Clinical trial · Interventional
Performance Evaluation of the AMS CONTINUUM™ Device
Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
NCT00894933CI-TRIAL-00031745completedN/AResults 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 assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy. 2. To verify CONTINUUM™ device performance using updated CONTINUUM™ device design modifications, physician procedure guide and training methodology.
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
- Continuum
- description
- Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique.
- interventionNames
- Device: CONTINUUM™
Primary outcomes (9)
- measure
- Safety - Infection That Requires IV Antibiotics or Re-hospitalization
- timeFrame
- At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
- description
- Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
- measure
- Successful Device Placement
- timeFrame
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. * The Subject is willing and able to return for study follow-up visits according to the protocol. * The Subject can be off diuretics and blood thinners for at least one week prior to surgery. 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) * Participation in another clinical trial * Previously implanted urological device * A history of Recurrent urinary tract infections (UTI) * A history of stricture disease * Prior invasive prostate treatments (e.g., TURP, TUIP, laser therapy, radiotherapy, cryotherapy) * 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 * History of connective tissue or autoimmune conditions * Compromised immune system * Allergy to nitinol, nickel, titanium or silicone * Body Mass Index greater than or equal to 30 * American Society of Anesthesiologists Score of \> 3 * Prostate size greater than or equal to 50 grams as determined by TRUS
References
Publications (0)
Data not yet available
No reference posted for this study.