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CTRI Number  CTRI/2025/05/087979 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 28/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Feasibility of RIVOS EUS Access Device During Hepaticogastrostomy for Malignant Biliary Obstruction 
Scientific Title of Study   Design Optimization of RIVOS EUS Access Device - A Feasibility Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
97132063 (Version B, 25Mar2025)  Protocol Number 
E7189  Other 
NCT06666699  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sundeep Lakhtakia 
Designation  Professor 
Affiliation   
Address  Asian Institute of Gastroenterology 1-66/AIG/2 to 5, Mindspace Rd P Janardhan Reddy Nagar Gachibowli

Hyderabad
TELANGANA
500032
India 
Phone  919182645727  
Fax    
Email  drsundeeplakhtakia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sundeep Lakhtakia 
Designation  Professor 
Affiliation   
Address  Asian Institute of Gastroenterology 1-66/AIG/2 to 5, Mindspace Rd P Janardhan Reddy Nagar Gachibowli

Hyderabad
TELANGANA
500032
India 
Phone  919182645727  
Fax    
Email  drsundeeplakhtakia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sundeep Lakhtakia 
Designation  Professor 
Affiliation   
Address  Asian Institute of Gastroenterology 1-66/AIG/2 to 5, Mindspace Rd P Janardhan Reddy Nagar Gachibowli

Hyderabad
TELANGANA
500032
India 
Phone  919182645727  
Fax    
Email  drsundeeplakhtakia@gmail.com  
 
Source of Monetary or Material Support  
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 USA 
 
Primary Sponsor  
Name  Boston Scientific Corporation 
Address  100 Boston Scientific Way Marlborough, MA 01752 USA 
Type of Sponsor  Other [Medical device industry-Global] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Belgium
France
India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sundeep Lakhtakia  Asian Institute of Gastroenterology  1-66/AIG/2 to 5, Mindspace Rd P Janardhan Reddy Nagar Gachibowli
Hyderabad
TELANGANA 		 09182645727

drsundeeplakhtakia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Asian Institute of Gastroenterology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K831||Obstruction of bile duct,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  RIVOS EUS Access Device  The RIVOS EUS Access Device is intended to be used in the study by the treating physician to gain access to an obstruction in the biliary duct in patients with malignant biliary obstruction who are undergoing a hepaticogastrostomy. The device will be used only during a portion of the procedure. The entire procedure is expected to last less than two hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. 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

2. 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)


3. 18 years of age or older

4. Patient willing and able to provide written informed consent and comply with specified study visits 
 
ExclusionCriteria 
Details  1. 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

2. Abnormal coagulopathy:
- INR greater than 1.5 and not correctable
- presence of bleeding disorder
- platelets less than 50,000 mm cubed

3. Patient with contraindication to use of electrical devices

4. Female of childbearing potential with a positive pregnancy test prior to the procedure or who intends to become pregnant during the study

5. Patient from a vulnerable population

6. Current participation in another investigational drug or device study that could interfere with the endpoints of this study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Technical success, defined as:
- Access of the target biliary duct, as confirmed via imaging, and
- Ability to advance a wire to guide the procedure through the access cannula after the sharp is removed, and
- Ability to create a cautery fistula for accessory device passage

2. Study device- and study procedure-related serious adverse events (SAEs)

3. Study device performance, evaluated per the following criteria:
- Ability to gain access to the target structure
- Ability to maintain access to the target structure
- Ability to visualize device during necessary procedural steps
- Ability to create a cautery fistula for accessory device passage 		 Screening, Baseline, Day 0 Study Procedure, Day 1 Post-Study Procedure, Day 7 Post-Study Procedure 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="6" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   31/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study primary objective is to assess basic feasibility, safety, and performance in patients with malignant biliary obstruction (MBO) who are indicated to receive endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) for biliary drainage to contribute to design optimization of the RIVOS™ EUS Access Device. As this is a feasibility study with a low enrollment goal, there is no hypothesis. 
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