Clinical trial · Interventional
Global Performance Evaluation of the AMS CONTINUUM™ Device
Global Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
NCT01083199CI-TRIAL-00021704completedPhase 4Results postedClinicalTrials.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)
1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure. 2. To assess clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CONTINUUM™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CONTINUUMTM
- interventionNames
- Device: CONTINUUM™
Primary outcomes (2)
- measure
- Successful Device Placement
- timeFrame
- During Radical Prostatectomy
- description
- Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.
- measure
- Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement
- timeFrame
- 7-21 days post-Device placement
- description
- Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window. The following defines the timeframe of each removal attempt: * 7-day window (7-10 days post-implant) * 14-day window (13-15 days post-implant) * 21-day window (19-21 days post-implant)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * All males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study Exclusion Criteria: * If contraindicated for surgery * Inability to understand the study or a history of non-compliance with medical advice * Unwilling or unable to sign an Informed Consent Form (ICF) * A history of: 1. Recurrent urinary tract infections (UTI) 2. Recurrent stricture disease * Neurological disease with a history of bladder dysfunction (e.g., Parkinson's disease) * Uncontrolled insulin-dependent diabetes * Chemotherapy within the past 6 months * Non-topical steroid use within the past 6 months * Allergy to nitinol, nickel, titanium or silicone
References
Publications (0)
Data not yet available
No reference posted for this study.