Last reviewed · How we verify
NCT05644912
Exploratory Investigation on a Novel Catheter
NA trial testing Transanal irrigation (TAI) in Bowel Dysfunction in 13 participants. Completed in 15 December 2023.
15 December 2023
Quick facts
| Lead sponsor | Wellspect HealthCare |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 13 |
| Start date | 18 November 2022 |
| Primary completion | 15 December 2023 |
| Estimated completion | 15 December 2023 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Transanal irrigation (TAI)
Conditions studied
- Bowel Dysfunction — all drugs for Bowel Dysfunction →
Sponsor
Wellspect HealthCare
Who can join
Adults 18 to 80, any sex, with Bowel Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter. In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI. Each subject will be followed during approximately one week, depending on the usual time between their TAI.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05644912
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bowel Dysfunction
Currently open trials in the same condition.
- NCT06587841 — Noninvasive Spinal Cord Stimulation for Early SCI · NA · recruiting
- NCT05380856 — Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction · NA · recruiting
- NCT06311110 — Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD · recruiting
- NCT06288464 — Enteral Feeding of Fibre to Improve Microbiota · NA · recruiting
Other Wellspect HealthCare trials
Trials by the same sponsor.
- NCT06385249 — An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents · NA · completed
- NCT06377280 — En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device. · NA · completed
- NCT04703413 — User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process. · NA · terminated
- NCT04304599 — Evaluation of a New Female Urinary Intermittent Catheter · NA · completed
- NCT05359198 — Patient Reported Outcome Study on Long Term LoFric Users · unknown
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 NCT05644912 (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 Wellspect HealthCare
- Last refreshed: 24 April 2024
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/NCT05644912.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing