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CTRI Number  CTRI/2025/10/096002 [Registered on: 13/10/2025] 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   Clinical study of NewTech short-term catheter for dialysis patients 
Scientific Title of Study   A prospective, open-label, Single-center, single-arm, interventional clinical investigation to evaluate the safety and performance of the NewTech Short-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/STHC-05/CI-P/083 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  
Heart and General Hospital Cardiology department, Cardiology Division, First floor,7 Vivekanand Marg Panch Batti C Scheme Ashok Nagar Jaipur Rajasthan 302001 
 
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  Cardiology department, Cardiology Division, First floor,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 Short-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.Subjects aged above 18 years requiring short-term vascular access for hemodialysis, hemoperfusion, or apheresis therapy.
2.Subjects for whom percutaneous central venous catheterization is clinically indicated and feasible.
3.Subjects who provide written informed consent prior to participation in the study.
4.Subjects who are clinically stable to undergo elective catheter insertion.
5.Subjects with accessible central venous anatomy for safe catheter placement eg internal jugular or subclavian vein).
6.Willing and able to comply with all study procedures and follow-up requirements.
 
 
ExclusionCriteria 
Details  1.Presence or suspicion of device-related infection, bacteremia, or septicemia.
2.History of severe chronic obstructive pulmonary disease that may complicate venous access.
3.Prior irradiation at the intended catheter insertion site.
4.Previous venous thrombosis or vascular surgical intervention at the intended insertion site.
4.Local tissue conditions preventing proper device stabilization and or tunneling.
5.Known allergy or hypersensitivity to polyurethane, heparin, or any materials used in the device.
6.Participation in another clinical study that may interfere with the current study outcomes.
7.Any medical or psychiatric condition that, in the investigator’s opinion, may render the subject unsuitable for the study or interfere with compliance.
 
 
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 Short-Term Hemodialysis Catheter by assessing procedural success, defined as successful catheter insertion with immediate adequate flow suitable for hemodialysis, hemoperfusion, or apheresis therapy   Screening Day & Procedure day, Post procedure Day2, Follow up Day7, Follow up Day30 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the usability and handling characteristics of the catheter as reported by healthcare professionals, including ease of insertion, catheter positioning, and overall operability.
2.To evaluate the functional performance of the catheter during routine clinical use, such as adequacy of flow and reliability of connections.
3.To monitor the incidence and type of adverse events or complications, including but not limited to infections, thrombosis, dislodgement, and device malfunction.
4.To collect qualitative and quantitative feedback from users regarding catheter management, patient safety, and ease of care.
5.To identify and document any device-related issues or operational concerns encountered throughout the study period.
 		 Screening Day & Procedure day, Post procedure Day2, Follow up Day7, Follow up Day30 
 
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)   20/10/2025 
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, interventional, open-label, single-arm clinical study designed to evaluate the performance, safety, and usability of the NewTech Short-Term Hemodialysis Catheter in real-world clinical settings for patients requiring temporary vascular access for hemodialysis, hemoperfusion, or apheresis therapy.

A total of 90 adult subjects (aged above 18 years) will be enrolled across single hospital site. Each subject will undergo catheter insertion via a central vein (e.g., internal jugular or femoral) on Day 1, followed by structured assessments throughout the catheter use period and post-removal until Day 30 from insertion. The expected in-use duration of the catheter ranges from 5 to 14 days, depending on the patient’s clinical condition.

The study includes defined evaluation time points on Day 7 , and Day 30  to assess device performance, clinical site outcomes, and any adverse events. Subjects will continue to be monitored even after catheter removal to capture potential delayed complications such as infection, thrombosis, or device-related irritation.

 
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