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Investigation of New Intermittent Catheters in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445051
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Tracking Information
First Submitted Date  ICMJE May 28, 2020
First Posted Date  ICMJE June 24, 2020
Last Update Posted Date June 24, 2020
Actual Study Start Date  ICMJE June 2, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2020)
Residual urine at 1st clogging [ Time Frame: Immediately after procedure/catherterization ]
Volume of residual urine at 1st clogging assessed by a pressure sensor with time-logged weighing
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2020)
  • Residual urine post catheterisation [ Time Frame: Immediately after procedure/catherterization ]
    Volume of residual urine post catheterization assessed by ultrasound scan
  • Discomfort [ Time Frame: Immediately after procedure/catherterization and Immediately after first normal voiding after procedure/catherterization. ]
    Discomfort measured using Visual Analogue Scale (VAS). A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain/discomfort is a straight line of 10 cm with one end meaning no pain/discomfort and the other end meaning the worst pain/discomfort imaginable. The subject marks a point on the line that matches the amount of pain/discomfort he or she feels.
  • Adverse events [ Time Frame: Up to 42 days ]
    Number of adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of New Intermittent Catheters in Healthy Volunteers
Official Title  ICMJE Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers
Brief Summary Investigation of non-CE marked intermittent catheters. The study is a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
Detailed Description The CP322 study is an investigation of non-CE marked intermittent catheters which will be conducted in Denmark. The study is a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description:
Single-blinded study
Primary Purpose: Prevention
Condition  ICMJE Retention, Urinary
Intervention  ICMJE Device: New intermittent catheters variation 1 and 2 for both male and females
The new catheters are not named at this point but are intended for intermittent drainage of the bladder.
Study Arms  ICMJE
  • Active Comparator: Standard of care
    SpeediCath® standard Male and Female
    Intervention: Device: New intermittent catheters variation 1 and 2 for both male and females
  • Experimental: New intermittent catheter variation 1 for male and female
    New intermittent catheter variation 1 for male and female
    Intervention: Device: New intermittent catheters variation 1 and 2 for both male and females
  • Experimental: New intermittent catheter variation 2 for male and female
    New intermittent catheter variation 2 for male and female
    Intervention: Device: New intermittent catheters variation 1 and 2 for both male and females
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Is at least 18 years of age and has full legal capacity
  2. Has given written informed consent and signed letter of authority and secrecy agreement
  3. Willing to comply with not using analgesics1 up to 24 hours prior to catheterisation visits
  4. Negative urine multistix - erythrocytes (haematuria)

Exclusion Criteria:

  1. Participation in any other clinical investigations during this investigation
  2. Known hypersensitivity towards any of the test products
  3. Symptoms of urinary tract infections (UTIs) (Investigators judgement)
  4. Pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Johanne L. Gotfredsen, PhD +4549113350 dkjoat@coloplast.com
Contact: Stine Haandbæk Sommersdahl +4549113299 dksths@coloplast.com
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04445051
Other Study ID Numbers  ICMJE CP322
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Coloplast A/S
Study Sponsor  ICMJE Coloplast A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Per Bagi, MD Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
PRS Account Coloplast A/S
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP