 1) Subjects with severe upper respiratory tract infection; 2) Subjects with any clinical abnormalities in vital signs at screening or follow-up; 3) Subjects with severe cardiovascular, pulmonary, renal, liver, metabolic, hematological or neurologic diseases, or impaired immune system; 4) Subjects whose airway had been treated with other drugs; 5) Subjects with other reasons that researchers believe they should not be included in the study.

Design outcomes

Primary

MeasureTime frame
OS;Luminal diameter;

Countries

China

Contacts

Public ContactLei Zhang

Shanghai Pulmonary Hospital

ZHANGLEI_FKYY@163.com+86 13816121971

Outcome results

None listed

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