Last reviewed · How we verify
NCT06377280
En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device.
NA trial testing Navina Mini in Bowel Dysfunction in 40 participants. Completed in 13 December 2024.
13 December 2024
Quick facts
| Lead sponsor | Wellspect HealthCare |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 18 January 2024 |
| Primary completion | 13 December 2024 |
| Estimated completion | 13 December 2024 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Navina Mini
Conditions studied
- Bowel Dysfunction — all drugs for Bowel Dysfunction →
Sponsor
Wellspect HealthCare
Who can join
18 and older, any sex, with Bowel Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks. Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact.
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 NCT06377280
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Navina Mini
Trials testing the same drug.
- NCT06385249 — An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents · NA · completed
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
- NCT05644912 — Exploratory Investigation on a Novel Catheter · 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 NCT06377280 (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: 31 January 2025
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/NCT06377280.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing