Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis (RAINBOW)

May 20, 2026 updated by: Boston Scientific Corporation

French Prospective Study on Biliary Tract Drainage Guided by Endoscopic Ultrasound in Patients With Malignant Biliary Stenosis (RAINBOW)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Besançon, France, 25030
        • CHU de Besancon
      • Cornebarrieu, France, 31700
        • Clinique des Cedres, Ramsay Sante
      • Limoges, France, 87042
        • CHU Limoges
      • Lyon, France, 69008
        • Hôpital Privé Jean Mermoz
      • Nantes, France, 44300
        • Clinique Jules Verne
      • Nice, France, 06202
        • CHU Nice
      • Paris, France, 75012
        • Hôpital Saint Antoine
      • Paris, France, 75014
        • Hôpital Paris Saint-Joseph
      • Paris, France, 75908
        • Hopital Europeen Georges-Pompidou
      • Poitiers, France, 86021
        • CHU De Poitiers
      • Reims, France, 51092
        • CHU Reims
      • Rennes, France, 35033
        • CHRU Hopital Pontchaillou
      • Rouen, France, 76000
        • Clinique Saint-Hilaire
      • Saint-Herblain, France, 44800
        • Santé Atlantique
      • Strasbourg, France, 67091
        • CHU de Strasbourg
      • Toulouse, France, 31059
        • CHU Rangueil
      • Vandœuvre-lès-Nancy, France, 54500
        • CHRU de NANCY
      • Vichy, France, 03200
        • Centre Hospitalier de Vichy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients 18 years or older
  2. Willing and able to comply with study procedures and provide written informed consent
  3. Patients with failed ERCP for treatment of suspected malignant biliary obstruction
  4. Patients for whom an indication for Hot AXIOS™ stent placement has been determined

Exclusion Criteria:

  1. Women who are pregnant, nursing or planning to become pregnant during the study
  2. Patients with immediately resectable tumor or resectable during the two months of the study
  3. Patients for whom the placement of a double pigtail prosthesis is planned by the investigator during the index procedure
  4. Current participation in another investigation drug or device study that could interfere with the endpoints of this study
  5. Persons under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hot AXIOS™ Recipients
The Hot AXIOS™ Stent is a flexible, fully covered self-expanding metal stent that is preloaded within the Electrocautery Enhanced Delivery System. Patients who meet all eligibility criteria will receive the Hot AXIOS™stent and their quality of life will be measured at baseline, two weeks after stent placement and two months after stent placement by the jaundice dimension of the EORTC QLQ-BIL21 questionnaire. A patient is considered enrolled after signing the study-specific Informed Consent Form (ICF). Patients who sign the ICF but subsequently do not meet one or more of the selection criteria will be considered screen failures and excluded from the study.
Device: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System
The Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System is commercially available and can be used to bridge two lumens or organs to create an internal drain, so as to drain the bile ducts in case of failure of ERCP.
Other Names:
  • Hot AXIOS™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of Life Measurement - Jaundice Dimension
Time Frame: 2 months (± 15 days)
The primary outcome is the difference between the measurement taken at 2 months of follow-up (± 15 days) and the baseline measurement of quality of life assessed by the jaundice dimension of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-BIL21). The QLQ-BIL21 consists of 21 questions to which respondents rate their experience with various symptoms or problems on a scale from 1 (Not at All) to 4 (Very Much); the jaundice dimension consists of three of those questions. A lower score correlates to fewer symptoms or problems.
2 months (± 15 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Resolution of Clinical Symptoms
Time Frame: 2 months (± 15 days)
Resolution of GOO-related clinical symptoms such as jaundice, nausea/vomiting, fever/chills, weight loss and abdominal pain following implant of Hot AXIOS™ at 2 months of follow-up
2 months (± 15 days)
Rate of Reintervention
Time Frame: 2 months (± 15 days)
Reintervention is defined as endoscopic, radiological or surgical intervention for the management of recurrent biliary obstruction due to stent dysfunction (e.g., obstruction or migration) at 2 months of follow-up. This criterion will be measured within the population for whom the placement of the Hot AXIOS™ stent was a technical success.
2 months (± 15 days)
Chemotherapy Status
Time Frame: 2 months (± 15 days)
Number of days after study stent implantation to start or continuation of chemotherapy (if applicable).
2 months (± 15 days)
Overall Survival
Time Frame: 2 months (± 15 days)
Time from the placement of the Hot AXIOS™ to the date of death from any cause or to the end of follow-up (end of study participation or lost to follow-up) to assess summary measure overall survival.
2 months (± 15 days)
Progression-Free Survival
Time Frame: 2 months (± 15 days)
Time from the placement of the Hot AXIOS™ to the earliest date of either disease progression or death from any cause or to the end of follow-up (end of study participation or lost to follow-up) to assess summary measure progression-free survival.
2 months (± 15 days)
Number of Days Alive after Hospital Discharge
Time Frame: 2 months (± 15 days)
Number of days alive after hospital discharge within 2 months after the placement of the Hot AXIOS™.
2 months (± 15 days)
Rate of Technical Success
Time Frame: 2 months (± 15 days)
Technical success is defined as the successful placement of the Hot AXIOS™ stent during study procedure.
2 months (± 15 days)
Serious Adverse Events
Time Frame: 2 months (± 15 days)
Serious adverse events related to the study procedure and/or the Hot AXIOS™ stent.
2 months (± 15 days)
Quality of Life Measurement - Non-Jaundice Dimension
Time Frame: 2 months (± 15 days)
The absolute difference between the measurement taken at 2 months of follow-up (± 15 days) and the baseline measurement of quality of life assessed by the non-jaundice dimension of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-BIL21). The QLQ-BIL21 consists of 21 questions to which respondents rate their experience with various symptoms or problems on a scale from 1 (Not at All) to 4 (Very Much); the non-jaundice dimension consists of 18 of those questions. A lower score correlates to fewer symptoms or problems.
2 months (± 15 days)
Quality of Life Measurement - Global Score
Time Frame: 2 months (± 15 days)
The absolute difference between the measurement taken at 2 months of follow-up (± 15 days) and the baseline measurement of quality of life assessed by the global score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-BIL21). The QLQ-BIL21 consists of 21 questions to which respondents rate their experience with various symptoms or problems on a scale from 1 (Not at All) to 4 (Very Much). A lower score correlates to fewer symptoms or problems.
2 months (± 15 days)
Reduction in Bilirubin (Clinical Success)
Time Frame: 2 weeks (+ 7 days) and 2 months (± 15 days)
Clinical success is defined as a reduction in bilirubin > 50% at each follow-up compared to baseline.
2 weeks (+ 7 days) and 2 months (± 15 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Baptiste Chevaux, Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E7209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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