| CTRI Number |
CTRI/2025/05/086528 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the safety and performance of the
CytaCoat Foley catheter through a randomized, controlled trial with two parallel groups. |
|
Scientific Title of Study
|
Assessing the safety and performance of the novel CytaCoat
Foley catheter: A prospective randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DD-2305-200 , Version: 02 ,Date: 2024-10-23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soumya Madhusudhan |
| Designation |
Neuro Anaesthetist and Intensivist |
| Affiliation |
St.Johns Medical College Hospital |
| Address |
Floor No.02, Room No. 01, Department of Neuro ICU, St Johns Medical College Hospital, Sarjapur Road, Bangalore
KARNATAKA
Bangalore
KARNATAKA
560068
India |
| Phone |
8301856818 |
| Fax |
|
| Email |
soumyadnb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Madhusudhan |
| Designation |
Neuro Anaesthetist and Intensivist |
| Affiliation |
St.Johns Medical College Hospital |
| Address |
Floor No.02, Room No. 01, Department of Neuro ICU, St Johns Medical College Hospital, Sarjapur Road, Bangalore
KARNATAKA
Bangalore
KARNATAKA
560068
India |
| Phone |
8301856818 |
| Fax |
|
| Email |
soumyadnb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya Madhusudhan |
| Designation |
Neuro Anaesthetist and Intensivist |
| Affiliation |
St.Johns Medical College Hospital |
| Address |
Floor No.02, Room No. 01, Department of Neuro ICU, St Johns Medical College Hospital, Sarjapur Road, Bangalore
KARNATAKA
Bangalore
KARNATAKA
560068
India |
| Phone |
8301856818 |
| Fax |
|
| Email |
soumyadnb@gmail.com |
|
|
Source of Monetary or Material Support
|
| CytaCoat AB
Maria Aspmans gata
44A, 171 64 Solna, Sweden |
|
|
Primary Sponsor
|
| Name |
CytaCoat AB |
| Address |
Maria Aspmans gata 44A, 171 64 Solna, Sweden |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Sterimed Group |
501, Ring Road Mall, Mangalam Palace, Sector-3 Rohini,
New Delhi - 110085 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soumya Madhusudhan |
St. John’s Medical College Hospital |
Floor No.02, Room No. 01, Department of Neuro ICU,Sarjapur Road, Bangalore - 560034, Karnataka, India.
Bangalore
KARNATAKA |
8301856818
soumyadnb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee St Johns Medical College Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N30-N39||Other diseases of the urinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CytaCoat Foley catheter |
The CytaCoat catheter is a flexible silicone tube with an inflatable balloon on its tip with one
drainage funnel, one inflation access port at the proximal end and lateral eyes at the distal rounded closed end. An inflated access port is fitted with a non-return valve (NRV) to inflate
and deflate the balloon while the drainage funnel is meant for connection to a urine bag to drain urine from the bladder.The CytaCoat Catheter is made of a silicone Foley balloon 2-way catheter from Sterimed
Group coated with a CytaCoat coating applied to both the inside and the outside of the catheter and the balloon.
The Sterimed catheter that is coated is made from 100% medical grade silicone and is suitable for subjects requiring in-dwelling catheterization.The CytaCoat coating consists of an advanced hydrogel applied to the inner and outer surface
of a silicone Foley catheter. The main component of the hydrogel coating is polyacrylic acid
coupled with a proprietary anti-fouling ligand. The coating will come into direct contact with
the bladder and the urethra. |
| Comparator Agent |
Sterimed uncoated Foley catheter |
The uncoated catheter is a flexible silicone tube with an inflatable balloon on its distal tip with
one drainage funnel and one inflation access port in a 2-way catheter. An inflation access port fitted with NRV to inflate and deflate the balloon while the drainage funnel is meant for
connection to the urine bag to drain urine from the bladder. The Inflation access port with NRV has a colored sleeve for easy identification of the size of the catheter.
The device is packed in
a soft blister made up of polypropylene and polyethylene and medical crepe paper. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
84.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults, male and female, aged 18 to 84 years
2.Subjects in need of a urinary catheter for a minimum of 72 hours
3.Subjects who can accommodate a size of 14, 16 and 18 French Foley catheter
4.Written informed consent
5.Subject to be conscious |
|
| ExclusionCriteria |
| Details |
1.Pregnant or breastfeeding women
2.Critically ill subjects with a life-threatening disorder (Subjects having an APACHE II
score greater equal 28)
3.Subject with a known silicone allergy or sensitivity
4.Previous enrolment in the present study
5.Simultaneous participation in another clinical study that may impact the primary endpoint
6.Subject with pre-existing urinary catheter for more than 48 hours
7.Subject with symptomatic genitourinary pathology
8.Expected severe non-compliance to the protocol as judged by the principal investigator |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adverse events (AEs) and serious adverse events (SAEs) are further divided into adverse device effects (ADEs) and serious ADEs (SADEs). |
1.Minimum of 72 hours
2.Maximum of 14 days of catheter use
3.Telephonic follow-up 7±1 days of catheter removal. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary endpoint assesses the overall performance related to the medical device, based
on Foley catheter usability experience by the healthcare personnel and subjects:
1. Assessment of usability of the Foley catheter by a responsible nurse/physician with the
NRS scale (0-10) using a questionnaire.
2. Assessment immediately after removal of the catheter of pain, irritation, and discomfort
measured with the NRS scale (0-10) using a questionnaire asking subjects about their
experience using the catheter.
3. Telephonic follow-up assessment between 7±1 days after removal of the catheter using
a questionnaire asking subjects about their experience using the catheter. |
1.Minimum of 72 hours
2.Maximum of 14 days of catheter use
3.Telephonic follow-up 7±1 days of catheter removal. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 aims to assess the safety and performance of the CytaCoat Foley catheter through a randomized, controlled trial with two parallel groups.
Participants will include male and female adult subjects who require an indwelling urinary catheter for an expected duration of minimum 72 hours to 14 days. Subjects in the treatment group will receive the CytaCoat Foley catheter, while subjects in the control group will receive a Sterimed uncoated Foley catheter (100% Silicone Foley Balloon catheter). The catheter will be inserted and removed by trained healthcare personnel. The catheter may be removed early, if necessary, in case of the appearance of any of the warning signs The primary objective of this study is to determine the safety of the CytaCoat Foley catheter. The secondary objective is to assess the overall performance of the CytaCoat Foley catheter by evaluating usability experience by the healthcare personnel and subjects measured by using NRS scale.
The study will be an interventional, single-blind, randomized, parallel assignment, and single-centre prospective clinical safety study.
Indication- For urinary incontinence and urinary drainage. The clinical trial is designed to include a sufficient number of subjects who will be screened to enroll a total of 30 subjects for the study. The duration of the clinical study is 6 months.
The expected duration of the subject participation is minimum of 72 hours and a maximum of 14 days of catheter use and a telephonic follow-up 7±1 days of catheter removal.
|