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NCT05785858
FLUME Catheter Comfort Study
trial in Urinary Catheters in 41 participants. Status unknown.
30 March 2024
Quick facts
| Lead sponsor | The Flume Catheter Company Ltd |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 41 |
| Start date | 1 June 2023 |
| Primary completion | 30 March 2024 |
| Estimated completion | 30 March 2024 |
| Sites | 1 location across United States |
Conditions studied
- Urinary Catheters — all drugs for Urinary Catheters →
- Bladder Pain and Discomfort — all drugs for Bladder Pain and Discomfort →
- Urine Leakage — all drugs for Urine Leakage →
- Bladder Spasm — all drugs for Bladder Spasm →
Sponsor
The Flume Catheter Company Ltd
Who can join
18 and older, any sex, with Urinary Catheters or Bladder Pain and Discomfort. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Flume catheter is a commercially available (FDA 510(k) cleared) urethral catheter with an innovative catheter design. The traditional Foley catheter design includes a protruding tip with drainage holes. The protruding tip may contribute to patient discomfort, pain and bladder spasms. The Flume catheter is designed such that the balloon envelops the tip on inflation, thus eliminating the protruding catheter tip, while the drainage holes are inset low in the balloon, providing protection to the bladder lining. Based on the change in design, the hypothesis of this observational cohort study is the Flume catheter will have better patient comfort scores (using validated patient reported outcomes measures) when compared to a traditional catheter.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05785858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05785858 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Flume Catheter Company Ltd
- Last refreshed: 13 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05785858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing