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CTRI Number  CTRI/2025/09/094566 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Study to check safety and use of the Newtech long-term dialysis catheter in patients needing dialysis or blood treatments. 
Scientific Title of Study   A prospective, open-label, Single-center, single-arm, interventional clinical investigation to evaluate the safety and performance of the NewTech Long-Term Hemodialysis Catheter for vascular access in patients undergoing hemodialysis, hemoperfusion, or apheresis therapy in real-world clinical settings. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NMDPT/PHC-04/CI-P/082 1.0 dated 04 Aug 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nitin tulsyan 
Designation  MBBS Medicine MD Anesthesia 
Affiliation  Heart and General Hospital Jaipur 
Address  Heart and General Hospital 7 Vivekanand Marg Panch Batti C Scheme Ashok Nagar Jaipur Rajasthan 302001

Jaipur
RAJASTHAN
302001
India 
Phone  9828622007  
Fax    
Email  heartghospital@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Praveen Shukla  
Designation  Regulatory Head 
Affiliation  Newtech Medical Devices PVT LTD 
Address  NewTech Medical Devices Pvt Ltd 14/5 Mathura Road Faridabad Haryana 121003 India

Faridabad
HARYANA
121003
India 
Phone  9717990905  
Fax    
Email  praveenshukla@ntmdevices.in  
 
Details of Contact Person
Public Query  
Name  Mr Praveen Shukla  
Designation  Regulatory Head 
Affiliation  Newtech Medical Devices PVT LTD 
Address  NewTech Medical Devices Pvt Ltd 14/5 Mathura Road Faridabad Haryana 121003 India

Faridabad
HARYANA
121003
India 
Phone  9717990905  
Fax    
Email  praveenshukla@ntmdevices.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Newtech Medical Devices Pvt. Ltd. 
Address  NewTech Medical Devices Pvt Ltd 14/5 Mathura Road, Faridabad Haryana 121003 India  
Type of Sponsor  Other [(Medical device Manufacturer)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nitin Tulsyan  Heart and General Hospital, Jaipur  7 Vivekanand Marg Panch Batti C Scheme Ashok Nagar Jaipur Rajasthan 302001
Jaipur
RAJASTHAN 		 9828622007

heartghospital@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Heart and General Hospital EthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I770||Arteriovenous fistula, acquired,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  NewTech Long-Term Hemodialysis Catheter  The Dialysis Catheter is a chronic, multi-lumen, radiopaque, polyurethane catheter with a polyester cuff and two female Luer locking adapters. The cuff promotes tissue in growth for fixation of the catheter in a subcutaneous tunnel. The Luer locking adapters are color coded to differentiate between the arterial and venous lumens. The red Luer represents arterial outflow from the patient and the blue Luer represents venous return to the patient. In addition, each clamp has tag which is labeled with its respective priming volume. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Adults aged 18 years and above requiring long-term vascular access 30 days or more for maintenance hemodialysis.
2.Patients for whom tunneled central venous catheterization is clinically indicated and feasible.
3.Subjects who are clinically stable and medically cleared to undergo catheter implantation under sterile surgical or interventional conditions.
4.Patients with adequate central venous anatomy eg internal jugular vein or subclavian vein confirmed via imaging or physician assessment.
5.Subjects who provide written informed consent prior to participation.
6.Willing and able to adhere to all study procedures, scheduled follow-up, and maintenance protocols.
 
 
ExclusionCriteria 
Details  1.Presence of local or systemic infection, bacteremia, or septicemia at the time of planned catheterization.
2.History of central vein stenosis or thrombosis at the proposed catheterization site.
3.Prior radiation therapy or surgical modification at the intended catheter insertion site.
4.Known hypersensitivity to materials used in the catheter eg polyurethane, antimicrobial coatings, heparin.
5.Severe coagulopathy or bleeding disorders not corrected before the procedure.
6.Skin conditions or anatomical abnormalities that may impair catheter tunneling or exit site healing.
7.Life expectancy less than 3 months or underlying terminal illness not related to End-Stage Renal Disease ESRD.
8.Participation in another investigational study that may interfere with the current investigation.
9.Any medical or psychiatric condition that, in the opinion of the investigator, could interfere with protocol compliance or place the patient at undue risk.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the clinical safety and performance of the NewTech Long-Term Hemodialysis Catheter by assessing successful catheter placement and sustained functional use, defined as the ability to deliver adequate blood flow for hemodialysis, hemoperfusion, or apheresis therapy over the intended duration of use without device-related failure.   Screening day & Procedure day, Post Procedure Day2, Follow up Day7, Follow up Day30, Follow up Day60 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the usability and handling characteristics of the catheter as reported by healthcare professionals, including ease of insertion, subcutaneous tunneling, fixation stability, and maintenance.
2.To evaluate the long-term functional performance, including flow consistency, catheter patency, and duration of successful use without intervention.
3.To monitor and document the incidence, type, and timing of adverse events or complications, such as CRBSIs, thrombosis, dislodgement, malfunction, or need for replacement.
4.To collect qualitative feedback from clinicians on the overall user experience during long-term care and management.
5.To identify and evaluate any device malfunctions or operational issues, including catheter damage, Luer lock integrity, or difficulty during handling or removal.
 		 Screening day & Procedure day, Post Procedure Day2, Follow up Day7, Follow up Day30, Follow up Day60 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/09/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

This is a prospective, open-label, single-center, single-arm, interventional clinical investigation designed to evaluate the safety and performance of the NewTech Long-Term Hemodialysis Catheter for vascular access in patients undergoing hemodialysis, hemoperfusion, or apheresis therapy in real-world clinical settings.

A total of 90 adult subjects (aged above 18 years) will be enrolled across single hospital or dialysis center. Each subject will receive the NewTech Long-Term Hemodialysis Catheter via percutaneous insertion into a central vein (typically internal jugular) under sterile conditions on Day 1. The catheter is intended for extended use and will remain in place for a variable duration depending on clinical need. Each subject will be followed for 60 days from the date of insertion, regardless of whether the catheter is removed earlier.

 
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