Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05848037
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-08
First Post:
2023-04-24
Brief Title:
Assessment of CymActive Catheter Technology for UrinAry ReTention and AcceptancE The ACCTUATE Study
Sponsor:
Prof Philippe Wilson
Organization:
Nottingham Trent University
Study Overview
Official Title:
Assessment of CymActive Catheter Technology for UrinAry ReTention and AcceptancE The ACCTUATE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCTUATE
Brief Summary:
The ACCTUATE Assessment of CymActive Catheter Technology for UrinAry reTention and acceptancE study will begin the formal evaluation of a novel catheter design that addresses the specific needs of people living in the community with long term catheterisation The primary endpoint of the study will be tolerability by measuring AEs SAEs AESIs through day 91 VAS scale assessments 1-10 across insertions and interventions by clinicians The secondary endpoint will be a comparison in the number of re-presentations of patients requiring treatment in primary or secondary care for recurrent CAUTIs in both arms of the study along with comparing both arms to their medical history through routine standard of care
Detailed Description:
There is an urgent need to address sub optimal catheterisation that men experience when living in the community with urinary retention problems The catheters currently used within the NHS in the community settings are typically of the Intermittent or Foley type Foley types are based on a nearly 100-year-old design An inflatable balloon filled with water anchors one end within the bladder At the other end external to the body a bag collects the urine or a valve allows its discharge Intermittent catheters are instead inserted multiple times daily in order to empty the bladder before being removed The amount of times an intermittent is swapped out for a new one depends on the patients condition and the frequency is guided by a Health Care Professional This study will compare the cymactive catheter and foley type catheters
This study has been designed as a pMDCS and is therefore the second phase of medical device assessment with the CCD 1st generation device being CE Marked under the MDD Based upon this and other existing devices such as indwelling catheters and prostatic stents we are confident that the device is safe ACCTUATE is a single-centre study for the assessment of the cymactive catheter device referred to as CCD both in terms of reduction of individuals historic CAUTIs incidence associated with implementation and in terms of tolerance and acceptability of patients and clinicians The CCD will be administered as a replacement for a Foley-type device referred to as FTDand will be implemented for 30 days prior to removal and replacement with another CCD This process will be repeated in 3 30-day cycles The study will consist of two arms the CCD arm and the FTD arm Patients will be recruited equally to each arm of the study
All participants will receive background local standard of care therapy according to participating institutionshospitals regardless of the study group to which they belong 60 participants will be recruited to this study 30 patients in the CCD arm and 30 patients in the FTD The study will begin with the recruitment of a Sentinel group of 20 patients consisting of 10 patients randomised to the CCD arm and 10 patients randomised to the FTD arm Following this a 4-week recruitment pause will take place in order to undertake an interim data capture of the Sentinel group data The Sentinel group will continue to participate in the study during this time as detailed in the Schedule of Activities This will give an opportunity to analyse any AEsSAEs and patient data from the Sentinel group Following this the Study Physician Coordinating Investigator and Sponsor will agree a date for the recommencement of recruitment to the study
Participants will be outpatient male adults 18 years with a documented history of urinary retention based on a postvoidal residue scan cystoscopy urodynamic test or alternative diagnostic means and catheter use and bladder-capacity issues on a long-term basis 4 weeks
This study has been designed as a pMDCS and is therefore the second phase of medical device assessment with the CCD 1st generation device being CE Marked under the MDD Based upon this and other existing devices such as indwelling catheters and prostatic stents we are confident that the device is safe ACCTUATE is a single-centre study for the assessment of the cymactive catheter device referred to as CCD both in terms of reduction of individuals historic CAUTIs incidence associated with implementation and in terms of tolerance and acceptability of patients and clinicians The CCD will be administered as a replacement for a Foley-type device referred to as FTDand will be implemented for 30 days prior to removal and replacement with another CCD This process will be repeated in 3 30-day cycles The study will consist of two arms the CCD arm and the FTD arm Patients will be recruited equally to each arm of the study
All participants will receive background local standard of care therapy according to participating institutionshospitals regardless of the study group to which they belong 60 participants will be recruited to this study 30 patients in the CCD arm and 30 patients in the FTD The study will begin with the recruitment of a Sentinel group of 20 patients consisting of 10 patients randomised to the CCD arm and 10 patients randomised to the FTD arm Following this a 4-week recruitment pause will take place in order to undertake an interim data capture of the Sentinel group data The Sentinel group will continue to participate in the study during this time as detailed in the Schedule of Activities This will give an opportunity to analyse any AEsSAEs and patient data from the Sentinel group Following this the Study Physician Coordinating Investigator and Sponsor will agree a date for the recommencement of recruitment to the study
Participants will be outpatient male adults 18 years with a documented history of urinary retention based on a postvoidal residue scan cystoscopy urodynamic test or alternative diagnostic means and catheter use and bladder-capacity issues on a long-term basis 4 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None