Malignant Biliary ObstructionNCT06666699
RIVOS Feasibility (MBO)
A study testing EUS access device in people with Malignant Biliary Obstruction, run by Boston Scientific Corporation at 3 sites in 3 countries.
Trial summary
The goal of this clinical trial is to assess basic feasibility, safety, and performance of an EUS access device in patients with malignant biliary obstruction who are indicated to receive EUS-guided hepaticogastrostomy for biliary drainage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- EUS access device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 31 Aug 2025to 30 May 2026
- 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
- Patient with malignant biliary obstruction and who is indicated to receive EUS-guided hepaticogastrostomy for biliary drainage, as documented by dilated left hepatic duct and hyperbilirubinemia
- Patient who failed ERCP (e.g., inability to access the obstructed biliary system via a transpapillary route) or for whom ERCP is not an option (e.g., due to altered anatomy, gastric outlet obstruction)
- 18 years of age or older
- Patient willing and able to provide written informed consent and comply with specified study visits
Who cannot join
- Patient whose general medical condition and degree of respiratory failure would not allow them to tolerate endoscopy and/or the manipulation required to perform the study procedure
- Abnormal coagulopathy:
- INR \>1.5 and not correctable
- presence of bleeding disorder
- platelets \<50,000 mm3
- Patient with contraindication to use of electrical devices
Show all 9Show fewer
- Female of childbearing potential with a positive pregnancy test prior to the procedure or who intends to become pregnant during the study
- Patient from a vulnerable population
- Current participation in another investigational drug or device study that could interfere with the endpoints of this study
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Design Optimization of RIVOS EUS Access Device - A Feasibility Study
The goal of this clinical trial is to assess basic feasibility, safety, and performance of an EUS access device in patients with malignant biliary obstruction who are indicated to receive EUS-guided hepaticogastrostomy for biliary drainage. The main questions it aims to answer are:
- Can the device be used to gain and maintain access to target anatomy?
- Does the device have a clinically acceptable safety profile?
- How does the device perform overall?
All patients will undergo a hepaticogastrostomy procedure and be followed for 7 days post-procedure.
- Conditions
- Malignant Biliary Obstruction
- Being tested
- EUS access device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS access deviceDevice
The intervention involves the use of an EUS access device to gain access to the bile duct via hepaticogastrostomy.
| Study group | Role | What they receive |
|---|---|---|
| RIVOS | Experimental | Not described Receives: Device: EUS access device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Defined as (1) access of the target biliary duct, as confirmed via imaging, (2) ability to advance a wire to guide the procedure through the access cannula after the sharp is removed, and (3) ability to create a cautery fistula for accessory device passage
Measured: Day 0 Study Procedure
Safety
Study device- and study procedure-related serious adverse events
Measured: Day 0 Study Procedure through Day 7 Post-Study Procedure
Device Performance
Evaluated per the following criteria (1) ability to gain access to the target structure, (2) ability to maintain access to the target structure, (3) ability to visualize device during necessary procedural steps, and (4) ability to create a cautery fistula for accessory device passage
Measured: Day 0 Study Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start31 Aug 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Why it stopped: Study has been withdrawn per decision of Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sundeep Lakhtakia, MD, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666699
- Sponsor's protocol ID
- E7189
- Status last verified
- Sep 2025
- First submitted
- 11 Oct 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design Optimization of RIVOS EUS Access Device - A Feasibility Study
- ClinicalTrials.gov ID
- NCT06666699
- Acronym / sponsor ID
- E7189
- Conditions
- Malignant Biliary Obstruction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been withdrawn per decision of Sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess basic feasibility, safety, and performance of an EUS access device in patients with malignant biliary obstruction who are indicated to receive EUS-guided hepaticogastrostomy for biliary drainage. The main questions it aims to answer are:
- Can the device be used to gain and maintain access to target anatomy?
- Does the device have a clinically acceptable safety profile?
- How does the device perform overall?
All patients will undergo a hepaticogastrostomy procedure and be followed for 7 days post-procedure.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIVOS | Experimental | Device: EUS access device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with malignant biliary obstruction and who is indicated to receive EUS-guided hepaticogastrostomy for biliary drainage, as documented by dilated left hepatic duct and hyperbilirubinemia
- Patient who failed ERCP (e.g., inability to access the obstructed biliary system via a transpapillary route) or for whom ERCP is not an option (e.g., due to altered anatomy, gastric outlet obstruction)
- 18 years of age or older
- Patient willing and able to provide written informed consent and comply with specified study visits
Key exclusion criteria (9 listed)
- Patient whose general medical condition and degree of respiratory failure would not allow them to tolerate endoscopy and/or the manipulation required to perform the study procedure
- Abnormal coagulopathy:
- Patient with contraindication to use of electrical devices
- Female of childbearing potential with a positive pregnancy test prior to the procedure or who intends to become pregnant during the study
- Patient from a vulnerable population
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS access deviceThe intervention involves the use of an EUS access device to gain access to the bile duct via hepaticogastrostomy. | Device | RIVOS |
Primary outcome
Technical Success
Time frame: Day 0 Study Procedure
Defined as (1) access of the target biliary duct, as confirmed via imaging, (2) ability to advance a wire to guide the procedure through the access cannula after the sharp is removed, and (3) ability to create a cautery fistula for accessory device passage
Safety
Time frame: Day 0 Study Procedure through Day 7 Post-Study Procedure
Study device- and study procedure-related serious adverse events
Device Performance
Time frame: Day 0 Study Procedure
Evaluated per the following criteria (1) ability to gain access to the target structure, (2) ability to maintain access to the target structure, (3) ability to visualize device during necessary procedural steps, and (4) ability to create a cautery fistula for accessory device passage
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sundeep Lakhtakia, MD principal investigator
Asian Institute of Gastroenterology, India
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS access device in people with Malignant Biliary Obstruction, run by Boston Scientific Corporation at 3 sites in 3 countries.
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 9 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: withdrawn, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, France, India. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Technical Success (time frame: Day 0 Study Procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2025.