Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis

Last updated: May 14, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System

Clinical Study ID

NCT06750146
E7209
  • Ages > 18
  • All Genders

Study Summary

The study is designed to highlight the effectiveness of the Hot AXIOS™ stent when used in accordance with standard medical practice on the evolution of the quality of life of patients with malignant biliary stenosis requiring drainage of the bile ducts after failure of ERCP, in the two months after stent placement.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients 18 years or older

  2. Willing and able to comply with study procedures and provide written informedconsent

  3. Patients with failed ERCP for treatment of malignant biliary obstruction

  4. Patients for whom an indication for Hot AXIOS™ stent placement has been determined

Exclusion

Exclusion Criteria:

  1. Women who are pregnant, nursing or planning to become pregnant during the study

  2. Patients with immediately resectable tumor

  3. Patients for whom the placement of a double pigtail prosthesis is planned by theinvestigator during the index procedure

  4. Current participation in another investigation drug or device study that couldinterfere with the endpoints of this study

  5. Persons under guardianship or curatorship

Study Design

Total Participants: 162
Treatment Group(s): 1
Primary Treatment: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System
Phase:
Study Start date:
May 01, 2025
Estimated Completion Date:
May 31, 2027

Study Description

The study will evaluate the quality of life in patients with malignant biliary obstruction after the placement of a lumen-apposing metal stent via endoscopic ultrasound, with an emphasis on the improvement of quality of life measured as a reduction in jaundice. Improvement in jaundice is a direct indicator of effective bile drainage and is expected to correlate with an enhancement in overall quality of life. Quality of life will be measured by means of subject response to the EORTC QLQ-BIL21, a component of the European Organization for Research and Treatment of Cancer (EORTC) designed specifically to assess the quality of life in patients with biliary tract cancer. The QLQ-BIL21 consists of 21 questions which aim to evaluate specific symptoms and issues relevant to patients with biliary tract cancer, such as jaundice, pain, digestive problems and the psychosocial impact of the disease.

Connect with a study center

  • CHU de Besançon

    Besançon, 25030
    France

    Site Not Available

  • Clinique des Cedres, Ramsay Sante

    Cornebarrieu, 31700
    France

    Site Not Available

  • CHU Limoges

    Limoges, 87042
    France

    Site Not Available

  • Hopital Prive Jean Mermoz

    Lyon, 69008
    France

    Active - Recruiting

  • Clinique Jules Verne

    Nantes, 44300
    France

    Active - Recruiting

  • CHU Nice

    Nice, 06202
    France

    Site Not Available

  • Hopital Europeen Georges-Pompidou

    Paris, 75908
    France

    Site Not Available

  • Hopital Paris Saint Joseph

    Paris, 75014
    France

    Site Not Available

  • Hopital Saint Antoine

    Paris, 75012
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • CHU Reims

    Reims, 51092
    France

    Site Not Available

  • CHRU Hopital Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • Clinique Saint-Hilaire

    Rouen, 76000
    France

    Site Not Available

  • Santé Atlantique

    Saint Herblain, 44800
    France

    Site Not Available

  • CHU de Strasbourg

    Strasbourg, 67091
    France

    Site Not Available

  • CHU Rangueil

    Toulouse, 31059
    France

    Active - Recruiting

  • CHRU de Nancy

    Vandœuvre-lès-Nancy, 54500
    France

    Site Not Available

  • Centre Hospitalier de Vichy

    Vichy, 03200
    France

    Site Not Available

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