Assessing Safety and Performance of the Novel CytaCoat Foley Catheter

NCT07070921 | Recruiting

• 1 other identifier: CTRI/2025/05/086528
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-center, single-blind, randomized, parallel assignment, controlled study to evaluate the safety and performance of the novel CytaCoat Foley catheter when compared to a Sterimed uncoated Foley catheter. 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. The primary purpose of the clinical investigation is to determine whether the novel CytaCoat Foley catheter is safe to use in subjects. Safety is assessed by evaluation of adverse events (according to ISO 14155:2020). 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 (Numeric Rating Scale) scale. Furthermore, the exploratory objective of this study is to assess for the presence of bacteriuria in urine and fouling / biofilm analysis of the used catheters.

Conditions

Safety of the CytaCoat Foley Catheter; Performance of the CytaCoat Foley Catheter

Keywords

Safety; Performance; Biofilm; Adverse event; Fouling

Outcome Measures

Primary Outcomes (1)

• Assessment of Safety through incidence of adverse events and serious adverse events of the CytaCoat Foley catheter.

  Adverse events (AEs) and serious adverse events (SAEs) which are further divided into adverse device effects (ADEs) and serious ADEs (SADEs) will be assessed.

  3 - 14 days

Secondary Outcomes (1)

• Assessment of the overall performance related to the CytaCoat Foley catheter using questionnaires.

  3 - 14 days

Other Outcomes (1)

• Microbiological assessment of the catheter after use

  3 - 14 days

Study Arms (2)

CytaCoat Foley catheter

EXPERIMENTAL

CytaCoat Foley catheters will be randomized 1:1 (15 patients in each arm), to patients in need of catheterization for 3 to 14 days.

Device: Foley catheter

Sterimed uncoated Foley catheter

ACTIVE COMPARATOR

Sterimed uncoated Foley catheters will be randomized 1:1 (15 patients in each arm), to patients in need of catheterization for 3 to 14 days.

Device: Foley catheter

Interventions

Foley catheter DEVICE

Drainage of urine from the bladder by transurethral catheterization with an indwelling Foley catheter of patients in need of a Foley catheter for 3 to 14 days.

CytaCoat Foley catheter; Sterimed uncoated Foley catheter

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, male and female, aged 18 to 84 years
• Subjects in need of a urinary catheter for a minimum of 72 hours
• Subjects who can accommodate a size of 14, 16 and 18 French Foley catheter
• Written informed consent
• Subject to be conscious

You may not qualify if:

• Pregnant or breastfeeding women
• Critically ill subjects with a life-threatening disorder (Subjects having an APACHE II score ≥ 28)
• Subject with a known silicone allergy or sensitivity
• Previous enrolment in the present study
• Simultaneous participation in another clinical study that may impact the primary endpoint
• Subject with pre-existing urinary catheter for more than 48 hours
• Subject with symptomatic genitourinary pathology
• Expected severe non-compliance to the protocol as judged by the principal investigator

Sponsors & Collaborators

• CytaCoat AB: lead
• Sterimed Surgicals (India) Pvt Ltd: collaborator

Study Sites (1)

St. John's Medical College Hospital

Bangalore, Karnataka, 560034, India

RECRUITING

Study Officials

• Soumya Madhusudhan, MD

  Department of Neuro ICU, St John's Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soumya Madhusudhan, MD

CONTACT

+91 9980174748; soumyadnb@gmail.com

Mathangi Krishnakumar, MD

CONTACT

+91 9764062212

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The healthcare practitioner placing the catheter will know the allocation (whether it is a CytaCoat Foley catheter or the comparator) but the subject will not know which catheter they have received. The healthcare practitioner removing the catheter may or may not know the allocation. Analyzed catheters for fouling / biofilm assessment will not state which arm the subject is in.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized 1:1 to CytaCoat Foley catheter / Sterimed uncoated Foley catheter (15 subjects in each arm)

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: July 17, 2025
• Study Start: June 2, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)