AzTrials
AzTrials

Malignant Biliary StenosisRAINBOWNCT06750146

Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis

A study testing Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System in people with Malignant Biliary Stenosis, run by Boston Scientific Corporation at 18 sites in France.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Biliary Stenosis
What is being tested?
Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
18 sitesFrance
Study dates
19 Jun 2025to May 2027
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • CHU de Besançon

    Besançon, 25030

  • Clinique des Cedres, Ramsay Sante

    Cornebarrieu, 31700

  • CHU Limoges

    Limoges, 87042

  • Hopital Prive Jean Mermoz

    Lyon, 69008

  • Clinique Jules Verne

    Nantes, 44300

  • CHU Nice

    Nice, 06202

  • Hopital Saint Antoine

    Paris, 75012

  • Hopital Paris Saint-Joseph

    Paris, 75014

  • Hopital Europeen Georges-Pompidou

    Paris, 75908

  • CHU de Poitiers

    Poitiers, 86021

  • CHU Reims

    Reims, 51092

  • CHRU Hopital Pontchaillou

    Rennes, 35033

  • Clinique Saint-Hilaire

    Rouen, 76000

  • Santé Atlantique

    Saint-Herblain, 44800

  • CHU de Strasbourg

    Strasbourg, 67091

  • CHU Rangueil

    Toulouse, 31059

  • CHRU de Nancy

    Vandœuvre-lès-Nancy, 54500

  • Centre Hospitalier de Vichy

    Vichy, 03200

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hot AXIOS™ Stent and Electrocautery Enhanced Delivery SystemDevice

    Also called Hot AXIOS™

    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.

Study groups in NCT06750146
Study groupRoleWhat they receive
Hot AXIOS™ RecipientsExperimentalThe 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.
Receives: Device: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life Measurement - Jaundice Dimension

    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.

    Measured: 2 months (± 15 days)

Secondary outcomes (11)

  1. Quality of Life Measurement - Non-Jaundice Dimension

    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.

    Measured: 2 months (± 15 days)

  2. Quality of Life Measurement - Global Score

    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.

    Measured: 2 months (± 15 days)

  3. Reduction in Bilirubin (Clinical Success)

    Clinical success is defined as a reduction in bilirubin > 50% at each follow-up compared to baseline.

    Measured: 2 weeks (+ 7 days) and 2 months (± 15 days)

  4. Rate of Resolution of Clinical Symptoms

    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

    Measured: 2 months (± 15 days)

  5. Rate of Reintervention

    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.

    Measured: 2 months (± 15 days)

  6. Chemotherapy Status

    Number of days after study stent implantation to start or continuation of chemotherapy (if applicable).

    Measured: 2 months (± 15 days)

  7. Overall Survival

    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.

    Measured: 2 months (± 15 days)

  8. Progression-Free Survival

    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.

    Measured: 2 months (± 15 days)

  9. Number of Days Alive after Hospital Discharge

    Number of days alive after hospital discharge within 2 months after the placement of the Hot AXIOS™.

    Measured: 2 months (± 15 days)

  10. Rate of Technical Success

    Technical success is defined as the successful placement of the Hot AXIOS™ stent during study procedure.

    Measured: 2 months (± 15 days)

  11. Serious Adverse Events

    Serious adverse events related to the study procedure and/or the Hot AXIOS™ stent.

    Measured: 2 months (± 15 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2024
  2. Study start19 Jun 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06750146
Sponsor's protocol ID
E7209
Acronym
RAINBOW
Status last verified
Oct 2026
First submitted
2 Dec 2024
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System in people with Malignant Biliary Stenosis, run by Boston Scientific Corporation at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life Measurement - Jaundice Dimension (time frame: 2 months (± 15 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06750146.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in