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Assessing Safety and Performance of the Novel CytaCoat Foley Catheter

NCT07070921 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-17

No results posted yet for this study

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

Interventions

DEVICE

Foley catheter

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.

Sponsors & Collaborators

  • Sterimed Surgicals (India) Pvt Ltd

    collaborator UNKNOWN

  • CytaCoat AB

    lead INDUSTRY

Principal Investigators

  • Soumya Madhusudhan, MD · Department of Neuro ICU, St John's Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2025-08-31
Completion
2025-09-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070921 on ClinicalTrials.gov