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NCT05121454
Validation of Serenno CUO and IAP Measuring Device
trial testing Serenno Sentinel, model Alpha 2.0, software version: 8.0 in Urinary Catheter in 31 participants. Completed in 7 March 2022.
7 March 2022
Quick facts
| Lead sponsor | Tel-Aviv Sourasky Medical Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 31 |
| Start date | 15 November 2021 |
| Primary completion | 7 March 2022 |
| Estimated completion | 7 March 2022 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Serenno Sentinel, model Alpha 2.0, software version: 8.0
Conditions studied
- Urinary Catheter — all drugs for Urinary Catheter →
- Laparoscopic Surgery — all drugs for Laparoscopic Surgery →
Sponsor
Tel-Aviv Sourasky Medical Center
Who can join
Adults 18 to 85, any sex, with Urinary Catheter or Laparoscopic Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Serenno Medical Automatic Urine Output measuring device is intended to measure volumetric flow rate (total volume and rate) of urine produced per minute over long periods by a patient with a urinary catheter as well as high resolution IAP via bladder pressure (IBP). The device comprises a control unit located near the bed, and a disposable unit connected between the catheter and the urine collection tube/bag. The disposable unit is connected to the control unit with a tube. Frequent and accurate Intra-Abdominal Pressure measurements facilitate management of critical care patients, yet this parameter is normally measured manually, intermittently, and inaccurately. Automating IAP measurement will increase responsiveness, reduce workload, and potentially improve outcomes. The investigators goal is to validate the accuracy urinary catheter estimates of IAP compared to the gold standard during the application of a wide range of pressures controlled by a validated closed-loop insufflation reference. Primary Objective: The study objective is to evaluate the accuracy of the Serenno Medical IAP measurements in patients with indwelling urinary catheters vs. the gold standard - the Foley Manometer
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Assessment of Intra-Abdominal Pressure with a Novel Continuous Bladder Pressure Monitor-A Clinical Validation Study.
Iacubovici L, Karol D, Baar Y, Beri A, et al · · 2023 · cited 8× · PMID 36836741 · DOI 10.3390/life13020384
Verify or expand the search:
- PubMed search for NCT05121454
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05121454 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tel-Aviv Sourasky Medical Center
- Last refreshed: 12 April 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/NCT05121454.
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