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Search / Trial NCT02620319

Biodegradable Stents in the Management of Stenoses of the Large Airways

Launched by LUDEK STEHLIK · Dec 2, 2015

Trial Information

Current as of August 11, 2025

Suspended

Keywords

Bronchoscopy Polydioxanone Absorbable Implants Stents

ClinConnect Summary

Background:

The ideal airway stent has yet to be developed. Biodegradable (BD) stents are made of knitted polymer fibers that degrade when placed in the body; extraction of the device is, therefore, unnecessary. Several in vitro and in vivo studies of tracheal BD stents composed of various materials have been conducted.

Polydioxanone is a biodegradable polymer in the polyester family, which has attracted a lot of interest due to its exquisite biocompatibility and is currently available on the market in the form of absorbable suture material. It is degraded by hydrolysis (of its ester bond...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • significant large airway stenoses
  • benign tracheobronchial stenosis of any origin in participants who can not go for surgery, or who refuse surgical treatment
  • benign tracheobronchial stenoses of any origin when the surgery is planed after some delay, benign tracheobronchial stenoses when the effect of anti- inflammatory or anti-infective treatment is expected
  • malignant tracheobronchial stenoses due to extrinsic compression when exhausted curative modalities
  • malignant stenoses from extrinsic compression in participants undergoing the actinotherapy or receiving systemic anticancer therapy
  • Exclusion Criteria:
  • stenoses of any origin which can be treated primarily surgically
  • stenoses caused by intraluminal growth of tumor, tracheoesophageal or bronchoesophageal fistulas
  • pregnancy

About Ludek Stehlik

Ludek Stehlik is a dedicated clinical trial sponsor specializing in the advancement of innovative therapies through rigorous research and development. With a focus on enhancing patient outcomes, the organization collaborates with leading research institutions and healthcare professionals to design and implement clinical studies that adhere to the highest ethical and regulatory standards. Committed to transparency and scientific integrity, Ludek Stehlik leverages cutting-edge methodologies and a patient-centric approach to drive the successful progression of novel treatments from conception to market.

Locations

Olomouc, , Czech Republic

Prague, , Czech Republic

Prague, , Czech Republic

Olomouc, , Czechia

Prague, , Czechia

Prague, , Czechia

Patients applied

0 patients applied

Trial Officials

Ludek Stehlik, MUDr.

Principal Investigator

Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4

Miloslav Marel, Prof. MUDr.

Study Director

Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital

Vitezslav Kolek, Prof. MUDr.

Study Director

Department of Respiratory Diseases and Tuberculosis, University Hospital Olomouc

Martina Vasakova, Prof. MUDr.

Study Director

Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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