Clinical trial · Interventional
Clinical Investigation of the Multi4 System
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients With Suspected Recurrent Bladder Cancer Lesions
NCT06136312CI-TRIAL-00088310completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients with Suspected Recurrent Bladder Cancer Lesions
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi4 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multi4 procedure
- description
- Complete TURBT procedure performed in local anesthesia with Multi4 instrument via flexible cystoscopy
- interventionNames
- Device: Multi4
Primary outcomes (1)
- measure
- Evaluable biopsies
- timeFrame
- At procedure
- description
- Biopsies collected by the instrument are evaluable by pathologist
Secondary outcomes (9)
- measure
- Number of participants with treatment-related adverse events
- timeFrame
- One week
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previous bladder cancer Ta/T1 G1-3 * Recurrence of urinary superficial/ non-muscle-invasive bladder cancer visible at cystoscopy, estimated size \< 10 mm * Willingness and ability to provide informed consent * Age ≥18 years Exclusion Criteria: * Implantable Cardioverter Defibrillator (ICD) that cannot be inactivated * Current/ongoing untreated urinary tract infection * Pregnancy or breastfeeding * Be identified by the Investigator as inappropriate from a medical or compliance perspective to participate in this investigation
References
Publications (0)
Data not yet available
No reference posted for this study.